{"id":84472,"date":"2019-04-14T00:00:50","date_gmt":"2019-04-17T03:13:32","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/84472\/"},"modified":"2019-04-17T11:13:33","modified_gmt":"2019-04-17T03:13:33","slug":"5512e6156d","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/84472\/","title":{"rendered":"\u836f\u5305\u6750\u53d8\u66f4\u7ba1\u7406\u7684\u5206\u6790\u4e0e\u63a2\u8ba8"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<p><strong style=\"color: rgb(249, 110, 87);text-align: center;background-color: rgb(247, 247, 247);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box;background-color: rgb(255, 255, 255);word-wrap: break-word !important;\"><img   width=\"100%\"  class=\"__bg_gif\"  style=\"box-sizing: border-box;line-height: 25.6px;vertical-align: middle;word-wrap: break-word !important;visibility: visible !important;width: 97.8281px !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/04\/9-1555470812.gif\" alt=\"\u836f\u5305\u6750\u53d8\u66f4\u7ba1\u7406\u7684\u5206\u6790\u4e0e\u63a2\u8ba8\" title=\"\u836f\u5305\u6750\u53d8\u66f4\u7ba1\u7406\u7684\u5206\u6790\u4e0e\u63a2\u8ba8\"  \/><\/span><\/strong><span style=\"color: rgb(249, 110, 87);text-align: center;background-color: rgb(247, 247, 247);max-width: 100%;font-size: 12px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box;background-color: rgb(255, 255, 255);word-wrap: break-word !important;\">\u70b9\u51fb<strong style=\"max-width: 100%;box-sizing: border-box;line-height: 25.6px;word-wrap: break-word !important;\">\u5173\u6ce8<\/strong><\/span><\/strong><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box;background-color: rgb(255, 255, 255);word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\u2191<\/strong><\/span><\/strong><\/span><span style=\"max-width: 100%;box-sizing: border-box;color: rgb(0, 122, 170);background-color: rgb(255, 255, 255);word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\u6280\u672f\u6c47<\/span><\/strong><\/span><\/span><\/p>\n<pre style=\"max-width: 100%;letter-spacing: 0.544px;color: rgb(62, 62, 62);line-height: 25.6px;font-size: 18px;box-sizing: border-box !important;word-wrap: break-word !important;\"><p style=\"max-width: 100%;min-height: 1em;font-size: 16px;line-height: 25.6px;white-space: normal;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 12px;line-height: 24.381px;box-sizing: border-box !important;word-wrap: break-word !important;overflow-wrap: break-word !important;\">\u6b22\u8fce\u70b9\u8d5e\u548c\u8f6c\u53d1\u54e6~<\/span><img class=\"\"    width=\"14px\"  style=\"font-size: 12px;line-height: 24.381px;border-radius: 0px;box-sizing: border-box !important;word-wrap: break-word !important;overflow-wrap: break-word !important;visibility: visible !important;width: 14px !important;\" src=\"https:\/\/mmbiz.qpic.cn\/mmbiz_png\/SmibgqHu83VMReLInZkRXfK63iaZ9yibCJUGHfnibaeHKezdM69XRISAEDeRvNjwljsgZzyMyXVm9jJ80j1R9QveXg\/640?\"  \/><\/p><section style=\"max-width: 100%;box-sizing: border-box;font-size: 16px;line-height: 25.6px;white-space: normal;word-wrap: break-word !important;overflow-wrap: break-word !important;\"><section class=\"\" style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;overflow-wrap: break-word !important;\"><hr style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;overflow-wrap: break-word !important;\"  \/><section style=\"max-width: 100%;box-sizing: border-box;line-height: 25.6px;word-wrap: break-word !important;overflow-wrap: break-word !important;\"><section class=\"\" style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;overflow-wrap: break-word !important;\"><section class=\"\" style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;overflow-wrap: break-word !important;\"><section class=\"\" style=\"max-width: 100%;box-sizing: border-box;display: inline-block;width: 668px;word-wrap: break-word !important;overflow-wrap: break-word !important;overflow: hidden !important;\"><img class=\"\"    width=\"668px\"  style=\"box-sizing: border-box;vertical-align: middle;word-wrap: break-word !important;overflow-wrap: break-word !important;visibility: visible !important;width: 668px !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/04\/7-1555470812.jpeg\" alt=\"\u836f\u5305\u6750\u53d8\u66f4\u7ba1\u7406\u7684\u5206\u6790\u4e0e\u63a2\u8ba8\" title=\"\u836f\u5305\u6750\u53d8\u66f4\u7ba1\u7406\u7684\u5206\u6790\u4e0e\u63a2\u8ba8\"  \/><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/section><\/section><pre style=\"max-width: 100%;letter-spacing: 0.544px;line-height: 25.6px;font-size: 18px;box-sizing: border-box !important;word-wrap: break-word !important;\"><pre style=\"max-width: 100%;letter-spacing: 0.544px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><section style=\"max-width: 100%;box-sizing: border-box;font-size: 16px;line-height: 25.6px;white-space: normal;word-wrap: break-word !important;overflow-wrap: break-word !important;\"><section class=\"\" style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;overflow-wrap: break-word !important;\"><section style=\"max-width: 100%;box-sizing: border-box;line-height: 25.6px;word-wrap: break-word !important;overflow-wrap: break-word !important;\"><section class=\"\" style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;text-decoration: underline;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(255, 41, 65);box-sizing: border-box !important;word-wrap: break-word !important;\">\u70b9\u51fb\u67e5\u9605&nbsp;<\/span><\/strong><strong style=\"max-width: 100%;letter-spacing: 0.544px;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Helvetica, sans-serif;color: red;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247494290&amp;idx=6&amp;sn=9aa62713d8fe1cbdad89042866da7e12&amp;scene=21#wechat_redirect\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;color: red;font-weight: normal;\">2019<\/span><span style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;font-family: \u7b49\u7ebf;color: red;font-weight: normal;\">\u5236\u836f\u57f9\u8bad\u901a\u77e5<\/span><\/a><\/span><\/strong><\/span><\/section><p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(255, 41, 65);text-decoration: underline;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Helvetica, sans-serif;letter-spacing: 0.5px;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247494279&amp;idx=5&amp;sn=eb663b3b73a24d7e51fb0c7e73da5adf&amp;scene=21#wechat_redirect\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(255, 41, 65);font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">5\u670818-20\u65e5\u3010\u4e0a\u6d77\u3011\u201c<\/span><span style=\"max-width: 100%;color: rgb(255, 41, 65);font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">2019&nbsp;<\/span><span style=\"max-width: 100%;color: rgb(255, 41, 65);font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u65b0\u5efa<\/span><span style=\"max-width: 100%;color: rgb(255, 41, 65);font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">GMP<\/span><span style=\"max-width: 100%;color: rgb(255, 41, 65);font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5de5\u5382\u5de5\u7a0b\u7ba1\u7406\u5b9e\u64cd\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/span><\/p><p style=\"margin-bottom: 15px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6458\u8981<\/strong>\uff1a<\/span><span style=\"max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u76ee\u7684\uff1a<\/strong>\u901a\u8fc7\u6c47\u603b\u5206\u6790\u7f8e\u56fd\u5bf9\u836f\u5305\u6750\u53d8\u66f4\u7684\u7ba1\u7406\u6cd5\u89c4\u548c\u7ba1\u7406\u65b9\u5f0f\uff0c\u4e3a\u6211\u56fd\u5b9e\u65bd\u5173\u8054\u5ba1\u8bc4\u5ba1\u6279\u540e\u5bf9\u836f\u5305\u6750\u53d8\u66f4\u7ba1\u7406\u63d0\u4f9b\u501f\u9274\uff0c\u4ece\u800c\u4fdd\u8bc1\u836f\u54c1\u5728\u6574\u4e2a\u751f\u547d\u5468\u671f\u5185\u7684\u5b89\u5168\u3001\u6709\u6548\u548c\u8d28\u91cf\u53ef\u63a7\u3002<\/span><span style=\"max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u65b9\u6cd5\uff1a<\/strong>&nbsp;\u4ece\u6cd5\u89c4\u548c\u6280\u672f\u5c42\u9762\u5206\u6790\u7f8e\u56fdFDA\u5bf9\u5236\u836f\u4f01\u4e1a\u4ee5\u53ca\u836f\u5305\u6750\u4f01\u4e1a\u7684\u53d8\u66f4\u76d1\u7ba1\uff0c\u63a2\u8ba8\u5176\u4f18\u52bf\u548c\u5b58\u5728\u7684\u95ee\u9898\uff0c\u5bf9\u6bd4\u4e2d\u56fd\u4e0e\u7f8e\u56fd\u884c\u4e1a\u7684\u7279\u70b9\u3002<\/span><span style=\"max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7ed3\u679c\uff1a<\/strong>&nbsp;\u4e2d\u56fd\u4e0e\u7f8e\u56fd\u5728\u76d1\u7ba1\u7406\u5ff5\u548c\u6cd5\u89c4\u4e0a\u65e5\u6e10\u8d8b\u540c\uff0c\u4f46\u662f\u56fd\u5185\u836f\u5305\u6750\u4f01\u4e1a\u4e0e\u7f8e\u56fd\u5728\u89c4\u6a21\u548c\u7ba1\u7406\u4e0a\u8fd8\u5b58\u5728\u8f83\u5927\u5dee\u5f02\u3002<\/span><span style=\"max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7ed3\u8bba\uff1a<\/strong>&nbsp;\u836f\u5305\u6750\u53d8\u66f4\u662f\u836f\u54c1\u751f\u547d\u5468\u671f\u7ef4\u62a4\u7684\u7ec4\u6210\u90e8\u5206\uff0c\u884c\u4e1a\u76d1\u7ba1\u673a\u6784\u9700\u8981\u51fa\u5177\u76f8\u5e94\u7684\u53d8\u66f4\u6280\u672f\u6307\u5bfc\u539f\u5219\u4ee5\u53ca\u76f8\u5e94\u7684\u6cd5\u89c4\u8def\u5f84\u4f5c\u4e3a\u7814\u53d1\u4eba\u5458\u5bf9\u53d8\u66f4\u8bc4\u4f30\u7684\u91cd\u8981\u53c2\u8003\u4f9d\u636e\u3002<\/span><\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p><p style=\"margin-bottom: 15px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-weight: bold;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5173\u952e\u8bcd<\/span>\uff1a<\/span><span style=\"max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(29, 150, 232);border-bottom: 1px dotted rgb(29, 150, 232);cursor: pointer;box-sizing: border-box !important;word-wrap: break-word !important;\">\u53d8\u66f4<\/span>&nbsp;&nbsp;&nbsp;&nbsp;<span style=\"max-width: 100%;color: rgb(29, 150, 232);border-bottom: 1px dotted rgb(29, 150, 232);cursor: pointer;box-sizing: border-box !important;word-wrap: break-word !important;\">\u836f\u5305\u6750<\/span>&nbsp;&nbsp;&nbsp;&nbsp;<span style=\"max-width: 100%;color: rgb(29, 150, 232);border-bottom: 1px dotted rgb(29, 150, 232);cursor: pointer;box-sizing: border-box !important;word-wrap: break-word !important;\">\u53d8\u66f4\u6280\u672f\u6307\u5bfc\u539f\u5219<\/span>&nbsp;&nbsp;&nbsp;&nbsp;<span style=\"max-width: 100%;color: rgb(29, 150, 232);border-bottom: 1px dotted rgb(29, 150, 232);cursor: pointer;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<\/span>&nbsp;&nbsp;&nbsp;&nbsp;<span style=\"max-width: 100%;color: rgb(29, 150, 232);border-bottom: 1px dotted rgb(29, 150, 232);cursor: pointer;box-sizing: border-box !important;word-wrap: break-word !important;\">NMPA<\/span>&nbsp;&nbsp;&nbsp;&nbsp;<\/span><\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;\">Analysis and Discussion on Change Management of Pharmaceutical Packaging Materials<\/span><\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;\">Gao Yonghua<sup style=\"max-width: 100%;word-wrap: break-word;line-height: 0px;word-break: break-all;box-sizing: border-box !important;\"><img title=\"\u836f\u5305\u6750\u53d8\u66f4\u7ba1\u7406\u7684\u5206\u6790\u4e0e\u63a2\u8ba8\"     class=\"\" style=\"border-width: 0px;border-style: initial;border-color: initial;line-height: 0px;vertical-align: middle;word-break: break-all;overflow-wrap: break-word;box-sizing: border-box !important;word-wrap: break-word !important;width: 16px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/04\/6-1555470813.jpg\" alt=\"\u836f\u5305\u6750\u53d8\u66f4\u7ba1\u7406\u7684\u5206\u6790\u4e0e\u63a2\u8ba8\"  \/><\/sup>,&nbsp;Wu Zhiang<sup style=\"max-width: 100%;word-wrap: break-word;line-height: 0px;word-break: break-all;box-sizing: border-box !important;\"><img title=\"\u836f\u5305\u6750\u53d8\u66f4\u7ba1\u7406\u7684\u5206\u6790\u4e0e\u63a2\u8ba8\"     class=\"\" style=\"border-width: 0px;border-style: initial;border-color: initial;line-height: 0px;vertical-align: middle;cursor: pointer;word-break: break-all;overflow-wrap: break-word;box-sizing: border-box !important;word-wrap: break-word !important;width: 16px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/04\/3-1555470813.jpg\" alt=\"\u836f\u5305\u6750\u53d8\u66f4\u7ba1\u7406\u7684\u5206\u6790\u4e0e\u63a2\u8ba8\"  \/><\/sup><sup style=\"max-width: 100%;word-wrap: break-word;line-height: 0px;word-break: break-all;box-sizing: border-box !important;\"><img title=\"\u836f\u5305\u6750\u53d8\u66f4\u7ba1\u7406\u7684\u5206\u6790\u4e0e\u63a2\u8ba8\"     class=\"\" style=\"border-width: 0px;border-style: initial;border-color: initial;line-height: 0px;vertical-align: middle;word-break: break-all;overflow-wrap: break-word;box-sizing: border-box !important;word-wrap: break-word !important;width: 16px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/04\/1-1555470813.jpg\" alt=\"\u836f\u5305\u6750\u53d8\u66f4\u7ba1\u7406\u7684\u5206\u6790\u4e0e\u63a2\u8ba8\"  \/><\/sup>&nbsp;&nbsp;&nbsp;&nbsp;<\/span><\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Abstract<\/strong>:<\/span><span style=\"max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Objective:<\/strong>&nbsp;To summarize and analyze management regulations and methods for the change of pharmaceutical packaging materials in the United States and to provide references for the change management of pharmaceutical packaging materials after the implementation of the bounded review and approval in China so as to ensure drug safety, effectiveness and quality throughout drugs' life cycle.<strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Methods:<\/strong>&nbsp;The change management of pharmaceutical companies and pharmaceutical packaging material companies made by the US FDA were analyzed from the regulatory and technical aspects. The advantages and existing problems were discussed and the characteristics of the industries of China and US were compared.<strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Results:<\/strong>&nbsp;China and US have gradually reached agreement in terms of regulatory concepts and regulations, but there are large differences in scales and management between&nbsp;<\/span><span style=\"max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;\">pharmaceutical packaging material companies in two countries.<strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Conclusion:<\/strong>&nbsp;Changes of pharmaceutical packaging materials are an integral part of the maintenance for drugs' life cycle. Regulatory agencies need to issue corresponding technical guidelines for the change and regulatory paths as important references for R&amp;D people to assess change control.<\/span><\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p><p style=\"margin-bottom: 15px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-weight: bold;box-sizing: border-box !important;word-wrap: break-word !important;\">Keywords<\/span>:<\/span><span style=\"max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<span style=\"max-width: 100%;color: rgb(29, 150, 232);border-bottom: 1px dotted rgb(29, 150, 232);cursor: pointer;box-sizing: border-box !important;word-wrap: break-word !important;\">change<\/span>&nbsp;&nbsp;&nbsp;&nbsp;<span style=\"max-width: 100%;color: rgb(29, 150, 232);border-bottom: 1px dotted rgb(29, 150, 232);cursor: pointer;box-sizing: border-box !important;word-wrap: break-word !important;\">pharmaceutical packaging materials<\/span>&nbsp;&nbsp;&nbsp;&nbsp;<span style=\"max-width: 100%;color: rgb(29, 150, 232);border-bottom: 1px dotted rgb(29, 150, 232);cursor: pointer;box-sizing: border-box !important;word-wrap: break-word !important;\">technical guidelines for the change<\/span>&nbsp;&nbsp;&nbsp;&nbsp;<span style=\"max-width: 100%;color: rgb(29, 150, 232);border-bottom: 1px dotted rgb(29, 150, 232);cursor: pointer;box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<\/span>&nbsp;&nbsp;&nbsp;&nbsp;<span style=\"max-width: 100%;color: rgb(29, 150, 232);border-bottom: 1px dotted rgb(29, 150, 232);cursor: pointer;box-sizing: border-box !important;word-wrap: break-word !important;\">NMPA<\/span>&nbsp;&nbsp;&nbsp;&nbsp;<\/span><\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u5728\u836f\u5305\u6750\u5b9e\u9645\u751f\u4ea7\u548c\u4f7f\u7528\u8fc7\u7a0b\u4e2d\uff0c\u53d8\u66f4\u4f1a\u65f6\u5e38\u53d1\u751f\uff0c\u6709\u836f\u5305\u6750\u767b\u8bb0\u4eba\u4e3b\u52a8\u8fdb\u884c\u7684\u8d28\u91cf\u63d0\u5347\u548c\u6539\u9020\uff0c\u4e5f\u6709\u53d7\u7a81\u53d1\u6216\u4e0d\u53ef\u63a7\u539f\u56e0\u5bfc\u81f4\u7684\u53d8\u66f4\u3002\u53d8\u66f4\u5185\u5bb9\u6d89\u53ca\u4ece\u539f\u8f85\u6750\u6599\u5230\u751f\u4ea7\u5de5\u827a\u5404\u4e2a\u65b9\u9762\u3002\u56e0\u6b64\uff0c\u53d8\u66f4\u7814\u7a76\u5bf9\u4e8e\u836f\u5305\u6750\u884c\u4e1a\u6765\u8bf4\u662f\u5f88\u91cd\u8981\u7684\u95ee\u9898\uff0c\u76f4\u63a5\u5f71\u54cd\u5230\u4ea7\u54c1\u8d28\u91cf\uff0c\u5e76\u5f71\u54cd\u5230\u836f\u54c1\u7684\u5b89\u5168\u6709\u6548\u3002\u53d8\u66f4\u7814\u7a76\u8d2f\u7a7f\u4e8e\u6574\u4e2a\u4ea7\u54c1\u751f\u547d\u5468\u671f<sup style=\"max-width: 100%;word-wrap: break-word;line-height: 0px;word-break: break-all;box-sizing: border-box !important;\">[<span style=\"max-width: 100%;word-wrap: break-word;line-height: 0px;word-break: break-all;box-sizing: border-box !important;\">1<\/span>-<span style=\"max-width: 100%;word-wrap: break-word;line-height: 0px;word-break: break-all;box-sizing: border-box !important;\">2<\/span>]<\/sup>\u3002\u76ee\u524d\uff0c\u56fd\u5185\u836f\u54c1\u3001\u836f\u5305\u6750\u4ee5\u53ca\u836f\u7528\u8f85\u6599\u7684\u76f8\u5173\u6cd5\u89c4\u548c\u8981\u6c42\u5c42\u51fa\u4e0d\u7a77\uff0c\u5176\u4e2d\u5173\u4e8e\u836f\u5305\u6750\u7684\u53d8\u66f4\u7814\u7a76\u5728\u884c\u4e1a\u5185\u5df2\u6709\u5f81\u6c42\u610f\u89c1\u7a3f\u3002\u672c\u6587\u5c31\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u5bf9\u4e8e\u836f\u5305\u6750\u53d8\u66f4\u7ba1\u7406\u7684\u8981\u6c42\u548c\u6cd5\u89c4\u9014\u5f84\u8fdb\u884c\u4f18\u52a3\u5206\u6790\uff0c\u8fdb\u800c\u4e3a\u6211\u56fd\u5904\u4e8e\u6cd5\u89c4\u6539\u9769\u9636\u6bb5\u7684\u836f\u5305\u6750\u76d1\u7ba1\u63d0\u4f9b\u501f\u9274\u548c\u5e2e\u52a9\u3002<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span level=\"1\" style=\"padding-top: 3px;padding-bottom: 3px;max-width: 100%;display: block;font-weight: bold;font-size: 18px;line-height: 25px;text-indent: 0em;background-color: rgb(225, 225, 225);box-sizing: border-box !important;word-wrap: break-word !important;\">1 FDA\u5bf9\u4e8e\u836f\u5305\u6750\u7684\u76d1\u7ba1\u6a21\u5f0f\u53ca\u5176\u8d28\u91cf\u6807\u51c6\u8981\u6c42<\/span><\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">FDA\u7684\u76d1\u7ba1\u4e3b\u8981\u9488\u5bf9\u836f\u54c1\uff0c\u800c\u5bf9\u4e8e\u836f\u54c1\u76f8\u5173\u7684\u201c\u9644\u5c5e\u201d\u4ea7\u54c1\u5982\u539f\u6599\u836f\u3001\u836f\u7528\u8f85\u6599\u548c\u836f\u5305\u6750\u5219\u91c7\u53d6\u7ed3\u5408\u836f\u54c1\u7684\u5173\u8054\u5ba1\u8bc4\u65b9\u5f0f\uff0c\u5bf9\u4e8e\u8fd9\u4e9b\u4ea7\u54c1\u7684\u76d1\u7ba1\uff0c\u4e3b\u8981\u7531\u836f\u54c1\u751f\u4ea7\u5546\u6765\u8d1f\u8d23\u3002\u4f46\u662f\u8003\u8651\u5230\u8fd9\u4e9b\u4ea7\u54c1\u672c\u8eab\u6240\u62e5\u6709\u7684\u77e5\u8bc6\u4ea7\u6743\u4e0d\u53ef\u80fd\u6cc4\u9732\u7ed9\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\uff0c\u540c\u65f6\u7ed3\u5408FDA\u4e3b\u8981\u9488\u5bf9\u836f\u54c1\u7684\u76d1\u7ba1\u6a21\u5f0f\uff0cFDA\u63a8\u51fa\u4e86\u836f\u54c1\u4e3b\u63a7\u6587\u4ef6\uff08Drug&nbsp;Master&nbsp;File\uff0cDMF\uff09\u7684\u7ba1\u7406\u6a21\u5f0f\u3002\u6309\u7167\u4e0d\u540c\u7684\u4ea7\u54c1\u5907\u6848\u5206\u7c7b\uff0cDMF\u5206\u4e3a5\u7c7b\uff1a<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u2160\u7c7b\uff1a\u751f\u4ea7\u5730\u70b9\u3001\u8bbe\u65bd\u3001\u64cd\u4f5c\u6d41\u7a0b\u548c\u4eba\u5458\uff08\u5df2\u53d6\u6d88\uff09\uff1b<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u2161\u7c7b\uff1a\u539f\u6599\u836f\u3001\u4e2d\u95f4\u4f53\u53ca\u5176\u5236\u5907\u4e2d\u6240\u7528\u6750\u6599\u6216\u836f\u54c1\uff1b<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u2162\u7c7b\uff1a\u5305\u88c5\u6750\u6599\uff1b<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u2163\u7c7b\uff1a\u8d4b\u5f62\u5242\u3001\u7740\u8272\u5242\u3001\u77eb\u5473\u5242\u3001\u9999\u7cbe\u6216\u4ee5\u4e0a\u5236\u5907\u4e2d\u6240\u7528\u6750\u6599\uff1b<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u2164\u7c7b\uff1aFDA\u63a5\u53d7\u7684\u5176\u4ed6\u53c2\u8003\u4fe1\u606f<sup style=\"max-width: 100%;word-wrap: break-word;line-height: 0px;word-break: break-all;box-sizing: border-box !important;\">[<span style=\"max-width: 100%;word-wrap: break-word;line-height: 0px;word-break: break-all;box-sizing: border-box !important;\">3<\/span>]<\/sup>\u3002<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u9488\u5bf9\u4e0d\u540c\u7c7b\u578bDMF\u6709\u4e0d\u540c\u7684\u8d44\u6599\u8981\u6c42\uff0c\u6240\u6709\u836f\u5305\u6750\uff0c\u5305\u62ec\u8fdb\u53e3\u836f\u5305\u6750\u4ee5\u53ca\u7f8e\u56fd\u672c\u571f\u751f\u4ea7\u7684\u836f\u5305\u6750\uff0c\u90fd\u53ef\u4ee5\u7533\u8bf7\u2162\u7c7bDMF\u5907\u6848\u3002\u6309\u7167\u901a\u7528\u6280\u672f\u6587\u4ef6\u683c\u5f0f\u8981\u6c42\u64b0\u5199\u8d44\u6599\uff0c\u5f62\u6210\u5b8c\u6574\u7684DMF\u6587\u4ef6\u540e\u4ee5\u7535\u5b50\u9012\u4ea4\u7684\u65b9\u5f0f\u9012\u4ea4DMF\u5907\u6848\u3002FDA\u5728\u6536\u5230\u5907\u6848\u8d44\u6599\u540e2~3\u5468\u5185\uff0c\u5bf9\u8d44\u6599\u8fdb\u884c\u5f62\u5f0f\u6838\u67e5\uff0c\u4e3b\u8981\u5173\u6ce8\u901a\u7528\u6280\u672f\u6587\u4ef6\u6240\u6709\u90e8\u5206\u90fd\u6709\u76f8\u5e94\u7684\u5185\u5bb9\uff0c\u4f46\u662f\u4e0d\u4f1a\u5173\u6ce8\u5177\u4f53\u6280\u672f\u6570\u636e\u3002\u5f62\u5f0f\u6838\u67e5\u901a\u8fc7\u540e\uff0cFDA\u4f1a\u516c\u5e03DMF\u53f7\uff0c\u4e8e\u662f\u76f8\u5e94\u7684\u836f\u5305\u6750\u62e5\u6709\u4e86\u81ea\u5df1\u7684DMF\u5907\u6848\u53f7\u3002\u5f53\u8be5\u836f\u5305\u6750\u7528\u4e8e\u5305\u88c5\u67d0\u4e2a\u836f\u54c1\u65f6\uff0c\u8be5\u836f\u54c1\u6ce8\u518c\u7533\u8bf7\u4eba\u5411FDA\u9012\u4ea4\u6ce8\u518c\u7533\u8bf7\uff0cFDA\u5bf9\u836f\u54c1\u8fdb\u884c\u6280\u672f\u5ba1\u8bc4\u65f6\uff0c\u4f1a\u5173\u8054\u76f8\u5e94\u5305\u6750\u7684\u8d44\u6599\u8fdb\u884c\u5ba1\u8bc4\uff0c\u8fd9\u79cd\u5ba1\u8bc4\u6a21\u5f0f\u88ab\u79f0\u4e3a\u5173\u8054\u5ba1\u8bc4\u3002\u5728\u5ba1\u8bc4\u5b8c\u6210\u540e\uff0c\u836f\u54c1\u7533\u8bf7\u4eba\u4f1a\u88ab\u901a\u77e5\u901a\u8fc7\u5ba1\u8bc4\uff0c\u800c\u5305\u6750DMF\u53f7\u4f1a\u8bf4\u660e\u901a\u8fc7\u6280\u672f\u5ba1\u8bc4\u3002\u4e0a\u8ff0\u6d41\u7a0b\u5c31\u662fDMF\u5907\u6848\u4ee5\u53ca\u5173\u8054\u5ba1\u8bc4\u5236\u5ea6\u3002\u7531\u4e8eDMF\u5236\u5ea6\u6210\u7acb\uff0c\u5176\u521d\u8877\u662f\u4e3a\u4e86\u4fdd\u62a4\u77e5\u8bc6\u4ea7\u6743\uff0c\u9632\u6b62DMF\u6301\u6709\u4eba\uff08\u4f8b\u5982\u5305\u6750\uff09\u7684\u6280\u672f\u4fe1\u606f\u6cc4\u9732\u7ed9\u836f\u54c1\u7533\u8bf7\u4eba\uff0c\u56e0\u6b64\uff0cDMF\u5907\u6848\u5236\u5ea6\u4e0d\u662f\u5f3a\u5236\u8981\u6c42\u3002\u800c\u662f\u5426\u7533\u8bf7DMF\u5b8c\u5168\u7531\u7533\u8bf7\u4eba\u81ea\u5df1\u51b3\u5b9a\uff0cFDA\u5bf9\u6b64\u4fdd\u6301\u4e0d\u53cd\u5bf9\u4e5f\u4e0d\u9f13\u52b1\u7684\u4e2d\u7acb\u6001\u5ea6\u3002<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u5728\u6280\u672f\u65b9\u9762\uff0c\u76ee\u524d\u7f8e\u56fd\u836f\u54c1\u884c\u4e1a\u5173\u4e8e\u836f\u5305\u6750\u6807\u51c6\u7684\u8981\u6c42\uff0c\u4e3b\u8981\u662f\u7f8e\u56fd\u836f\u5178\u7684\u836f\u5305\u6750\u4e13\u8bba\u7ae0\u8282\u3002\u4f46\u662f\uff0c\u5bf9\u4e8e\u7f8e\u56fd\u836f\u5178\u7684\u8981\u6c42\u4ec5\u4ec5\u662f\u53c2\u8003\u6807\u51c6\uff0c\u4e5f\u975e\u5f3a\u5236\u8981\u6c42\u3002\u5982\u679c\u836f\u5305\u6750\u751f\u4ea7\u4f01\u4e1a\u6709\u8db3\u591f\u7684\u79d1\u5b66\u7814\u7a76\u6570\u636e\uff0c\u8bc1\u660e\u7f8e\u56fd\u836f\u5178\u76f8\u5e94\u68c0\u6d4b\u6807\u51c6\u6216\u8005\u68c0\u6d4b\u65b9\u6cd5\u4e0d\u9002\u7528\u4e8e\u67d0\u4e9b\u836f\u5305\u6750\uff0c\u4f46\u662f\u5bf9\u836f\u54c1\u4e0d\u4ea7\u751f\u4e0d\u826f\u5f71\u54cd\uff0cFDA\u5728\u5173\u8054\u5ba1\u8bc4\u8fc7\u7a0b\u4e2d\u4e5f\u4f1a\u63a5\u53d7\u6b64\u7c7b\u6807\u51c6\u3002<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u53e6\u5916\uff0c\u5982\u540c\u5173\u8054\u5ba1\u8bc4\u4e00\u6837\uff0c\u7531\u4e8eFDA\u610f\u8bc6\u5230\u5355\u72ec\u7814\u7a76\u836f\u5305\u6750\u672c\u8eab\u610f\u4e49\u4e0d\u5927\uff0c\u9700\u8981\u548c\u76f8\u5173\u7684\u836f\u54c1\u7ed3\u5408\u7814\u7a76\uff0c\u8003\u8651\u836f\u5305\u6750\u9488\u5bf9\u7279\u5b9a\u836f\u54c1\u7684\u9002\u7528\u6027\uff0c\u5305\u62ec\u836f\u5305\u6750\u7684\u4fdd\u62a4\u6027\u3001\u5b89\u5168\u6027\u3001\u76f8\u5bb9\u6027\u3001\u529f\u80fd\u6027\u7b49\u3002\u56e0\u6b64\uff0c\u5728\u6280\u672f\u5ba1\u8bc4\u8fc7\u7a0b\u4e2d\uff0c\u4e5f\u66f4\u591a\u5173\u6ce8\u836f\u54c1\u5728\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u5bf9\u76f8\u5e94\u836f\u5305\u6750\u7684\u7814\u7a76\u9879\u76ee\u548c\u7814\u7a76\u5185\u5bb9\uff0c\u5e76\u4e14\u7814\u7a76\u7ed3\u679c\u662f\u5426\u53ef\u4ee5\u8bf4\u660e\u836f\u5305\u6750\u5bf9\u836f\u54c1\u7684\u9002\u7528\u6027\u3002\u540c\u65f6\uff0c\u8003\u8651\u5230\u4e0d\u540c\u7684\u836f\u54c1\uff0c\u7531\u4e8e\u7ed9\u836f\u9014\u5f84\u4ee5\u53ca\u4f5c\u7528\u539f\u7406\u4e0d\u540c\uff0c\u5176\u98ce\u9669\u4e5f\u6709\u9ad8\u4f4e\u4e4b\u5206\uff0c\u56e0\u6b64FDA\u9488\u5bf9\u4e0d\u540c\u98ce\u9669\u5206\u7ea7\u7684\u7ed9\u836f\u65b9\u5f0f\uff0c\u7ed9\u836f\u5305\u6750\u51fa\u5177\u76f8\u5e94\u7684\u6280\u672f\u5ba1\u8bc4\u6307\u5bfc\u539f\u5219\uff0c\u5373CMC&nbsp;Reviews&nbsp;of&nbsp;Type&nbsp;\u2162&nbsp;DMFs&nbsp;for&nbsp;Packaging&nbsp;Materials&nbsp;MAPP&nbsp;5015.5&nbsp;Rev.&nbsp;1<sup style=\"max-width: 100%;word-wrap: break-word;line-height: 0px;word-break: break-all;box-sizing: border-box !important;\">[<span style=\"max-width: 100%;word-wrap: break-word;line-height: 0px;word-break: break-all;box-sizing: border-box !important;\">4<\/span>]<\/sup>\uff0c\u4ee5\u4fbf\u5728\u5305\u6750\u751f\u4ea7\u4f01\u4e1a\u5f00\u53d1\u4ea7\u54c1\u4ee5\u53ca\u64b0\u5199DMF\u5907\u6848\u8d44\u6599\u65f6\u6709\u66f4\u79d1\u5b66\u7684\u4f9d\u636e\uff0c\u4e5f\u66f4\u4e3a\u4e86\u89e3FDA\u5ba1\u8bc4\u5458\u7684\u5173\u6ce8\u70b9\u3002<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u7efc\u4e0a\u6240\u8ff0\uff0c\u53ef\u4ee5\u4ece\u4e24\u4e2a\u65b9\u9762\u7406\u89e3FDA\u5bf9\u4e8e\u6574\u4e2a\u836f\u5305\u6750\u884c\u4e1a\u7684\u76d1\u7ba1\uff1a<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">1\uff09\u4ece\u6cd5\u89c4\u7ba1\u7406\u5c42\u9762\uff0cFDA\u5bf9\u4e8e\u836f\u5305\u6750\u7684\u7ba1\u7406\uff0c\u5176\u5b9e\u662f\u201c\u59d4\u6258\u201d\u76f8\u5173\u7684\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u3002\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u4f5c\u4e3a\u7b2c\u4e00\u8d23\u4efb\u4eba\uff0c\u5bf9\u6240\u6709\u548c\u836f\u54c1\u76f8\u5173\u7684\u4e8b\u6545\u8d23\u4efb\u8d1f\u8d23\uff0c\u5373\u4f7f\u67d0\u4e9b\u95ee\u9898\u6765\u6e90\u4e8e\u836f\u5305\u6750\u3001\u836f\u7528\u8f85\u6599\u6216\u8005\u539f\u6599\u836f\u3002<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">2\uff09\u4ece\u6280\u672f\u6307\u5bfc\u5c42\u9762\uff0cFDA\u548c\u7f8e\u56fd\u836f\u5178\u59d4\u5458\u4f1a\u4e00\u8d77\u63d0\u4f9b\u76f8\u5173\u7684\u836f\u5178\u6807\u51c6\uff0c\u5e76\u4e14FDA\u4e5f\u7ed9\u51fa\u76f8\u5e94\u7684\u5ba1\u8bc4\u6307\u5bfc\u539f\u5219\uff0c\u4f7f\u836f\u5305\u6750\u4f01\u4e1a\u5305\u62ec\u5236\u836f\u4f01\u4e1a\u6709\u660e\u786e\u7684\u6280\u672f\u6307\u5bfc\u539f\u5219\u53ef\u4ee5\u53c2\u8003\u3002<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u56e0\u6b64\uff0cFDA\u5728\u5bf9\u4e8e\u836f\u5305\u6750\u7684\u6574\u4f53\u76d1\u7ba1\u53ef\u4ee5\u7406\u89e3\u4e3a\uff0c\u836f\u54c1\u4e3a\u4e3b\u529b\uff0cFDA\u63d0\u4f9b\u652f\u6301\u3002<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><mpcpc js_editor_cpcad=\"\" class=\"js_cpc_area res_iframe cpc_iframe\" src=\"\/cgi-bin\/readtemplate?t=tmpl\/cpc_tmpl#1555163374275\" data-category_id_list=\"1|11|15|16|17|22|24|26|27|28|3|31|32|35|36|37|39|40|41|42|43|44|45|46|47|48|5|6|7|8\" ><\/mpcpc><\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span level=\"1\" style=\"padding-top: 3px;padding-bottom: 3px;max-width: 100%;display: block;font-weight: bold;font-size: 18px;line-height: 25px;text-indent: 0em;background-color: rgb(225, 225, 225);box-sizing: border-box !important;word-wrap: break-word !important;\">2 FDA\u5bf9\u4e8e\u836f\u5305\u6750\u53d8\u66f4\u7ba1\u7406\u7684\u4f18\u52bf\u548c\u95ee\u9898\u5206\u6790<\/span><\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u4ea7\u54c1\u4e0a\u5e02\u540e\u53d8\u66f4\u662f\u5e38\u6001\uff0cFDA\u5bf9\u4e8e\u4ea7\u54c1\u7684\u53d8\u66f4\u6709\u6bd4\u8f83\u591a\u7684\u6280\u672f\u6307\u5bfc\u539f\u5219\u3002FDA\u7684\u76d1\u7ba1\u4e3b\u6293\u836f\u54c1\uff0c\u56e0\u6b64\u53d8\u66f4\u7684\u6307\u5bfc\u539f\u5219\u51e0\u4e4e\u5168\u90e8\u662f\u5173\u4e8e\u836f\u54c1\u7684\uff0c\u800c\u5bf9\u4e8e\u836f\u5305\u6750\u7684\u53d8\u66f4\uff0c\u4e5f\u662f\u8bc4\u4f30\u5305\u6750\u7684\u53d8\u66f4\u5bf9\u4e8e\u836f\u54c1\u7684\u5f71\u54cd\u3002\u5728\u8fd9\u4e9b\u6307\u5bfc\u539f\u5219\u4e2d\uff0c\u6bd4\u8f83\u5173\u952e\u4e5f\u662f\u6700\u4e3a\u5e38\u89c1\u7684\u662f\u201cChanges&nbsp;to&nbsp;an&nbsp;Approved&nbsp;NDA&nbsp;and&nbsp;ANDA\u201d&nbsp;<sup style=\"max-width: 100%;word-wrap: break-word;line-height: 0px;word-break: break-all;box-sizing: border-box !important;\">[<span style=\"max-width: 100%;word-wrap: break-word;line-height: 0px;word-break: break-all;box-sizing: border-box !important;\">5<\/span>]<\/sup>\u4ee5\u53ca\u201cANDA Submissions-Prior Approval Supplements Under GDUFA\u201d&nbsp;<sup style=\"max-width: 100%;word-wrap: break-word;line-height: 0px;word-break: break-all;box-sizing: border-box !important;\">[<span style=\"max-width: 100%;word-wrap: break-word;line-height: 0px;word-break: break-all;box-sizing: border-box !important;\">6<\/span>]<\/sup>\u548c\u201cScale-up and post-approval changes\u201d&nbsp;<sup style=\"max-width: 100%;word-wrap: break-word;line-height: 0px;word-break: break-all;box-sizing: border-box !important;\">[<span style=\"max-width: 100%;word-wrap: break-word;line-height: 0px;word-break: break-all;box-sizing: border-box !important;\">7<\/span>]<\/sup>\u3002<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u76f8\u6bd4\u4e8e\u6b27\u6d32\u836f\u76d1\u5c40\uff08European&nbsp;Medicine&nbsp;Agency\uff0cEMA\uff09\uff0cFDA\u7684\u53d8\u66f4\u6280\u672f\u6307\u5bfc\u539f\u5219\u5206\u7c7b\u6bd4\u8f83\u7b80\u660e\u627c\u8981\uff0c\u57fa\u4e8e\u53d8\u66f4\u5bf9\u4ea7\u54c1\u7684\u7279\u6027\u3001\u89c4\u683c\u3001\u8d28\u91cf\u3001\u6548\u4ef7\u4ee5\u53ca\u5176\u4ed6\u548c\u4ea7\u54c1\u5b89\u5168\u3001\u6709\u6548\u6027\u76f8\u5173\u7684\u56e0\u7d20\u6f5c\u5728\u7684\u5f71\u54cd\u7a0b\u5ea6\uff0c\u5c06\u53d8\u66f4\u5206\u6210\u4e09\u5927\u7c7b\uff1a\u5fae\u5c0f\u53d8\u66f4\u3001\u4e2d\u7b49\u53d8\u66f4\u548c\u91cd\u5927\u53d8\u66f4\u3002\u5404\u7c7b\u53d8\u66f4\u6709\u5404\u81ea\u6e05\u6670\u7684\u6cd5\u89c4\u7533\u62a5\u9014\u5f84\u3002\u5bf9\u4e8e\u5fae\u5c0f\u53d8\u66f4\uff0c\u53ef\u4ee5\u901a\u8fc7\u5e74\u62a5\uff08Annual&nbsp;Report\uff09\u5f62\u5f0f\u901a\u77e5\u76d1\u7ba1\u673a\u6784\u3002\u5bf9\u4e8e\u4e2d\u7b49\u53d8\u66f4\uff0c\u6839\u636e\u4e2d\u7b49\u53d8\u66f4\u7684\u672c\u8eab\u6027\u8d28\u4e0d\u540c\uff0c\u4e5f\u6709\u4e24\u7c7b\u7533\u62a5\u9014\u5f84\uff1a\u7acb\u5373\u6267\u884c\u7684\u8865\u5145\u7533\u8bf7\uff08Supplement-Changes&nbsp;Being&nbsp;Effected\uff0cCBE-0\uff09\uff0c\u4ee5\u53ca30\u5929\u540e\u6267\u884c\u7684\u8865\u5145\u7533\u8bf7\uff08Supplement&nbsp;-&nbsp;Changes&nbsp;Being&nbsp;Effected&nbsp;in&nbsp;30&nbsp;Days\uff0cCBE-30\uff09\uff1b\u524d\u8005\u610f\u5473\u7740\u7533\u8bf7\u4eba\u5728\u5c06\u53d8\u66f4\u9012\u4ea4\u81f3FDA\u540e\u53ef\u4ee5\u7acb\u523b\u6267\u884c\u53d8\u66f4\uff0c\u800c\u540e\u8005\u5219\u9700\u8981\u5728\u53d8\u66f4\u7533\u62a5\u9012\u4ea4\u81f3FDA\u540e\u7b49\u501930\u5929\uff0c\u5982\u679c30\u5929\u5185\u6ca1\u6709\u5f97\u5230FDA\u7684\u901a\u77e5\uff0c\u5219\u53ef\u4ee5\u6267\u884c\u53d8\u66f4\uff08\u4e00\u822c\u6765\u8bf4\uff0c\u7533\u8bf7\u4eba\u4f1a\u572830\u5929\u5185\u4e0eFDA\u5ba1\u8bc4\u7684\u9879\u76ee\u8d1f\u8d23\u4eba\u4fdd\u6301\u8054\u7cfb\uff0c\u4ee5\u786e\u4fdd\u53d8\u66f4\u7533\u62a5\u5728FDA\u5ba1\u8bc4\u8fdb\u5c55\u987a\u5229\uff09\u3002\u5bf9\u4e8e\u91cd\u5927\u53d8\u66f4\uff0c\u7533\u8bf7\u4eba\u9700\u8981\u9012\u4ea4\u8865\u5145\u7533\u8bf7\u7ed9FDA\u5ba1\u8bc4\u5ba1\u6279\uff0c\u6279\u51c6\u540e\uff0c\u624d\u80fd\u6267\u884c\u53d8\u66f4\uff08Prior&nbsp;Approval&nbsp;Supplement\uff0cPAS\uff09\u3002<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">FDA\u7684\u53d8\u66f4\u5206\u7c7b\u539f\u5219\uff0c\u662f\u57fa\u4e8e\u53d8\u66f4\u672c\u8eab\u5bf9\u4e8e\u4ea7\u54c1\u8d28\u91cf\u5f71\u54cd\u7684\u7a0b\u5ea6\u3002\u5f53\u53d8\u66f4\u53d1\u751f\u65f6\uff0c\u9700\u8981\u5bf9\u4ea7\u54c1\u672c\u8eab\u5b89\u5168\u3001\u4e34\u5e8a\u6548\u7528\u4ee5\u53ca\u8d28\u91cf\u53ef\u63a7\u8fdb\u884c\u5408\u7406\u8bc4\u4f30\uff0c\u7136\u540e\u5728\u8fdb\u884c\u76f8\u5e94\u7684\u7814\u7a76\u9a8c\u8bc1\u5de5\u4f5c\u3002\u5f53\u7136\uff0c\u5728\u53d8\u66f4\u6280\u672f\u6307\u5bfc\u539f\u5219\u4e2d\uff0cFDA\u4e5f\u9610\u8ff0\u4e86\u5404\u7c7b\u6279\u51c6\u540e\u7684\u4ea7\u54c1\u5728\u751f\u4ea7\u573a\u5730\u3001\u751f\u4ea7\u5de5\u827a\u3001\u5904\u65b9\u3001\u6807\u51c6\u3001\u5305\u88c5\u5bb9\u5668\u7cfb\u7edf\uff0c\u4ee5\u53ca\u8bf4\u660e\u4e66\u548c\u5305\u88c5\u6807\u7b7e\u53d1\u751f\u5355\u4e2a\u53d8\u66f4\u4ee5\u53ca\u591a\u4e2a\u53d8\u66f4\u540c\u65f6\u53d1\u751f\u65f6\uff0c\u5982\u4f55\u505a\u51fa\u53d8\u66f4\u5206\u7c7b\u8bc4\u4f30\uff1b\u540c\u65f6\uff0c\u9488\u5bf9\u4e0a\u8ff0\u5404\u7c7b\u4e0d\u540c\u53d8\u66f4\u53d1\u751f\u65f6\uff0c\u7ed9\u51fa\u5404\u79cd\u5177\u4f53\u5b9e\u4f8b\u53ca\u5176\u6240\u5c5e\u53d8\u66f4\u79cd\u7c7b\u3002\u4f46\u662f\u7531\u4e8e\u5728\u6574\u4e2a\u4ea7\u54c1\u751f\u547d\u5468\u671f\u5185\uff0c\u53d1\u751f\u7684\u53d8\u66f4\u975e\u5e38\u591a\uff0c\u8fdc\u8fdc\u8d85\u51faFDA\u53d8\u66f4\u6280\u672f\u6307\u5bfc\u539f\u5219\u4e2d\u4e3e\u4f8b\u7684\u60c5\u51b5\uff0c\u56e0\u6b64\uff0c\u5f88\u591a\u672a\u7eb3\u5165\u4e0a\u8ff0\u53d8\u66f4\u6280\u672f\u6307\u5bfc\u539f\u5219\u7684\u53d8\u66f4\u5206\u7c7b\uff0c\u9700\u8981\u7533\u8bf7\u4eba\u6839\u636e\u4ea7\u54c1\u7279\u6027\u548c\u53d8\u66f4\u7279\u6027\u505a\u597d\u8bc4\u4f30\u3002\u53ef\u4ee5\u7406\u89e3\u4e3a\uff0cFDA\u66f4\u591a\u662f\u8981\u6c42\u7533\u8bf7\u4eba\u81ea\u8eab\u5bf9\u4e8e\u53d8\u66f4\u505a\u597d\u8bc4\u4f30\uff0c\u5e76\u4e14\u5b8c\u6210\u76f8\u5e94\u7684\u7814\u7a76\u9a8c\u8bc1\u5de5\u4f5c\u3002\u53e6\u5916\uff0c\u5bf9\u4e8e\u76f8\u5e94\u9700\u8981\u5b8c\u6210\u7684\u5177\u4f53\u9a8c\u8bc1\u7814\u7a76\u5de5\u4f5c\uff0c\u4ee5\u53ca\u9700\u8981\u7533\u62a5\u9012\u4ea4\u7684\u8d44\u6599\uff0cFDA\u5e76\u6ca1\u6709\u548cEMA\u4e00\u6837\u7ed9\u51fa\u8be6\u7ec6\u7684\u8981\u6c42\u4ee5\u53ca\u6240\u6709\u53d8\u66f4\u5fc5\u987b\u7b26\u5408\u7684\u524d\u63d0\u6761\u4ef6\u3002FDA\u5b8c\u5168\u5c06\u53d8\u66f4\u8bc4\u4f30\u548c\u7533\u62a5\u7684\u4e3b\u52a8\u6743\u4ea4\u7ed9\u7533\u8bf7\u4eba\u3002<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">FDA\u4ee5\u8fd9\u79cd\u6a21\u5f0f\u7ba1\u7406\u836f\u54c1\u3001\u836f\u5305\u6750\u8fd8\u6709\u836f\u7528\u8f85\u6599\u7684\u53d8\u66f4\uff0c\u5bf9\u6574\u4e2a\u884c\u4e1a\u81f3\u5c11\u6709\u4e24\u70b9\u76ca\u5904\uff1a<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u7b2c\u4e00\uff0cFDA\u7684\u53d8\u66f4\u6280\u672f\u6307\u5bfc\u539f\u5219\u5b8c\u5168\u57fa\u4e8e\u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1\uff08Quality&nbsp;by&nbsp;Design\uff09\uff0c\u5373QbD\u7406\u5ff5\u3002FDA\u4e8e2006\u5e74\u63d0\u51faQbD\uff0c\u7b80\u5355\u6765\u8bf4\u5c31\u662f\u4ea7\u54c1\uff08\u836f\u54c1\u3001\u5305\u6750\u548c\u8f85\u6599\uff09\u5728\u8bbe\u8ba1\u4e4b\u521d\uff0c\u5fc5\u987b\u8003\u8651\u5230\u5c06\u6765\u4f7f\u7528\u4ea7\u54c1\u7684\u5bf9\u8c61\uff0c\u4ece\u5bf9\u8c61\u7684\u9700\u6c42\u5373\u7ec8\u7aef\u7528\u6237\u7684\u9700\u6c42\u51fa\u53d1\uff0c\u8bbe\u8ba1\u5f00\u53d1\u4ea7\u54c1\u672c\u8eab\uff0c\u786e\u5b9a\u4ea7\u54c1\u7684\u76ee\u6807\u4ea7\u54c1\u8d28\u91cf\u6982\u51b5\uff08Quality&nbsp;Target&nbsp;Product&nbsp;Profile\uff0cQTPP\uff09\u5e76\u4e14\u6846\u5b9a\u8be5\u4ea7\u54c1\u7684\u8bbe\u8ba1\u7a7a\u95f4\uff08Design&nbsp;Space\uff0cDS\uff09\uff0c\u8fdb\u800c\u63a8\u5bfc\u51fa\u4ea7\u54c1\u5e38\u89c4\u4ee5\u53ca\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff08Critical&nbsp;Quality&nbsp;Attributes\uff0cCQA\uff09\uff0c\u636e\u6b64\u53ef\u4ee5\u786e\u5b9a\u4ea7\u54c1\u7684\u751f\u4ea7\u5de5\u827a\u3001\u5173\u952e\u5de5\u827a\u6b65\u9aa4\u3001\u5173\u952e\u5de5\u827a\u53c2\u6570\uff08Critical&nbsp;Process&nbsp;Parameters\uff0cCPP\uff09\uff0c\u4ee5\u53ca\u5bf9\u4ea7\u54c1\u6709\u5f71\u54cd\u7684\u5173\u952e\u7269\u6599\u5c5e\u6027\uff08Critical&nbsp;Materials&nbsp;Attributes\uff0cCMA\uff09\u2026\u2026\u5728\u4ea7\u54c1\u88abFDA\u6279\u51c6\u540e\uff0c\u5982\u679c\u6709\u76f8\u5e94\u7684\u53d8\u66f4\uff0c\u5219\u901a\u8fc7\u8bc4\u4f30\u8fd9\u4e9b\u53d8\u66f4\u5bf9CQA\u4ee5\u53caDS\u7684\u5f71\u54cd\uff0c\u6765\u5224\u65ad\u53d8\u66f4\u7684\u5206\u7ea7\u3002\u5f53\u7136\uff0c\u8fd9\u4e9b\u53c2\u6570\u4e5f\u662f\u6307\u5bfc\u4ea7\u54c1\u5728\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u7684\u6cd5\u89c4\u7b26\u5408\u6027\uff0c\u5982\u679c\u5728\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u67d0\u4e9b\u53c2\u6570\u8d85\u51faCQA\u4ee5\u53caDS\u7684\u8303\u7574\uff0c\u5373\u4f7f\u6700\u540e\u4ea7\u54c1\u68c0\u9a8c\u5408\u683c\uff0c\u4e5f\u4e0d\u5f97\u4e0a\u5e02\u9500\u552e\u3002<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u7b2c\u4e8c\uff0cFDA\u7684\u53d8\u66f4\u6280\u672f\u6307\u5bfc\u539f\u5219\u662f\u57fa\u4e8e\u4ea7\u54c1\u751f\u547d\u5468\u671f\u7684\u7ef4\u62a4\u800c\u5efa\u7acb\uff0c\u5e76\u4e14\u540c\u65f6\u660e\u786e\u4e86\u53d8\u66f4\u7684\u8bc4\u4f30\u4e3b\u4f53\u662f\u4ea7\u54c1\u6301\u6709\u4eba\u6216\u8005\u662f\u53d8\u66f4\u7533\u8bf7\u4eba\uff0cFDA\u4ec5\u4ec5\u662f\u57fa\u4e8e\u7533\u8bf7\u4eba\u9012\u4ea4\u7684\u8d44\u6599\u6765\u5ba1\u8bc4\u7533\u8bf7\u4eba\u5bf9\u4e8e\u53d8\u66f4\u7684\u8bc4\u4f30\u662f\u5426\u5145\u5206\u3002\u5982\u679c\u6709\u7f3a\u9677\uff0c\u5305\u62ec\u53d8\u66f4\u5f52\u7c7b\u51fa\u9519\uff08\u901a\u5e38\u4e3a\u7533\u8bf7\u4eba\u5c06PAS\u7684\u7c7b\u578b\u5f52\u5165CBE-30\uff09\uff0cFDA\u4f1a\u63d0\u51fa\u76f8\u5e94\u8865\u5145\u8d44\u6599\u8981\u6c42\uff0c\u8981\u6c42\u4f01\u4e1a\u5b8c\u5584\u7814\u7a76\uff0c\u5e76\u4e14\u7ed9\u51fa\u5408\u7406\u7684\u5206\u7c7b\u4f9d\u636e\u548c\u8db3\u591f\u7684\u7814\u7a76\u8d44\u6599\u3002\u7531\u4e8e\u5728\u6574\u4e2a\u4ea7\u54c1\u7684\u751f\u547d\u5468\u671f\u4e2d\uff0c\u53d8\u66f4\u7684\u53d1\u751f\u662f\u7ecf\u5e38\u7684\uff0cFDA\u4f5c\u4e3a\u76d1\u7ba1\u673a\u6784\uff0c\u4e0d\u53ef\u80fd\u5c06\u6240\u6709\u53ef\u80fd\u7684\u53d8\u66f4\u60c5\u51b5\u901a\u8fc7\u4e00\u4e2a\u53d8\u66f4\u6280\u672f\u6307\u5bfc\u539f\u5219\u7f57\u5217\u6e05\u695a\uff0c\u56e0\u6b64\uff0c\u53ea\u6709\u8ba9\u4ea7\u54c1\u6301\u6709\u4eba\u6765\u505a\u76f8\u5e94\u7684\u53d8\u66f4\u8bc4\u4f30\uff0c\u9009\u62e9\u76f8\u5e94\u7684\u53d8\u66f4\u7533\u62a5\u9014\u5f84\u6765\u9012\u4ea4\u3002\u53ef\u4ee5\u8bf4\uff0cFDA\u7684\u53d8\u66f4\u6280\u672f\u6307\u5bfc\u539f\u5219\u662f\u57fa\u4e8e\u79d1\u5b66\u548c\u6280\u672f\u7684\u5ba2\u89c2\u6307\u5bfc\u539f\u5219\uff0c\u4e0d\u6d89\u53ca\u6cd5\u89c4\u6d41\u7a0b\u3002<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u4f46\u662f\uff0c\u5f53\u5305\u6750\u7684\u53d8\u66f4\u5f15\u8d77\u836f\u54c1\u7684\u53d8\u66f4\u65f6\uff0cFDA\u9047\u5230\u6700\u666e\u904d\u7684\u95ee\u9898\u5c31\u662f\u5305\u6750\u53d8\u66f4\u6267\u884c\u7684\u65f6\u95f4\u8282\u70b9\u95ee\u9898\u3002\u7531\u4e8e\u5bf9\u6574\u4e2a\u836f\u5305\u6750\u751f\u547d\u5468\u671f\u7684\u76d1\u7ba1\u662f\u4ee5\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u4e3a\u4e3b\uff0cFDA\u4ec5\u4ec5\u662f\u51fa\u5177\u76f8\u5e94\u7684\u6307\u5bfc\u539f\u5219\uff0c\u56e0\u6b64\u6d89\u53ca\u7684\u836f\u5305\u6750\u53d8\u66f4\u7ba1\u7406\uff0c\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u5728\u5176\u4e2d\u4e5f\u8d77\u7740\u4e3e\u8db3\u8f7b\u91cd\u7684\u4f5c\u7528\u3002\u836f\u5305\u6750\u7684\u6280\u672f\u8d44\u6599\u662f\u548c\u836f\u54c1\u7684\u7533\u62a5\u4e00\u8d77\u4f5c\u4e3aFDA\u5173\u8054\u5ba1\u8bc4\u7684\u5bf9\u8c61\uff0c\u56e0\u6b64\u5f53\u836f\u5305\u6750\u53d1\u751f\u53d8\u66f4\u540e\uff0c\u5176\u53d8\u66f4\u82e5\u89e6\u53d1\u836f\u54c1\u7684\u76f8\u5e94\u53d8\u66f4\uff0c\u5e76\u4e14\u9012\u4ea4\u8865\u5145\u7533\u8bf7\uff0c\u90a3\u4e48FDA\u4e5f\u5c06\u901a\u8fc7\u5bf9\u8865\u5145\u7533\u8bf7\u7684\u5173\u8054\u5ba1\u8bc4\uff0c\u540c\u65f6\u5ba1\u8bc4\u836f\u5305\u6750\u7684\u53d8\u66f4\u548c\u836f\u54c1\u7684\u53d8\u66f4\u3002\u5f53\u5ba1\u8bc4\u5b8c\u6210\u540e\uff0c\u836f\u5305\u6750\u548c\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u53cc\u65b9\u65b9\u53ef\u6267\u884c\u76f8\u5173\u7684\u53d8\u66f4\u3002\u5177\u4f53\u6d41\u7a0b\u89c1\u56fe&nbsp;1\u3002<\/p><table width=\"677\" style=\"width: 556px;\"><tbody style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><tr style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><td width=\"200\" align=\"center\" valign=\"middle\" style=\"padding: 0px;word-break: break-all;border-width: 0px;border-style: initial;border-color: initial;max-width: 100%;color: rgb(34, 34, 34);line-height: 20px;font-family: Arial, \u5b8b\u4f53;font-size: 12px;word-wrap: break-word !important;box-sizing: border-box !important;\"><img width=\"200\" title=\"\u836f\u5305\u6750\u53d8\u66f4\u7ba1\u7406\u7684\u5206\u6790\u4e0e\u63a2\u8ba8\" class=\"\"     style=\"border-width: 0px;border-style: initial;border-color: initial;vertical-align: middle;cursor: pointer;background-color: rgb(238, 237, 235);background-size: 22px;background-position: 50% 50%;background-repeat: no-repeat;box-sizing: border-box !important;word-wrap: break-word !important;width: 200px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/04\/7-1555470813.jpeg\" alt=\"\u836f\u5305\u6750\u53d8\u66f4\u7ba1\u7406\u7684\u5206\u6790\u4e0e\u63a2\u8ba8\"  \/><\/td><td align=\"left\" valign=\"middle\" style=\"padding: 0px;word-break: break-all;border-width: 0px;border-style: initial;border-color: initial;max-width: 100%;color: rgb(34, 34, 34);line-height: 20px;font-family: Arial, \u5b8b\u4f53;font-size: 12px;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"margin-left: 30px;max-width: 100%;word-wrap: break-word;display: block;text-indent: 0em;box-sizing: border-box !important;\"><span style=\"max-width: 100%;color: rgb(29, 150, 232);cursor: pointer;box-sizing: border-box !important;word-wrap: break-word !important;\">\u56fe 1<\/span>&nbsp;\u7f8e\u56fd\u836f\u5305\u6750\u53d8\u66f4\u5ba1\u8bc4\u6d41\u7a0b\u56fe<\/span><\/td><\/tr><\/tbody><\/table><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u5728\u56fe&nbsp;1\u663e\u793a\u7684\u53d8\u66f4\u6d41\u7a0b\u5b9e\u65bd\u8fc7\u7a0b\u4e2d\uff0c\u836f\u5305\u6750\u4f01\u4e1a\uff08DMF\u6301\u6709\u4eba\uff09\u7684\u53d8\u66f4\u5207\u6362\u53d6\u51b3\u4e8e\u836f\u54c1\u7684\u53d8\u66f4\u4f55\u65f6\u6279\u51c6\uff0c\u56e0\u6b64\uff0c\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u9700\u8981\u4e8b\u5148\u7ed9\u5305\u6750\u6301\u6709\u4eba\u4e00\u4e2a\u5927\u6982\u65f6\u95f4\uff0c\u4f7f\u5305\u6750\u4f01\u4e1a\u53ef\u4ee5\u5b8c\u6210\u76f8\u5e94\u65f6\u95f4\u6bb5\u7684\u5e93\u5b58\u548c\u5907\u8d27\uff0c\u5426\u5219\u5f88\u5bb9\u6613\u51fa\u73b0\u5305\u6750\u7684\u5e02\u573a\u65ad\u8d27\u6216\u8005\u5b58\u8d27\u8fc7\u591a\uff0c\u8fd9\u5bf9\u4e8e\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u548c\u5305\u6750\u4f01\u4e1a\u90fd\u662f\u4e00\u79cd\u635f\u5bb3\u3002\u5f53FDA\u7684\u5ba1\u8bc4\u65f6\u95f4\u4e0d\u786e\u5b9a\u65f6\uff0c\u5305\u6750\u4f01\u4e1a\u6267\u884c\u53d8\u66f4\u4e14\u83b7\u5f97\u65f6\u95f4\u4e5f\u65e0\u6cd5\u660e\u786e\uff0c\u4ece\u800c\u5bfc\u81f4\u5728\u5f00\u59cb\u6267\u884c\u65f6\uff0c\u6700\u666e\u904d\u7684\u73b0\u8c61\u5c31\u662f\u836f\u5305\u6750\u3001\u836f\u7528\u8f85\u6599\u3001\u539f\u6599\u836f\u7684\u4f9b\u5e94\u5546\u51fa\u73b0\u65ad\u8d27\u6216\u8005\u5e93\u5b58\u8fc7\u591a\uff0c\u4ea7\u80fd\u6d6a\u8d39\u3002\u5728\u6574\u4e2a\u8fc7\u7a0b\u4e2d\uff0c\u4e0d\u786e\u5b9a\u56e0\u7d20\u5728\u4e8eFDA\u7684\u5ba1\u8bc4\u9636\u6bb5\uff0c\u82e5\u4f5c\u4e3a\u76d1\u7ba1\u65b9\u7684FDA\u660e\u786e\u4e86\u5bf9\u4e8e\u836f\u54c1\u7684\u4e09\u7c7b\u8865\u5145\u7533\u8bf7\u7684\u65f6\u9650\uff0c\u4e5f\u5c31\u89c4\u907f\u4e86\u8fd9\u4e2a\u95ee\u9898\u3002<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u9664\u4e86\u4e0a\u8ff0\u65f6\u95f4\u95ee\u9898\uff0c\u5bf9\u4e8eFDA\u7684\u76d1\u7ba1\u4e5f\u63d0\u51fa\u65b0\u7684\u8981\u6c42\u3002\u867d\u7136\u6b64\u7c7b\u53d8\u66f4\u7ba1\u7406\u6a21\u5f0f\u662f\u4ee5\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u4e3a\u4e3b\uff0c\u4f46\u662f\u7531\u4e8e\u836f\u4f01\u5bf9\u5305\u6750\u4f01\u4e1a\u7684\u76d1\u7ba1\u8fd8\u662f\u7247\u9762\u7684\uff0c\u65e0\u6cd5\u4ece\u6574\u4e2a\u884c\u4e1a\u7684\u5927\u8303\u56f4\u548c\u5927\u73af\u5883\u5165\u624b\u53bb\u5224\u65ad\u548c\u63d0\u524d\u9884\u9632\uff0c\u8fd9\u4e2a\u65f6\u5019\u5bf9FDA\u7684\u8f85\u52a9\u76d1\u7ba1\u80fd\u529b\u5c31\u63d0\u51fa\u4e86\u8981\u6c42\uff0c\u5373\u8f83\u9ad8\u6c34\u5e73\u7684\u76d1\u7ba1\u80fd\u529b\u548c\u6bd4\u8f83\u5b8c\u5584\u7684\u76d1\u7ba1\u4f53\u7cfb\uff0c\u5305\u62ec\u73b0\u573a\u6838\u67e5\u3001\u5e74\u62a5\u5ba1\u67e5\u3001\u5e02\u573a\u62bd\u67e5\u3001\u4e0d\u826f\u4e8b\u4ef6\u53d1\u751f\u524d\u7684\u9884\u5224\u548c\u63a7\u5236\uff0c\u4ee5\u53ca\u53d1\u751f\u540e\u7684\u6551\u6cbb\u548c\u60e9\u6cbb\uff0c\u4ece\u800c\u5c06\u5371\u5bb3\u964d\u5230\u6700\u4f4e\u3002\u53ea\u6709\u76d1\u7ba1\u673a\u6784\u548c\u6574\u4e2a\u884c\u4e1a\u76f8\u4e92\u4fe1\u4efb\uff0c\u7d27\u5bc6\u5408\u4f5c\uff0c\u624d\u80fd\u4fdd\u8bc1\u4ea7\u54c1\u5728\u751f\u547d\u5468\u671f\u5185\u53ef\u4ee5\u5f88\u597d\u5730\u4fdd\u8bc1\u60a3\u8005\u5f97\u5230\u8db3\u591f\u7684\u6536\u76ca\u3002<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u7efc\u4e0a\u6240\u8ff0\uff0c\u5bf9\u4e8e\u836f\u5305\u6750\u53d8\u66f4\u7ba1\u7406\u4e2d\u201c\u836f\u4f01\u4e3a\u4e3b\uff0c\u836f\u76d1\u8f85\u52a9\u201d\u7684\u524d\u63d0\u6761\u4ef6\u6709\u4e24\u70b9\uff1a\u4e00\u662f\u884c\u4e1a\u5185\u4f01\u4e1a\u7684\u5e73\u5747\u6c34\u5e73\u6bd4\u8f83\u9ad8\uff0c\u4f01\u4e1a\u6709\u80fd\u529b\u5bf9\u53d8\u66f4\u505a\u5230\u5c3d\u91cf\u5ba2\u89c2\u548c\u79d1\u5b66\u7684\u8bc4\u4f30\uff0c\u7136\u540e\u505a\u51fa\u76f8\u5e94\u7684\u9a8c\u8bc1\u548c\u7814\u7a76\u5de5\u4f5c\uff1b\u4e8c\u662f\u76d1\u7ba1\u673a\u6784\u5177\u6709\u8f83\u9ad8\u6c34\u5e73\u7684\u76d1\u7ba1\u80fd\u529b\u548c\u6bd4\u8f83\u5b8c\u5584\u7684\u76d1\u7ba1\u4f53\u7cfb\uff0c\u4ee5\u53ca\u516c\u5f00\u900f\u660e\u7684\u76d1\u7ba1\u5ba1\u6279\u6d41\u7a0b\u3002<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span level=\"1\" style=\"padding-top: 3px;padding-bottom: 3px;max-width: 100%;display: block;font-weight: bold;font-size: 18px;line-height: 25px;text-indent: 0em;background-color: rgb(225, 225, 225);box-sizing: border-box !important;word-wrap: break-word !important;\">3 \u5bf9\u6211\u56fd\u836f\u5305\u6750\u6cd5\u89c4\u6539\u9769\u7684\u542f\u793a<\/span><\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">FDA\u7684DMF\u5236\u5ea6\u53ca\u5176\u5bf9\u5305\u6750\u53d8\u66f4\u7684\u76d1\u7ba1\u4ee5\u53ca\u5bf9\u4e8e\u836f\u5305\u6750\u6807\u51c6\u7684\u8981\u6c42\u5df2\u7ecf\u975e\u5e38\u6210\u719f\uff0c\u5bf9\u4e8e\u6211\u56fd\u63a2\u7d22\u5e76\u4e14\u5efa\u7acb\u836f\u5305\u6750\u4e0a\u5e02\u540e\u53d8\u66f4\u76d1\u7ba1\u7684\u5236\u5ea6\u6709\u975e\u5e38\u5927\u7684\u501f\u9274\u610f\u4e49\u3002<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u8fd1\u4e09\u5e74\u6765\uff0c\u968f\u7740\u6211\u56fd\u836f\u54c1\u6539\u9769\uff0c\u836f\u5305\u6750\u7684\u76f8\u5e94\u6cd5\u89c4\u4e5f\u5728\u53d1\u751f\u7740\u5de8\u5927\u53d8\u5316\uff0c\u6700\u4e3b\u8981\u7684\u5c31\u662f\u6211\u56fd\u539f\u6599\u836f\u3001\u836f\u7528\u8f85\u6599\u548c\u836f\u5305\u6750\u7684\u5171\u540c\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u3002\u4ece\u65b0\u7684\u5236\u5ea6\u4e0a\u770b\uff0c\u9664\u4e86\u7533\u62a5\u8d44\u6599\u7684\u6280\u672f\u8981\u6c42\uff0c\u6574\u4e2a\u6cd5\u89c4\u6d41\u7a0b\u6b63\u5728\u4e0eFDA\u7684DMF\u5907\u6848\u4ee5\u53ca\u5173\u8054\u5ba1\u8bc4\u5236\u5ea6\u63a5\u8f68\u3002\u56fd\u5bb6\u836f\u54c1\u76d1\u7ba1\u90e8\u95e8\u5f00\u59cb\u6162\u6162\u653e\u6743\u7ed9\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\uff0c\u5bf9\u4e8e\u539f\u6599\u836f\u3001\u836f\u7528\u8f85\u6599\u548c\u836f\u5305\u6750\u7684\u8d28\u91cf\uff0c\u4ee5\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u76d1\u7ba1\u4e3a\u4e3b\uff0c\u836f\u76d1\u673a\u6784\u4e3b\u8981\u76d1\u7ba1\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u3002\u8fd9\u6837\u51cf\u5c11\u4e86\u653f\u5e9c\u673a\u6784\u53c2\u4e0e\u5e02\u573a\u8fd0\u4f5c\u7684\u7a0b\u5ea6\uff0c\u4f7f\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u4ece\u81ea\u8eab\u5229\u76ca\u51fa\u53d1\uff0c\u66f4\u52a0\u8c28\u614e\u5730\u9009\u62e9\u7814\u53d1\u5f3a\u3001\u751f\u4ea7\u7a33\u3001\u8d28\u91cf\u597d\u7684\u836f\u5305\u6750\u751f\u4ea7\u4f01\u4e1a\u4f5c\u4e3a\u4f9b\u5e94\u5546\u3002<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u4ece\u836f\u76d1\u89d2\u5ea6\u51fa\u53d1\uff0c\u66f4\u5e94\u8be5\u6e05\u9192\u5730\u8ba4\u8bc6\u5230\uff0c\u6211\u56fd\u76ee\u524d\u836f\u5305\u6750\u4f01\u4e1a\u5c0f\u800c\u6563\u4e71\uff0c\u8d28\u91cf\u610f\u8bc6\u4e0d\u8db3\uff0c\u5404\u5730\u5305\u6750\u4f01\u4e1a\u80fd\u529b\u4e0d\u4e00\uff0c\u800c\u5404\u5730\u76d1\u7ba1\u4e5f\u5b58\u5728\u5c3a\u5ea6\u7684\u504f\u5dee\u3002\u56e0\u6b64\uff0c\u56fd\u5bb6\u836f\u54c1\u76d1\u7ba1\u90e8\u95e8\u9700\u8981\u63a8\u51fa\u4e0e\u5171\u540c\u5ba1\u8bc4\u5236\u5ea6\u76f8\u5173\u7684\u914d\u5957\u6cd5\u89c4\u3001\u6807\u51c6\u4e0e\u6280\u672f\u6307\u5bfc\u6587\u4ef6\uff0c\u6bd4\u5982\u5728\u300a\u836f\u54c1\u7ba1\u7406\u6cd5\u300b\u4ee5\u53ca\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\u7684\u4fee\u8ba2\u4e2d\u8003\u8651\u5230\u836f\u5305\u6750\u53d8\u66f4\u5bf9\u836f\u54c1\u7684\u5f71\u54cd\uff0c\u5c3d\u5feb\u66f4\u65b0\u5b8c\u558410\u5e74\u524d\u53d1\u5e03\u7684\u300a\u836f\u54c1\u4e0a\u5e02\u540e\u53d8\u66f4\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\uff0c\u51fa\u53f0\u836f\u5305\u6750\u53d8\u66f4\u5206\u7c7b\u4ee5\u53ca\u5e94\u5f00\u5c55\u7684\u76f8\u5173\u6280\u672f\u7814\u7a76\u6307\u5357\u7b49\u7b49\uff0c\u5b9e\u73b0\u653f\u5e9c\u76d1\u7ba1\u3001\u884c\u4e1a\u81ea\u5f8b\u3001\u4f01\u4e1a\u81ea\u89c9\u7684\u591a\u7ef4\u5ea6\u836f\u54c1\u8d28\u91cf\u4fdd\u8bc1\u4f53\u7cfb\u3002<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u5bf9\u4e8e\u836f\u5305\u6750\u53d8\u66f4\uff0c\u56fd\u5185\u76f8\u5173\u7f51\u7ad9\u53d1\u5e03\u4e86\u300a\u836f\u5305\u6750\u53d8\u66f4\u7814\u7a76\u6307\u5357\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b<sup style=\"max-width: 100%;word-wrap: break-word;line-height: 0px;word-break: break-all;box-sizing: border-box !important;\">[<span style=\"max-width: 100%;word-wrap: break-word;line-height: 0px;word-break: break-all;box-sizing: border-box !important;\">8<\/span>]<\/sup>\uff0c\u5c06\u53d8\u66f4\u5206\u4e3a\u6280\u672f\u7c7b\u53d8\u66f4\u548c\u975e\u6280\u672f\u7c7b\u53d8\u66f4\uff0c\u4f7f\u7528\u8303\u56f4\u9650\u5b9a\u5728\u836f\u5305\u6750\u751f\u4ea7\u4f01\u4e1a\u53d1\u751f\u7684\u5404\u7c7b\u53d8\u66f4\u4ee5\u53ca\u5e94\u5f00\u5c55\u7684\u7814\u7a76\u548c\u8bc4\u4f30\uff0c\u7efc\u5408\u8bc4\u4f30\u539f\u5219\u8003\u8651\u57fa\u4e8e\u98ce\u9669\u548c\u7b49\u540c\u6027\u3002\u8be5\u6307\u5357\u5bf9\u884c\u4e1a\u5177\u6709\u5f88\u597d\u7684\u6307\u5bfc\u610f\u4e49\uff0c\u5efa\u8bae\u300a\u836f\u5305\u6750\u53d8\u66f4\u7814\u7a76\u6307\u5357\u300b\u5148\u671f\u5728\u884c\u4e1a\u5185\u4f5c\u4e3a\u63a8\u8350\u6027\u89c4\u8303\uff0c\u4e3a\u836f\u5305\u6750\u751f\u4ea7\u4f01\u4e1a\u4e0e\u5236\u836f\u4f01\u4e1a\u7b7e\u7f72\u8d28\u91cf\u534f\u8bae\u4f5c\u53c2\u8003\uff0c\u540c\u65f6\u4e5f\u4e3a\u5236\u836f\u4f01\u4e1a\u5bf9\u836f\u5305\u6750\u4f01\u4e1a\u8fdb\u884c\u4f9b\u5e94\u5546\u5ba1\u8ba1\u63d0\u4f9b\u3002<\/p><p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;widows: 1;border-width: 0px;border-style: initial;border-color: initial;color: rgb(34, 34, 34);line-height: 22px;text-indent: 2em;font-family: Arial, \u5b8b\u4f53;font-size: 12px;overflow-wrap: break-word;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u5173\u8054\u5ba1\u8bc4\u5ba1\u6279\u4e0d\u662f\u4e00\u52b3\u6c38\u9038\u7684\u5b8c\u7f8e\u5236\u5ea6\uff0c\u5728\u5b9e\u65bd\u8fc7\u7a0b\u4e2d\uff0c\u7279\u522b\u662f\u4e0a\u5e02\u540e\u7684\u76d1\u7ba1\u8fc7\u7a0b\u4e2d\u8fd8\u4f1a\u51fa\u73b0\u8fd9\u6837\u90a3\u6837\u7684\u76d1\u7ba1\u76f2\u70b9\u3002\u8fd9\u5c31\u9700\u8981\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u90e8\u95e8\u5bf9\u836f\u54c1\u4e0a\u5e02\u540e\u518d\u8bc4\u4ef7\u8fdb\u884c\u89c4\u8303\u548c\u5ef6\u4f38\u7ba1\u7406\uff0c\u5b9e\u73b0\u836f\u54c1\u6574\u4e2a\u751f\u547d\u5468\u671f\u7684\u76d1\u7763\u548c\u7ba1\u7406\uff0c\u4e5f\u662f\u5bf9\u836f\u5305\u6750\u5728\u751f\u4ea7\u548c\u4f7f\u7528\u8fc7\u7a0b\u4e2d\u53d1\u751f\u53d8\u66f4\u4ece\u800c\u5bfc\u81f4\u5bf9\u836f\u54c1\u8d28\u91cf\u5f71\u54cd\u7684\u5ba2\u89c2\u8bc4\u4ef7\u3002\u6211\u56fd\u5b9e\u65bd\u539f\u8f85\u6599\u5305\u6750\u4e0e\u836f\u54c1\u5171\u540c\u5ba1\u8bc4\u5ba1\u6279\u540e\uff0c\u4e0d\u4ec5\u4ec5\u662f\u836f\u5305\u6750\uff0c\u539f\u6599\u836f\u548c\u836f\u7528\u8f85\u6599\u4e5f\u9700\u8981\u8ddf\u7740\u836f\u54c1\u7684\u53d8\u66f4\u5b9e\u65bd\u540c\u65f6\u8fdb\u884c\uff0c\u5b9e\u73b0\u6574\u4e2a\u884c\u4e1a\u5171\u540c\u8fdb\u6b65\u3002<\/p><\/section><\/section><\/section><\/pre>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p><br  \/><\/p>\n<section style=\"margin-top: -1em;padding: 20px 10px 10px;max-width: 100%;box-sizing: border-box;font-size: 16px;line-height: 25.6px;font-family: monospace;letter-spacing: 0.544px;text-align: center;border-width: 1px;border-style: solid;border-color: rgb(204, 204, 204);box-shadow: rgb(165, 165, 165) 4px 4px 2px;background-color: rgb(254, 255, 255);word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;text-align: left;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;line-height: 25.6px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;text-align: center;line-height: 25.6px;font-family: \u5fae\u8f6f\u96c5\u9ed1;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;font-size: 16px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;line-height: 25.6px;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;font-size: 16px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;line-height: 25.6px;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;font-size: 16px;letter-spacing: 0.5px;line-height: 25.6px;text-align: justify;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;line-height: 25.6px;font-size: 12px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;line-height: 22.72px;font-family: \u5b8b\u4f53;white-space: pre-wrap;box-sizing: border-box !important;word-wrap: break-word !important;\">\u514d\u8d23\u58f0\u660e\uff1a\u6587\u7ae0<\/span><span style=\"max-width: 100%;line-height: 22.72px;font-family: \u5b8b\u4f53;white-space: pre-wrap;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7248\u6743\u5f52\u539f\u4f5c\u8005\u6240\u6709\u3002\u5982\u6d89\u53ca\u4f5c\u54c1\u5185\u5bb9\u3001\u7248\u6743\u548c\u5176\u5b83\u95ee\u9898\uff0c\u8bf7\u8ddf\u6211\u4eec\u8054\u7cfb\u5220\u9664\uff01\u6587\u7ae0\u5185\u5bb9\u4e3a\u4f5c\u8005\u4e2a\u4eba\u89c2\u70b9,\u5e76\u4e0d\u4ee3\u8868\u672c\u516c\u4f17\u53f7\u8d5e\u540c\u6216\u652f\u6301\u5176\u89c2\u70b9\u3002\u672c\u516c\u4f17\u53f7\u62e5\u6709\u5bf9\u6b64\u58f0\u660e\u7684\u6700\u7ec8\u89e3\u91ca\u6743\u3002<\/span><\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p style=\"max-width: 100%;min-height: 1em;font-size: 16px;line-height: 25.6px;color: rgb(62, 62, 62);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;text-align: center;line-height: 25.6px;font-family: \u5fae\u8f6f\u96c5\u9ed1;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/strong><\/span><span style=\"max-width: 100%;line-height: 25.6px;color: rgb(255, 0, 0);box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;text-align: center;line-height: 25.6px;font-family: \u5fae\u8f6f\u96c5\u9ed1;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;\u626b\u63cf\u5173\u6ce8\u4e8c\u7ef4\u7801\uff0c<strong style=\"max-width: 100%;font-size: 16px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;line-height: 25.6px;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6bcf\u5929\u90fd\u6709\u836f\u5c4a\u65b0\u95fb\u548c<\/span><\/strong><\/span><\/strong><strong style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;text-align: center;line-height: 25.6px;font-family: \u5fae\u8f6f\u96c5\u9ed1;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;font-size: 16px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;line-height: 25.6px;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8bfe\u4ef6\u4e0e\u5927\u5bb6\u4e00\u8d77\u5206\u4eab\u3002<\/span><\/strong><\/span><\/strong><\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;line-height: 27.2px;box-sizing: border-box !important;word-wrap: break-word !important;\"><br  \/><\/p>\n<section class=\"\" style=\"margin-top: -15px;margin-left: auto;max-width: 100%;box-sizing: border-box;font-size: 16px;line-height: 25.6px;color: rgb(62, 62, 62);width: 15px;height: 15px;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/section>\n<section class=\"\" style=\"margin-top: -15px;margin-left: auto;max-width: 100%;box-sizing: border-box;font-size: 16px;line-height: 25.6px;color: rgb(62, 62, 62);width: 15px;height: 15px;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/section>\n<section class=\"\" style=\"margin-top: -15px;margin-left: auto;max-width: 100%;box-sizing: border-box;font-size: 16px;line-height: 25.6px;color: rgb(62, 62, 62);width: 15px;height: 15px;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/section>\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;letter-spacing: 0.544px;font-size: 16px;line-height: 25.6px;color: rgb(62, 62, 62);word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"padding: 10px;max-width: 100%;box-sizing: border-box;border-width: 0.8em;border-style: solid;border-color: initial;-webkit-border-image: url(&quot;https:\/\/mmbiz.qpic.cn\/mmbiz_png\/eDotHGpLa9iaVykicX5tjlhGZ5jW3oibriaF82BicV2NNj6Plb10qgnQxMbla2HOAjibV5lOeNW4RqjYShjEuZnAg3bQ\/640?wx_fmt=png&quot;) 54 fill;word-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;text-align: center;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;min-height: 1em;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(172, 57, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;background-color: rgb(255, 251, 0);box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;letter-spacing: 0.544px;line-height: 25.6px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;background-color: rgb(255, 251, 0);box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box;color: rgb(62, 62, 62);line-height: 25.6px;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box;color: rgb(152, 12, 196);word-wrap: break-word !important;\">\u57f9\u8bad\u901a\u77e5\uff1a&nbsp;<\/span><\/strong><\/span><\/strong><\/strong><\/span><\/strong><\/span><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<table cellpadding=\"0\" cellspacing=\"0\" width=\"631\" style=\"width: 556px;\">\n<tbody style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<tr height=\"53\" style=\"max-width: 100%;height: 53px;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<td height=\"53\" width=\"48\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\">\u5730\u70b9<\/td>\n<td width=\"106\" u1:str=\"\" style=\"word-break: break-all;border-left-style: none;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\">&nbsp;\u65f6\u95f4<\/td>\n<td width=\"300\" u1:str=\"\" style=\"word-break: break-all;border-left-style: none;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\">&nbsp; &nbsp;&nbsp; &nbsp;<span style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u70b9\u5f00\u94fe\u63a5\u9884\u89c8\u5168\u6587<\/span><\/td>\n<\/tr>\n<tr style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;letter-spacing: 0.544px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u676d\u5dde<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;font-size: 14px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\">4\u670815-17\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><strong style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Helvetica, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247493528&amp;idx=7&amp;sn=1804e488d97b6be144a8bf3008fdbca7&amp;scene=21#wechat_redirect\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3010\u5357\u4eac\u3011\u201c\u836f\u5382\u7b26\u5408<\/span><span style=\"max-width: 100%;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">GMP<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u7ef4\u62a4\u548c\u7ef4\u4fee\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;letter-spacing: 0.544px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5357\u4eac<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;font-size: 14px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\">4\u670817-19\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><strong style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Helvetica, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247493496&amp;idx=7&amp;sn=027fc009d5d7a0858a81b8acb3c3ccd9&amp;scene=21#wechat_redirect\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3010\u5357\u4eac\u3011\u201c\u836f\u4f01\u5982\u4f55\u5f00\u5c55\u4e34\u5e8a\u524d\u5b89\u5168\u6027\u7814\u7a76\u4e13\u9898\u57f9\u8bad\u73ed\uff08<\/span><span style=\"max-width: 100%;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">ICH S<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6307\u5bfc\uff09\u201d\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u957f\u6c99<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">4\u670818-20\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Helvetica, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247493644&amp;idx=6&amp;sn=28486658c9ac9763a714c07390854711&amp;scene=21#wechat_redirect\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3010\u957f\u6c99\u3011\u201c\u57fa\u4e8e<\/span><span style=\"max-width: 100%;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">WHO<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6307\u5357\u3001<\/span><span style=\"max-width: 100%;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">ISO14644<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u5236\u836f\u5382\u6d01\u51c0\u516c\u7528\u7cfb\u7edf\u9a8c\u8bc1<\/span><span style=\"max-width: 100%;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\/<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u786e\u8ba4\u9ad8\u7ea7\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6b66\u6c49<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">4\u670819-21\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Helvetica, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247494003&amp;idx=6&amp;sn=2433299b53c5101a1b7d88dc03349a12&amp;scene=21#wechat_redirect\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3010\u6b66\u6c49\u3011\u7b2c\u4e09\u671f\u201c<\/span><span style=\"max-width: 100%;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">2019 ICH-CTD<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7533\u62a5\u8d44\u6599\u64b0\u5199\u53ca\u51c6\u5907\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6210\u90fd<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">4\u670825-27\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\">\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Helvetica, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247493671&amp;idx=6&amp;sn=ea35218321f0ad60a07122902058cd5a&amp;scene=21#wechat_redirect\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3010\u674e\u6c38\u5eb7\u3011\u7b2c\u4e8c\u3001\u4e09\u671f\u201c<\/span><span style=\"max-width: 100%;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">2019<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u836f\u54c1\u6280\u672f\u8f6c\u79fb\u3001\u5de5\u827a\u9a8c\u8bc1\u548c\u6e05\u6d01\u9a8c\u8bc1\u5b9e\u7528\u6280\u672f\u9ad8\u7ea7\u7ecf\u7406\u63d0\u5347\u73ed\u201d\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n<tr style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;letter-spacing: 0.544px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5357\u4eac<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;font-size: 14px;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\">4\u670826-28\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><strong style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Helvetica, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247493661&amp;idx=7&amp;sn=1b69c1a5a8bf6691af950c50a173c407&amp;scene=21#wechat_redirect\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3010\u5357\u4eac\u3011\u201c<\/span><span style=\"max-width: 100%;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">2019<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u836f\u54c1\u4f9b\u5e94\u94fe\u53ca\u4fe1\u606f\u5316\u8ffd\u6eaf\u65b0\u6cd5\u89c4\u5b9e\u65bd\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5<\/span><\/a><\/strong><\/span><\/strong><\/td>\n<\/tr>\n<tr style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6b66\u6c49<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">4\u670826-28\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Helvetica, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247493613&amp;idx=6&amp;sn=8f3398c74e20d038389d37f77ce00055&amp;scene=21#wechat_redirect\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3010\u6b66\u6c49\u3011\u7b2c\u4e09\u671f\u201c\u751f\u7269\u53d1\u4e0e\u6ce8\u518c\u7533\u62a5\u53ca\u8d28\u91cf\u7814\u7a76\u201d<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e13\u9898\u7814\u4fee\u73ed\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;letter-spacing: 0.544px;widows: 1;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5317\u4eac<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">4\u670826-28\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Helvetica, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247494020&amp;idx=6&amp;sn=ab31171241300ffe1686a901cf10e406&amp;scene=21#wechat_redirect\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5173\u4e8e\u4e3e\u529e\u73b0\u884c\u6cd5\u89c4\u540e\u671f<\/span><span style=\"max-width: 100%;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">&#8212;<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u201c\u4fdd\u5065\u98df\u54c1\u6807\u7b7e\u89c4\u8303\u7ba1\u7406\u3001\u5ef6\u7eed\u6ce8\u518c\u8981\u6c42\u3001\u5de5\u827a\u7814\u7a76\u548c\u9a8c\u8bc1\u4e0e\u5e02\u573a\u5408\u89c4\u9500\u552e\u201d\u4e13\u5bb6\u4e92\u52a8\u7b54\u7591\u4f1a<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;letter-spacing: 0.544px;widows: 1;box-sizing: border-box !important;word-wrap: break-word !important;\">\u676d\u5dde<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">5\u67089-11\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Helvetica, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247494209&amp;idx=8&amp;sn=ee839137b557fdc08aa34ee58f1005b7&amp;scene=21#wechat_redirect\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3010\u676d\u5dde\u3011<\/span><span style=\"max-width: 100%;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">2019<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7b2c\u4e09\u5c4a\u5fae\u5316\u5de5\u6280\u672f\u7814\u7a76\u4e0e\u884c\u4e1a\u5e94\u7528\u53ca\u5de5\u827a\u4f18\u5316\u5de5\u7a0b\u8bbe\u8ba1\u7814\u8ba8\u4f1a\u201d\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6d4e\u5357<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">5\u670810-12\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Helvetica, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247493613&amp;idx=6&amp;sn=8f3398c74e20d038389d37f77ce00055&amp;scene=21#wechat_redirect\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3010\u6d4e\u5357\u3011\u7b2c\u56db\u671f\u201c\u751f\u7269\u53d1\u4e0e\u6ce8\u518c\u7533\u62a5\u53ca\u8d28\u91cf\u7814\u7a76\u201d<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e13\u9898\u7814\u4fee\u73ed\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5357\u4eac<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">5\u670817-19\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Helvetica, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247494209&amp;idx=7&amp;sn=3a4d8f92091bbc9f0969e5f6ccf178de&amp;scene=21#wechat_redirect\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">2019<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5236\u836f\u884c\u4e1a\u4fe1\u606f\u5316\u5347\u7ea7\u9ad8\u5c42\u8bba\u575b\u3010\u5357\u4eac\u3011<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e0a\u6d77<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">5\u670818-20\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Helvetica, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247494279&amp;idx=5&amp;sn=eb663b3b73a24d7e51fb0c7e73da5adf&amp;scene=21#wechat_redirect\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3010\u4e0a\u6d77\u3011\u201c<\/span><span style=\"max-width: 100%;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">2019&nbsp;<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u65b0\u5efa<\/span><span style=\"max-width: 100%;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">GMP<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5de5\u5382\u5de5\u7a0b\u7ba1\u7406\u5b9e\u64cd\u4e13\u9898\u57f9\u8bad\u73ed\u201d<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u592a\u539f<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;font-size: 14px;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\">5\u670818-20\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\">\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Helvetica, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247494309&amp;idx=7&amp;sn=e2de53e29d1171105803a084dcc825d0&amp;scene=21#wechat_redirect\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u201c\u4e2d\u533b\u836f\u52a9\u529b\u5065\u5eb7\u4ea7\u4e1a\u2014\u2014<\/span><span style=\"max-width: 100%;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">2019<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u836f\u98df\u4e24\u7528\u5065\u5eb7\u98df\u54c1\u4ea7\u54c1\u5f00\u53d1\u4e0e\u751f\u4ea7\u5e94\u7528\u5173\u952e\u6280\u672f\u521b\u65b0\u4ea4\u6d41\u4f1a\u201d\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n<tr style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6d4e\u5357<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;font-size: 14px;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\">5\u670819-21\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><strong style=\"max-width: 100%;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Helvetica, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247494324&amp;idx=6&amp;sn=191f5f8793086fe36609a731e608f7f4&amp;scene=21#wechat_redirect\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3010\u674e\u6c38\u5eb7\u3011\u201c<\/span><span style=\"max-width: 100%;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">2019<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u836f\u54c1\u6280\u672f\u8f6c\u79fb\u3001\u5de5\u827a\u9a8c\u8bc1\u548c\u6e05\u6d01\u9a8c\u8bc1\u5b9e\u7528\u6280\u672f\u9ad8\u7ea7\u7ecf\u7406\u63d0\u5347\u73ed\u201d\u6d4e\u5357\u7ad9<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u676d\u5dde<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">5\u670823-25\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Helvetica, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247494209&amp;idx=6&amp;sn=1c3e2ad5079f336c624b064b24ea638e&amp;scene=21#wechat_redirect\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3010\u676d\u5dde\u3011\u201c<\/span><span style=\"max-width: 100%;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">2020<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7248\u836f\u5178\u76f8\u5173\u89e3\u6790\u4e0e\u8d28\u91cf\u5206\u6790\u7814\u7a76\u5b9e\u8df5\u201d<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7814\u4fee\u73ed\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5357\u4eac<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">5\u670824-26\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Helvetica, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247494279&amp;idx=6&amp;sn=0fe2a65ca01b2a4d3cfee6b34074ed91&amp;scene=21#wechat_redirect\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3010\u5357\u4eac\u3011\u201c\u7b2c\u4e94\u671f\u6676\u578b\u836f\u7269\u54c1\u79cd\u7814\u7a76\u53ca\u7ed3\u6676\u8fc7\u7a0b\u7814\u7a76\u5f00\u53d1\u8bbe\u8ba1\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u91cd\u5e86<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;font-size: 14px;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\">6\u670811-13\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><strong style=\"max-width: 100%;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Helvetica, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247494324&amp;idx=6&amp;sn=191f5f8793086fe36609a731e608f7f4&amp;scene=21#wechat_redirect\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3010\u674e\u6c38\u5eb7\u3011\u201c<\/span><span style=\"max-width: 100%;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">2019<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u836f\u54c1\u6280\u672f\u8f6c\u79fb\u3001\u5de5\u827a\u9a8c\u8bc1\u548c\u6e05\u6d01\u9a8c\u8bc1\u5b9e\u7528\u6280\u672f\u9ad8\u7ea7\u7ecf\u7406\u63d0\u5347\u73ed\u201d\u91cd\u5e86<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<tr style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e7f\u5dde<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><span style=\"max-width: 100%;font-size: 14px;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\">6\u670814-16\u65e5<\/span><\/td>\n<td u1:str=\"\" colspan=\"1\" rowspan=\"1\" style=\"word-break: break-all;max-width: 100%;word-wrap: break-word !important;box-sizing: border-box !important;\"><strong style=\"max-width: 100%;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Helvetica, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5NTUxNTg4Mw==&amp;mid=2247494324&amp;idx=6&amp;sn=191f5f8793086fe36609a731e608f7f4&amp;scene=21#wechat_redirect\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3010\u674e\u6c38\u5eb7\u3011\u201c<\/span><span style=\"max-width: 100%;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">2019<\/span><span style=\"max-width: 100%;font-family: \u7b49\u7ebf;font-weight: normal;box-sizing: border-box !important;word-wrap: break-word !important;\">\u836f\u54c1\u6280\u672f\u8f6c\u79fb\u3001\u5de5\u827a\u9a8c\u8bc1\u548c\u6e05\u6d01\u9a8c\u8bc1\u5b9e\u7528\u6280\u672f\u9ad8\u7ea7\u7ecf\u7406\u63d0\u5347\u73ed\u201d\u5e7f\u5dde<\/span><\/a><\/span><\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"max-width: 100%;line-height: 25.6px;letter-spacing: 0.544px;color: rgb(255, 41, 65);box-sizing: border-box !important;word-wrap: break-word !important;\">\u7ec4\u56e2\u62a5\u540d\u53ef\u4eab\u53d7\u4f18\u60e0&nbsp;\u6b22\u8fce\u54a8\u8be2\u62a5\u540d\uff1a<\/span><span style=\"max-width: 100%;line-height: 25.6px;letter-spacing: 0.544px;color: rgb(172, 57, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u674e\u5a1f13641150050 \u5fae\u4fe1\u540c\u53f7<\/span><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p><br  \/><\/p>\n<p><br  \/><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u70b9\u51fb\u5173\u6ce8\u2191\u6280\u672f\u6c47 \u6b22\u8fce\u70b9\u8d5e\u548c\u8f6c\u53d1\u54e6~\u70b9\u51fb\u67e5\u9605&nbsp;2019\u5236\u836f\u57f9\u8bad\u901a\u77e55\u670818-20\u65e5\u3010\u4e0a\u6d77\u3011\u201c2019 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":84473,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/84472"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=84472"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/84472\/revisions"}],"predecessor-version":[{"id":84480,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/84472\/revisions\/84480"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/84473"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=84472"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=84472"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=84472"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}