{"id":349,"date":"2018-06-27T01:00:00","date_gmt":"2018-07-27T06:19:15","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/27\/%e5%b9%b2%e8%b4%a7-%e6%97%a5%e6%9c%ac%e5%88%9b%e6%96%b0%e8%8d%af%e7%89%a9%e5%ae%a1%e6%89%b9%e7%ae%a1%e7%90%86%e6%94%bf%e7%ad%96%e5%8f%8a%e5%85%b6%e5%ae%9e%e6%96%bd%e6%95%88%e6%9e%9c%e7%a0%94\/"},"modified":"2018-07-27T14:19:16","modified_gmt":"2018-07-27T06:19:16","slug":"%e5%b9%b2%e8%b4%a7-%e6%97%a5%e6%9c%ac%e5%88%9b%e6%96%b0%e8%8d%af%e7%89%a9%e5%ae%a1%e6%89%b9%e7%ae%a1%e7%90%86%e6%94%bf%e7%ad%96%e5%8f%8a%e5%85%b6%e5%ae%9e%e6%96%bd%e6%95%88%e6%9e%9c%e7%a0%94","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/349\/","title":{"rendered":"\u5e72\u8d27 | \u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u53ca\u5176\u5b9e\u65bd\u6548\u679c\u7814\u7a76"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<p style=\"text-align: center;\"><span style=\"font-size: 20px;\"><strong>\u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u53ca\u5176\u5b9e\u65bd\u6548\u679c\u7814\u7a76<\/strong><\/span><\/p>\n<p style=\"text-align: center;\"><strong>Performance of Approval Regulation Policies on&nbsp;<\/strong><strong>Innovative Drug in Japan and Its Enlightenment<\/strong><\/p>\n<p style=\"text-align: center;\">\u9648\u6c38\u6cd5\uff0c\u738b\u6bd3\u4e30\uff0c\u4f0d \u7433<\/p>\n<p style=\"text-align: center;\">(\u4e2d\u56fd\u836f\u79d1\u5927\u5b66\uff0c\u6c5f\u82cf\u5357\u4eac 211198)<\/p>\n<p><br  \/><\/p>\n<section style=\"white-space: normal;box-sizing: border-box;\" >\n<section style=\"padding-right: 13px;margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"border-width: 1px 3px 1px 1px;border-style: solid;border-color: rgb(192, 200, 209) rgb(169, 178, 54) rgb(192, 200, 209) rgb(192, 200, 209);padding: 10px;border-radius: 0px 1.5em;margin-top: -1.55em;box-sizing: border-box;box-shadow: 0px 0px 10px rgb(170,170,170);background-color: rgb(250, 250, 239);\">\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"text-align: center;color: rgb(51, 51, 51);box-sizing: border-box;\">\n<p style=\"text-align: left;\"><strong>\u6458\u8981\uff1a<\/strong>\u672c\u6587\u4ee5\u65e5\u672c\u521b\u65b0\u836f\u7269\u7684\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u4e3a\u7814\u7a76\u5bf9\u8c61\uff0c\u5206\u6790\u76ee\u524d\u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u73b0\u72b6\uff0c\u5e76\u7ed3\u5408\u91cf\u5316\u6570\u636e\u63a2\u8ba8\u653f\u7b56\u5b9e\u65bd\u6548\u679c\u3002\u7ed3\u679c\u663e\u793a\uff0c\u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u5728\u63d0\u5347\u65b0\u836f\u7684\u4e0a\u5e02\u901f\u5ea6\u3001\u4e0a\u5e02\u6570\u91cf\u53ca\u4e34\u5e8a\u4ef7\u503c\u65b9\u9762\u5747\u4ea7\u751f\u4e86\u663e\u8457\u6548\u679c\uff0c\u6fc0\u53d1\u4e86\u5236\u836f\u4f01\u4e1a\u7684\u521b\u65b0\u70ed\u60c5\uff0c\u4fdd\u969c\u4e86\u516c\u4f17\u7528\u836f\u9700\u6c42\uff0c\u5e76\u5f15\u5bfc\u4e86\u4ea7\u4e1a\u5bf9\u4e8e\u836f\u54c1\u793e\u4f1a\u6548\u76ca\u7684\u5173\u6ce8\u3002\u5efa\u8bae\u6211\u56fd\u4ece\u6784\u5efa\u591a\u79cd\u7279\u6b8a\u5ba1\u8bc4\u901a\u9053\uff0c\u660e\u786e\u4e13\u5bb6\u5ba1\u8bae\u7684\u6cd5\u5f8b\u5730\u4f4d\u53ca\u5b8c\u5584\u6c9f\u901a\u54a8\u8be2\u4f53\u7cfb\u7684\u5efa\u8bbe\u4e09\u65b9\u9762\uff0c\u5bf9\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u8fdb\u884c\u8c03\u6574\u548c\u5b8c\u5584\u3002<br  \/><\/p>\n<p style=\"text-align: left;\"><strong>\u5173\u952e\u8bcd\uff1a<\/strong>\u521b\u65b0\u836f\u7269\uff1b\u5ba1\u6279\uff1b\u5b9e\u65bd\u6548\u679c<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"border-radius: 50%;width: 6px;height: 6px;margin-top: -1px;margin-right: -2px;margin-left: auto;box-sizing: border-box;background-color: rgb(169, 178, 54);\"><\/section>\n<\/section>\n<\/section>\n<section style=\"white-space: normal;box-sizing: border-box;\" >\n<section style=\"text-align: center;margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"vertical-align: middle;display: inline-block;box-sizing: border-box;\">\n<section style=\"margin-bottom: -8px;box-sizing: border-box;\">\n<section style=\"width: 3px;height: 8px;float: left;box-sizing: border-box;background-color: rgb(188, 169, 93);\"><\/section>\n<section style=\"width: 3px;height: 8px;float: left;box-sizing: border-box;background-color: rgb(188, 169, 93);\"><br  \/><\/section>\n<section style=\"width: 3px;height: 8px;float: left;box-sizing: border-box;background-color: rgb(188, 169, 93);\"><br  \/><\/section>\n<section style=\"width: 3px;height: 8px;float: right;box-sizing: border-box;background-color: rgb(188, 169, 93);\"><\/section>\n<section style=\"clear: both;box-sizing: border-box;\"><\/section>\n<\/section>\n<section style=\"border-color: rgb(188, 169, 93);padding-right: 8px;padding-left: 8px;font-size: 18px;border-top-width: 3px;border-bottom-width: 3px;border-top-style: solid;border-bottom-style: solid;box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u4ee5\u4e0b\u4e3a\u6587\u7ae0\u8282\u9009<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p><br  \/><\/p>\n<p style=\"text-indent: 2em;\">\u5728\u5168\u7403\u77e5\u8bc6\u6280\u672f\u521b\u65b0\u6d6a\u6f6e\u63a8\u52a8\u4ee5\u53ca\u56fd\u5bb6\u201c\u5341\u4e09\u4e94\u201d\u521b\u65b0\u9a71\u52a8\u53d1\u5c55\u6218\u7565\u7684\u8981\u6c42\u4e0b\uff0c\u521b\u65b0\u836f\u7269\u7814\u53d1\u5df2\u6210\u4e3a\u652f\u6491\u533b\u836f\u4ea7\u4e1a\u53d1\u5c55\u548c\u6ee1\u8db3\u4eba\u6c11\u5065\u5eb7\u9700\u6c42\u7684\u5173\u952e[1]\u3002\u968f\u7740\u6211\u56fd\u65bd\u884c\u4e24\u5e74\u6709\u4f59\u7684\u836f\u54c1\u533b\u7597\u5668\u68b0\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u6539\u9769\u7684\u4e0d\u65ad\u5ef6\u7eed\u548c\u6df1\u5316\uff0c\u201c\u521b\u65b0\u201d\u518d\u4e00\u6b21\u88ab\u660e\u786e\u548c\u5f3a\u8c03\u4e3a\u653f\u7b56\u8c03\u6574\u4e0e\u4ea7\u4e1a\u53d1\u5c55\u7684\u6838\u5fc3\u76ee\u6807\u3002\u800c\u6211\u56fd\u533b\u836f\u4ea7\u4e1a\u57fa\u7840\u76f8\u5bf9\u8584\u5f31\uff0c\u521b\u65b0\u76d1\u7ba1\u7406\u5ff5\u4e5f\u5904\u4e8e\u521d\u6b65\u840c\u82bd\u9636\u6bb5\u3002\u5c3d\u7ba1\u5404\u9879\u6539\u9769\u653f\u7b56\u7684\u63d0\u51fa\u5177\u6709\u7b26\u5408\u5f53\u4e0b\u65f6\u4ee3\u80cc\u666f\u4e0e\u672c\u56fd\u56fd\u60c5\u7684\u4f18\u8d8a\u6027\uff0c\u53ef\u9762\u4e34\u7740\u590d\u6742\u591a\u53d8\u7684\u4ea7\u4e1a\u73af\u5883\u4e0e\u65e5\u76ca\u52a0\u5267\u7684\u56fd\u9645\u7ade\u4e89\uff0c\u4ecd\u9700\u4ee5\u66f4\u5f00\u62d3\u7684\u89c6\u89d2\u6c72\u53d6\u56fd\u9645\u5148\u8fdb\u7684\u76d1\u7ba1\u7406\u5ff5\u4e0e\u5b9e\u8df5\u7ecf\u9a8c\uff0c\u4ee5\u5c3d\u53ef\u80fd\u9884\u9632\u548c\u89c4\u907f\u653f\u7b56\u843d\u5b9e\u8fc7\u7a0b\u4e2d\u53ef\u80fd\u51fa\u73b0\u7684\u73b0\u5b9e\u95ee\u9898\u3002<\/p>\n<p style=\"text-indent: 2em;\"><br  \/><\/p>\n<p><strong>1 \u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u73b0\u72b6<\/strong><\/p>\n<p style=\"text-indent: 2em;\">\u65e5\u672c\u81ea1938 \u5e74\u8bbe\u7f6e\u539a\u751f\u7701\u5f00\u59cb\u5bf9\u836f\u54c1\u5b9e\u884c\u5168\u9762\u7cfb\u7edf\u7684\u76d1\u7ba1\u3002\u5728\u4e8c\u6218\u671f\u95f4\u4f24\u4ea1\u4e25\u91cd\u3001\u75be\u75c5\u9891\u53d1\u3001\u516c\u5171\u536b\u751f\u9700\u6c42\u9aa4\u589e\u7684\u80cc\u666f\u4e0b\uff0c\u76d1\u7ba1\u653f\u7b56\u7684\u521d\u671f\u76ee\u6807\u4ec5\u4e3a\u7b80\u5355\u7684\u91c7\u53d6\u884c\u653f\u7ba1\u5236\u624b\u6bb5\u89c4\u8303\u836f\u54c1\u5e02\u573a\uff0c\u4ee5\u63d0\u5347\u836f\u54c1\u53ef\u53ca\u6027\u3001\u4fdd\u969c\u836f\u54c1\u5b89\u5168\u3002\u968f\u7740\u6218\u540e\u533b\u836f\u4ea7\u4e1a\u6280\u672f\u6c34\u5e73\u7684\u6301\u7eed\u63d0\u5347\u4e0e\u4ea7\u4e1a\u89c4\u6a21\u7684\u8fc5\u901f\u6269\u5927\uff0c\u65e5\u672c\u653f\u5e9c\u4ee51960 \u5e74\u9881\u5e03\u7684\u300a\u836f\u4e8b\u6cd5\u300b(Pharmaceutical Affairs Law\uff0cPAL) \u4e3a\u6838\u5fc3\uff0c\u5f00\u59cb\u5bf9\u836f\u54c1\u4e0a\u5e02\u8fdb\u884c\u5ba1\u6279\u30021979\u30011983\u30011997 \u5e74\u65e5\u672c\u653f\u5e9c\u5206\u522b\u5c31PAL\u4e2d\u7684\u836f\u54c1\u4e34\u5e8a\u8bd5\u9a8c\u76f8\u5173\u8981\u6c42\u3001\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c\u53ca\u6ce8\u518c\u5ba1\u8bc4\u673a\u6784\u7b49\u65b9\u9762\u8fdb\u884c\u4e86\u8c03\u6574\uff0c\u5728\u7406\u987a\u5ba1\u8bc4\u8d44\u6e90\u7684\u540c\u65f6\u9010\u6b65\u8d2f\u5f7b\u548c\u52a0\u5f3a\u5bf9\u836f\u7269\u521b\u65b0\u7684\u6fc0\u52b1\u6548\u7528\u3002<\/p>\n<p style=\"text-indent: 2em;\"><br  \/><\/p>\n<p><strong>1.1 \u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u4f53\u7cfb<\/strong><\/p>\n<p style=\"text-indent: 2em;\">\u65e5\u672c\u7684\u836f\u54c1\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u7ecf\u5386\u4e86\u534a\u4e2a\u591a\u4e16\u7eaa\u7684\u53d1\u5c55\uff0c\u7ecf\u8fc7\u591a\u6b21\u7684\u5b8c\u5584\u548c\u8c03\u6574\uff0c\u5df2\u5f62\u6210\u9ad8\u6548\u7cfb\u7edf\u3001\u5404\u53f8\u5176\u804c\u7684\u76d1\u7ba1\u4f53\u7cfb\u3002\u76ee\u524d\uff0c\u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u8bc4\u5ba1\u6279\u76f8\u5173\u7684\u54a8\u8be2\u7ba1\u7406\u5de5\u4f5c\u5747\u7531PMDA \u72ec\u7acb\u8d1f\u8d23\u3002PMDA \u4e0b\u8bbe25 \u4e2a\u90e8\u95e8\uff0c6 \u4e2a\u5c0f\u7ec4\u53ca\u5173\u897f\u3001\u540d\u53e4\u5c4b\u5206\u5c40\uff0c\u4e0e\u521b\u65b0\u836f\u7269\u4e0a\u5e02\u5ba1\u6279\u7d27\u5bc6\u76f8\u5173\u7684\u673a\u6784\u5305\u62ec\u5ba1\u67e5\u7ba1\u7406\u90e8\u3001\u5ba1\u67e5\u6267\u884c\u90e8\u3001\u4fe1\u8d56\u4fdd\u8bc1\u90e8\u4ee5\u53ca\u65b0\u836f\u2160\uff5e\u2164\u90e8\u3001\u7ec6\u80de\u4e0e\u7ec4\u7ec7\u4ea7\u54c1\u90e8\u7b49\u804c\u80fd\u90e8\u95e8\u3002\u5404\u90e8\u95e8\u5728\u4e0d\u540c\u9636\u6bb5\u4f9d\u636e\u81ea\u8eab\u804c\u80fd\u53c2\u4e0e\u5230\u5177\u4f53\u7684\u6570\u636e\u4fe1\u8d56\u6027\u8c03\u67e5\u3001GMP \u68c0\u67e5\u6216\u6280\u672f\u5ba1\u8bc4\u5de5\u4f5c\u4e2d\uff0c\u6709\u5e8f\u5730\u63a8\u8fdb\u5ba1\u8bc4\u5de5\u4f5c\u7684\u6700\u7ec8\u5b8c\u6210\u3002\u53e6\u4e00\u53d1\u6325\u91cd\u8981\u4f5c\u7528\u7684\u673a\u6784\u4e3aMHLW \u4e0b\u8bbe\u7684\u836f\u4e8b\u4e0e\u98df\u54c1\u536b\u751f\u5ba1\u8bae\u4f1a(Pharmaceutical Affairs and Food Sanitation Council\uff0cPAFSC)\u3002PAFSC \u603b\u4f1a\u4e0b\u8bbe\u836f\u4e8b\u5206\u79d1\u4f1a\u4e0e\u98df\u54c1\u536b\u751f\u5206\u79d1\u4f1a\uff0c\u5176\u4e2d\u7684\u836f\u4e8b\u5206\u79d1\u4f1a\u8d1f\u8d23\u5bf9\u836f\u54c1\u7b49\u9886\u57df\u91cd\u5927\u95ee\u9898\u7684\u5ba1\u67e5\u548c\u8ba8\u8bba\uff0c\u4ee5\u53ca\u91cd\u8981\u836f\u5b66\u95ee\u9898\u7684\u68c0\u9a8c\u4e0e\u8bc4\u4ef7\u3002\u6700\u7ec8\u7684\u4e0a\u5e02\u8bb8\u53ef\u51b3\u5b9a\u5219\u7531MHLW \u7ed3\u5408PMDA\u7684\u5ba1\u67e5\u7ed3\u679c\u4e0ePAFSC \u63d0\u4f9b\u7684\u4e13\u5bb6\u610f\u89c1\u505a\u51fa\u3002<\/p>\n<p style=\"text-indent: 2em;\"><br  \/><\/p>\n<p style=\"text-align: center;\"><img style=\"width: auto !important;height: auto !important;visibility: visible !important;\"       src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/07\/beepress5-1532672356.jpeg\" alt=\"\u5e72\u8d27 | \u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u53ca\u5176\u5b9e\u65bd\u6548\u679c\u7814\u7a76\" title=\"\u5e72\u8d27 | \u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u53ca\u5176\u5b9e\u65bd\u6548\u679c\u7814\u7a76\"  \/><\/p>\n<p><br  \/><\/p>\n<p><strong>1.2 \u521b\u65b0\u836f\u7269\u4e0a\u5e02\u5ba1\u6279\u6d41\u7a0b<\/strong><\/p>\n<p style=\"text-indent: 2em;\">\u65e5\u672c\u836f\u54c1\u5ba1\u6279\u7a0b\u5e8f\u56e0\u5904\u65b9\u836f\u3001\u975e\u5904\u65b9\u836f\u7b49\u836f\u54c1\u7c7b\u522b\u7684\u4e0d\u540c\u800c\u6709\u6240\u533a\u5206\uff0c\u521b\u65b0\u836f\u7269\u4e00\u822c\u4f9d\u7167\u5904\u65b9\u836f\u5206\u7c7b\u4e2d\u65b0\u836f\u6807\u51c6\u5ba1\u6279\u6d41\u7a0b\u8fdb\u884c\u5ba1\u6279( \u56fe2)\u3002PMDA\u6536\u5230\u7533\u62a5\u8005\u63d0\u4ea4\u7684\u6750\u6599\u540e\uff0c\u9996\u5148\u4f1a\u8fdb\u884c\u4e00\u9879\u201c\u4fe1\u8d56\u6027\u8c03\u67e5\u201d\uff0c\u786e\u4fdd\u6240\u63d0\u4ea4\u7684\u6750\u6599\u662f\u7b26\u5408\u4f26\u7406\u5e76\u53ef\u4ee5\u79d1\u5b66\u4fe1\u8d56\u7684\uff1b\u6b64\u540e\u5ba1\u8bc4\u4eba\u5458\u5c31\u76f8\u5173\u95ee\u9898\u4e0e\u7533\u62a5\u8005\u8fdb\u884c\u9762\u8c08( \u4ecb\u7ecd\u3001\u8be2\u95ee\u3001\u7b54\u590d)\uff0c\u7533\u62a5\u8005\u987b\u5c31PMDA \u7684\u8d28\u8be2\u505a\u51fa\u89e3\u91ca\u8bf4\u660e\u3002\u901a\u8fc7\u6750\u6599\u5ba1\u67e5\u540e\uff0cPMDA \u7ec4\u7ec7\u751f\u547d\u79d1\u5b66\u3001\u533b\u5b66\u3001\u517d\u533b\u5b66\u3001\u7269\u7406\u79d1\u5b66\u3001\u751f\u7269\u7edf\u8ba1\u5b66\u7b49\u5404\u9886\u57df\u4e13\u5bb6\u4e3a\u8bc4\u5ba1\u5c0f\u7ec4\uff0c\u4ece\u62df\u4e0a\u5e02\u836f\u54c1\u7684\u8d28\u91cf\u3001\u836f\u7406\u5b66\u3001\u836f\u7269\u52a8\u529b\u5b66\u3001\u6bd2\u7406\u5b66\u3001\u4e34\u5e8a\u610f\u4e49\u53ca\u751f\u7269\u7edf\u8ba1\u5b66\u7b49\u65b9\u9762\u5f00\u5c55\u8be6\u7ec6\u7684\u8bc4\u4f30\u548c\u5ba1\u8bc4\u5de5\u4f5c\u3002\u7ecf\u8fc7\u591a\u6b21\u4e13\u5bb6\u4f1a\u8bae\u8bc4\u5ba1\u3001\u53cd\u590d\u8ba8\u8bba\u5173\u952e\u95ee\u9898\u3001\u5f62\u6210\u6700\u7ec8\u7684\u5ba1\u8bc4\u62a5\u544a\uff0cPMDA \u5c06GMP \u68c0\u67e5\u7ed3\u679c\u53ca\u8bc4\u5ba1\u62a5\u544a\u4e00\u5e76\u9012\u4ea4\u7ed9MHLW \u7684\u5ba1\u67e5\u7ba1\u7406\u79d1\uff1b\u5728\u8fd9\u4e00\u9636\u6bb5\uff0c\u9488\u5bf9\u4e00\u4e9b\u89c4\u5b9a\u54c1\u79cd\uff0cMHLW \u4f1a\u6839\u636e\u76f8\u5173\u8981\u6c42\u5411PAFSC\u8fdb\u4e00\u6b65\u5f81\u8be2\u4e13\u5bb6\u610f\u89c1\uff0c\u5e76\u7ed3\u5408\u6280\u672f\u5ba1\u8bc4\u62a5\u544a\u548c\u4e13\u5bb6\u610f\u89c1\u505a\u51fa\u662f\u5426\u6279\u51c6\u836f\u54c1\u4e0a\u5e02\u7684\u6700\u7ec8\u51b3\u5b9a\u3002<\/p>\n<p style=\"text-indent: 2em;\"><br  \/><\/p>\n<p style=\"text-align: center;\"><img style=\"width: auto !important;height: auto !important;visibility: visible !important;\"       src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/07\/beepress7-1532672356-1.jpeg\" alt=\"\u5e72\u8d27 | \u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u53ca\u5176\u5b9e\u65bd\u6548\u679c\u7814\u7a76\" title=\"\u5e72\u8d27 | \u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u53ca\u5176\u5b9e\u65bd\u6548\u679c\u7814\u7a76\"  \/><\/p>\n<p style=\"text-align: center;\"><br  \/><\/p>\n<p><strong>1.3 \u521b\u65b0\u836f\u7269\u5ba1\u6279\u4fc3\u8fdb\u653f\u7b56<\/strong><\/p>\n<p style=\"text-indent: 2em;\">\u5728\u836f\u7269\u7814\u53d1\u5230\u4e0a\u5e02\u7684\u7cfb\u5217\u73af\u8282\u4e2d\uff0c\u4ee5\u4e34\u5e8a\u8bd5\u9a8c\u548c\u4e0a\u5e02\u5ba1\u6279\u6240\u8017\u65f6\u95f4\u6700\u957f[6]\uff0c\u5982\u4f55\u4e3a\u65b0\u836f\u7684\u4e0a\u5e02\u5ba1\u6279\u63d0\u4f9b\u826f\u597d\u7684\u653f\u7b56\u652f\u6301\uff0c\u4e00\u76f4\u662f\u65e5\u672c\u653f\u5e9c\u6240\u5173\u6ce8\u7684\u6838\u5fc3\u3002\u5728\u5b8c\u5584\u7684\u5ba1\u8bc4\u4f53\u7cfb\u548c\u6e05\u6670\u7684\u5ba1\u6279\u6d41\u7a0b\u7684\u57fa\u7840\u4e0a\uff0c\u65e5\u672c\u653f\u5e9c\u540c\u65f6\u51fa\u53f0\u4e86\u76f8\u5173\u914d\u5957\u653f\u7b56\u4ee5\u4fc3\u8fdb\u673a\u6784\u804c\u80fd\u7684\u9ad8\u6548\u8fd0\u8f6c\u548c\u5ba1\u8bc4\u6d41\u7a0b\u7684\u9ad8\u6548\u63a8\u8fdb\uff0c\u8fdb\u4e00\u6b65\u53d1\u6325\u5bf9\u4f01\u4e1a\u65b0\u836f\u7814\u5236\u7684\u521b\u65b0\u6fc0\u52b1\u6548\u7528\u3002<\/p>\n<p style=\"text-indent: 2em;\"><br  \/><\/p>\n<p><strong>1.3.1 \u8bbe\u7f6e\u591a\u79cd\u6a21\u5f0f\u7684\u65b0\u836f\u5ba1\u6279\u9014\u5f84\uff0c\u52a0\u901f\u836f\u54c1\u4e0a\u5e02\u8fdb\u7a0b<\/strong><\/p>\n<p style=\"text-indent: 2em;\">\u5c3d\u7ba1\u65b0\u836f\u6807\u51c6\u5ba1\u6279\u9700\u7ecf\u5386\u7ec6\u81f4\u4e25\u683c\u7684\u5ba1\u67e5\u8fc7\u7a0b\uff0c\u65e5\u672c\u653f\u5e9c\u9488\u5bf9\u521b\u65b0\u7a0b\u5ea6\u9ad8\u3001\u75be\u75c5\u4e25\u91cd\u6027\u5f3a\u3001\u4e34\u5e8a\u9700\u6c42\u5927\u7684\u836f\u54c1\uff0c\u5f00\u8f9f\u4e86\u4f18\u5148\u5ba1\u6279( \u512a\u5148\u5be9\u67fb\uff0cpriority review)\u3001\u4f8b\u5916\u5ba1\u6279( \u7279\u4f8b\u627f\u8a8d\uff0crestrictive approval)\u3001\u65f6\u95f4\u9650\u5236\u6027\u6761\u4ef6\u5ba1\u6279( \u6761\u4ef6\u4ed8\u65e9\u671f\u627f\u8a8d\uff0ctime-limited conditional approval)3 \u79cd\u7279\u6b8a\u5ba1\u8bc4\u6a21\u5f0f\u3002\u5df2\u83b7\u5f97\u8d44\u683c\u8ba4\u5b9a\u6216\u8fbe\u5230\u76f8\u5173\u8981\u6c42\u7684\u521b\u65b0\u836f\u54c1\uff0c\u53ef\u9488\u5bf9\u6027\u5730\u9009\u62e9\u6700\u4e3a\u9002\u5b9c\u7684\u65b9\u5f0f\u5b9e\u73b0\u836f\u54c1\u7684\u5feb\u901f\u4e0a\u5e02\u3002\u9488\u5bf9\u5177\u6709\u7a81\u7834\u6027\u4ef7\u503c\u7684\u65b0\u836f\uff0c\u66f4\u53ef\u901a\u8fc7\u591a\u6a21\u5f0f\u8054\u7528\u5f3a\u5316\u6fc0\u52b1\u6548\u5e94\uff0c\u6700\u7ec8\u8fbe\u5230\u4fc3\u8fdb\u4e34\u5e8a\u9ad8\u4ef7\u503c\u836f\u54c1\u5c3d\u5feb\u4e0a\u5e02\u7684\u76ee\u7684[7]\u3002<\/p>\n<p style=\"text-indent: 2em;\"><br  \/><\/p>\n<p style=\"text-align: center;\"><img style=\"width: auto !important;height: auto !important;visibility: visible !important;\"       src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/07\/beepress1-1532672356.jpeg\" alt=\"\u5e72\u8d27 | \u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u53ca\u5176\u5b9e\u65bd\u6548\u679c\u7814\u7a76\" title=\"\u5e72\u8d27 | \u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u53ca\u5176\u5b9e\u65bd\u6548\u679c\u7814\u7a76\"  \/><\/p>\n<p><br  \/><\/p>\n<p><strong>1.3.2 \u63d0\u4f9b\u8986\u76d6\u5168\u7a0b\u7684\u6c9f\u901a\u54a8\u8be2\u4e1a\u52a1\uff0c\u964d\u4f4e\u7814\u53d1\u521b\u65b0\u6210\u672c<\/strong><\/p>\n<p style=\"text-indent: 2em;\">PMDA \u5bf9\u836f\u54c1\u6ce8\u518c\u5ba1\u6279\u5f15\u5165\u4e86\u5168\u9762\u8be6\u5c3d\u7684\u54a8\u8be2\u4e1a\u52a1\uff0c\u786e\u4fdd\u4f01\u4e1a\u4ece\u836f\u54c1\u7814\u53d1\u5230\u4e0a\u5e02\u7684\u4efb\u4f55\u65f6\u95f4\u8282\u70b9\uff0c\u5747\u53ef\u9488\u5bf9\u4e34\u5e8a\u8bd5\u9a8c\u6216\u6ce8\u518c\u5ba1\u6279\u4e8b\u9879\u5411\u4e13\u804c\u5ba1\u8bc4\u4eba\u5458\u54a8\u8be2\uff0c\u4e5f\u53ef\u5c31\u4f18\u5148\u5ba1\u8bc4\/ \u65f6\u95f4\u9650\u5236\u6027\u6761\u4ef6\u5ba1\u6279\u7684\u9002\u7528\u6027\u3001\u836f\u7269\u57fa\u56e0\u7ec4\u5b66\u6807\u8bb0\/ \u751f\u7269\u6807\u8bb0\u7269\u3001\u836f\u54c1\u8f7b\u5fae\u53d8\u66f4\u5907\u6848\u7533\u8bf7\u3001\u65b0\u836f\u7533\u8bf7\u7535\u5b50\u6570\u636e\u63d0\u4ea4\u3001GLP\/GCP\/GPSP\u3001\u836f\u54c1\u5408\u89c4\u6027\u6807\u51c6\u7b49\u5177\u4f53\u4e8b\u9879\u7533\u8bf7\u6307\u5bfc\u548c\u5efa\u8bae( \u88681)\u3002\u5404\u9879\u4e1a\u52a1\u7684\u5185\u5bb9\u3001\u8d39\u7528\u53ca\u7533\u8bf7\u7a0b\u5e8f\u3001\u5904\u7406\u60c5\u51b5\u7b49\u5747\u5728PMDA \u7f51\u7ad9\u4e0a\u4e88\u4ee5\u516c\u5e03\uff0c\u4f01\u4e1a\u53ef\u65b9\u4fbf\u3001\u5feb\u6377\u5730\u83b7\u5f97\u6240\u6709\u54a8\u8be2\u9879\u76ee\u7684\u8be6\u7ec6\u4fe1\u606f\u3002<\/p>\n<p style=\"text-indent: 2em;\"><br  \/><\/p>\n<p><img style=\"width: auto !important;height: auto !important;visibility: visible !important;\"         src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/07\/beepress0-1532672356.jpeg\" alt=\"\u5e72\u8d27 | \u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u53ca\u5176\u5b9e\u65bd\u6548\u679c\u7814\u7a76\" title=\"\u5e72\u8d27 | \u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u53ca\u5176\u5b9e\u65bd\u6548\u679c\u7814\u7a76\"  \/><\/p>\n<p><br  \/><\/p>\n<p><strong>2 \u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u7684\u5b9e\u65bd\u6548\u679c<\/strong><\/p>\n<p style=\"text-indent: 2em;\">\u968f\u7740\u65e5\u672c\u5ba1\u6279\u7ba1\u7406\u4f53\u5236\u7684\u9010\u6b65\u5b8c\u5584\u4e0e\u826f\u6027\u653f\u7b56\u73af\u5883\u7684\u5f62\u6210\uff0c\u5728\u591a\u79cd\u521b\u65b0\u836f\u7269\u5ba1\u6279\u4fc3\u8fdb\u673a\u5236\u7684\u4f5c\u7528\u4e0b\uff0c\u65e5\u672c\u521b\u65b0\u836f\u7269\u7684\u4e0a\u5e02\u901f\u5ea6\u3001\u4e0a\u5e02\u6570\u91cf\u53ca\u836f\u54c1\u4e34\u5e8a\u4ef7\u503c\u7b49\u65b9\u9762\u5747\u5448\u73b0\u51fa\u663e\u8457\u7684\u63d0\u5347\u6548\u679c\uff0c\u5728\u786e\u4fdd\u516c\u4f17\u7528\u836f\u53ef\u53ca\u6027\u7684\u540c\u65f6\uff0c\u7a33\u6b65\u63a8\u8fdb\u65e5\u672c\u533b\u836f\u4ea7\u4e1a\u7684\u8f6c\u578b\u5347\u7ea7\u4e0e\u521b\u65b0\u53d1\u5c55\u3002<\/p>\n<p style=\"text-indent: 2em;\"><br  \/><\/p>\n<p><strong>2.1 \u521b\u65b0\u836f\u7269\u4e0a\u5e02\u901f\u5ea6\u5927\u5e45\u63d0\u5347<\/strong><\/p>\n<p style=\"text-indent: 2em;\">\u521b\u65b0\u836f\u7269\u7684\u4e0a\u5e02\u901f\u5ea6\u662f\u6ce8\u518c\u5ba1\u6279\u7cfb\u7edf\u8fd0\u884c\u6548\u7387\u7684\u76f4\u89c2\u4f53\u73b0\uff0c\u66f4\u662f\u5f71\u54cd\u4f01\u4e1a\u7814\u53d1\u6210\u672c\u56de\u6536\u4e0e\u521b\u65b0\u6210\u679c\u8f6c\u5316\u7684\u5173\u952e\u56e0\u7d20\u30022004 \u5e74\u5ba1\u6279\u7ba1\u7406\u4f53\u7cfb\u91cd\u5efa\u4e4b\u521d\uff0c\u65e5\u672c\u65b0\u836f\u6807\u51c6\u5ba1\u6279\u5468\u671f\u957f\u8fbe21.9 \u4e2a\u6708[10]\uff0c\u4f01\u4e1a\u5728\u7ecf\u5386\u9ad8\u6295\u5165\u4e0e\u957f\u5468\u671f\u7684\u65b0\u836f\u7814\u53d1\u9636\u6bb5\u540e\u4ecd\u9700\u7b49\u5f85\u6f2b\u957f\u7684\u5ba1\u8bc4\u65f6\u95f4\uff0c\u4f7f\u5f97\u8bf8\u591a\u4f01\u4e1a\u5bf9\u6b64\u671b\u800c\u5374\u6b65\u3002\u968f\u7740\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u7684\u5b8c\u5584\u4e0e\u5ba1\u8bc4\u8d44\u6e90\u7684\u589e\u52a0\uff0c\u65b0\u836f\u5ba1\u6279\u65f6\u95f4\u663e\u8457\u7f29\u77ed\uff0c2014 \u5e74PMDA \u5bf9\u65b0\u5316\u5b66\u5b9e\u4f53(new active substance, NAS) \u7684\u5e73\u5747\u5ba1\u6279\u65f6\u95f4\u4e3a306 d\uff0c\u8d85\u8d8aFDA 343 d \u7684\u5e73\u5747\u5ba1\u6279\u65f6\u957f\u6210\u4e3a\u56fd\u9645\u4e0a\u5ba1\u6279\u6548\u7387\u6700\u9ad8\u7684\u673a\u6784[11]\u3002\u76ee\u524d\u65e5\u672c\u4ecd\u5728\u56fd\u9645\u4e0a\u4fdd\u6301\u5176\u65b0\u836f\u5ba1\u6279\u901f\u5ea6\u65b9\u9762\u7684\u4f18\u52bf\u5730\u4f4d\uff0c\u6301\u7eed\u9ad8\u6548\u5730\u6279\u51c6\u521b\u65b0\u836f\u7269\u7684\u4e0a\u5e02( \u56fe4\uff0c\u6570\u636e\u6765\u6e90\uff1aCentre for Innovation in Regulatory Science)\u3002<\/p>\n<p style=\"text-indent: 2em;\"><br  \/><\/p>\n<p style=\"text-align: center;\"><img style=\"width: auto !important;height: auto !important;visibility: visible !important;\"       src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/07\/beepress0-1532672356-1.jpeg\" alt=\"\u5e72\u8d27 | \u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u53ca\u5176\u5b9e\u65bd\u6548\u679c\u7814\u7a76\" title=\"\u5e72\u8d27 | \u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u53ca\u5176\u5b9e\u65bd\u6548\u679c\u7814\u7a76\"  \/><\/p>\n<p style=\"text-align: center;\"><br  \/><\/p>\n<p><strong>2.2 \u521b\u65b0\u836f\u7269\u4e0a\u5e02\u6570\u91cf\u663e\u8457\u589e\u52a0<\/strong><\/p>\n<p style=\"text-indent: 2em;\">\u836f\u54c1\u4e0a\u5e02\u6570\u91cf\u548c\u79cd\u7c7b\u8d8a\u591a\uff0c\u836f\u54c1\u7684\u53ef\u66ff\u4ee3\u6027\u53ca\u81ea\u7ed9\u7a0b\u5ea6\u5c31\u8d8a\u9ad8\uff0c\u60a3\u8005\u5bf9\u836f\u54c1\u7684\u53ef\u83b7\u5f97\u6027\u4e5f\u5c31\u8d8a\u5f3a[12]\u3002\u5c3d\u7ba1\u5728\u6bcf\u5e74\u5168\u7403\u7814\u53d1\u60c5\u52bf\u5dee\u5f02\u4e0b\u65e5\u672c\u65b0\u836f\u4e0a\u5e02\u6570\u91cf\u9010\u5e74\u6709\u6240\u6ce2\u52a8\uff0c\u4f46\u603b\u4f53\u6765\u770b\u4ecd\u5448\u73b0\u660e\u663e\u7684\u4e0a\u5347\u8d8b\u52bf\uff0c2012\u20142016 \u5e74NAS \u6279\u51c6\u4e0a\u5e02\u6570\u91cf\u76f8\u6bd42007\u20142011 \u5e74\u589e\u5e45\u9ad8\u8fbe42\uff05 ( \u56fe5\uff0c\u6570\u636e\u6765\u6e90\uff1aCentre for Innovation in Regulatory Science)[11]\u30022016 \u5e74PMDA \u5171\u6279\u51c648 \u4e2aNAS \u4e0a\u5e02\uff0c\u51e0\u4e4e\u53cc\u500d\u4e8e\u540c\u5e74\u7f8e\u56fd22 \u4e2a\u548c\u6b27\u76df28 \u4e2a\u7684NAS \u4e0a\u5e02\u6570\u91cf\uff1b\u65b0\u751f\u7269\u5236\u54c1\u4e0a\u5e02\u6570\u91cf\u4e5f\u9ad8\u8fbe11 \u4e2a\uff0c\u5305\u62ec\u5355\u6297\u3001\u91cd\u7ec4\u51dd\u8840\u56e0\u5b50\u548c\u9176\u7b49[13]\u3002\u7531\u6b64\u53ef\u89c1\uff0c\u516c\u4f17\u5bf9\u4e8e\u5316\u5b66\u836f\u54c1\u548c\u751f\u7269\u836f\u54c1\u7684\u9700\u6c42\u6108\u53d1\u5f97\u5230\u66f4\u9ad8\u6c34\u5e73\u7684\u6ee1\u8db3\uff0c\u7528\u836f\u7684\u53ef\u83b7\u5f97\u6027\u5c06\u6301\u7eed\u4e0d\u65ad\u5f97\u4ee5\u63d0\u9ad8\u3002<\/p>\n<p style=\"text-indent: 2em;\"><br  \/><\/p>\n<p style=\"text-align: center;\"><img style=\"width: auto !important;height: auto !important;visibility: visible !important;\"       src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/07\/beepress6-1532672356.jpeg\" alt=\"\u5e72\u8d27 | \u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u53ca\u5176\u5b9e\u65bd\u6548\u679c\u7814\u7a76\" title=\"\u5e72\u8d27 | \u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u53ca\u5176\u5b9e\u65bd\u6548\u679c\u7814\u7a76\"  \/><\/p>\n<p style=\"text-align: center;\"><br  \/><\/p>\n<p><strong>2.3 \u9ad8\u4ef7\u503c\u521b\u65b0\u6210\u679c\u4e0d\u65ad\u4ea7\u51fa<\/strong><\/p>\n<p style=\"text-indent: 2em;\">\u968f\u7740\u65e5\u672c\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u4f53\u7cfb\u7684\u5b8c\u5584\uff0c\u5177\u6709\u4e34\u5e8a\u4ef7\u503c\u4f18\u52bf\u7684\u521b\u65b0\u836f\u7269\u66f4\u80fd\u63d0\u524d\u83b7\u5f97\u836f\u54c1\u5ba1\u8bc4\u673a\u6784\u7684\u65e9\u671f\u652f\u6301\u4e0e\u6307\u5bfc\uff0c\u8fdb\u800c\u901a\u8fc7\u7279\u6b8a\u5ba1\u6279\u9014\u5f84\u5b9e\u73b0\u5feb\u901f\u4e0a\u5e02\u3002\u5728\u4f17\u591a\u653f\u7b56\u5229\u597d\u4e0b\uff0c\u4f01\u4e1a\u66f4\u52a0\u5173\u6ce8\u4e8e\u5bf9\u9ad8\u4e34\u5e8a\u4ef7\u503c\u836f\u7269\u7684\u7814\u7a76\u5f00\u53d1\uff0c\u4e0d\u4ec5\u4fc3\u4f7f\u521b\u65b0\u4ea7\u51fa\u6570\u91cf\u7684\u589e\u52a0\uff0c\u4e5f\u4fc3\u8fdb\u4e86\u521b\u65b0\u6210\u679c\u8d28\u91cf\u7684\u63d0\u5347\uff0c\u8fd9\u4e00\u70b9\u53ef\u4ece\u83b7\u7279\u6b8a\u5ba1\u6279\u901a\u9053\u4e0a\u5e02\u7684\u836f\u7269\u6bd4\u4f8b\u6709\u6240\u53cd\u6620\u30022007 \u81f32016 \u5e74\u65e5\u672c\u6bcf\u5e74\u6240\u6279\u51c6\u7684NASs \u4e2d\uff0c\u83b7\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c\u8ba4\u5b9a\u7684\u836f\u54c1\u6bd4\u4f8b\u4ece18.52\uff05\u4e0a\u5347\u81f345.83\uff05\uff0c\u5448\u73b0\u660e\u663e\u4e0a\u5347\u8d8b\u52bf\uff0c\u53ef\u89c1\u6cbb\u7597\u5371\u91cd\u75be\u75c5\u3001\u66f4\u5177\u4e34\u5e8a\u4ef7\u503c\u7684\u521b\u65b0\u836f\u7269\u6570\u91cf\u6709\u6240\u589e\u591a( \u56fe6\uff0c\u6570\u636e\u6765\u6e90\uff1aCentre for Innovation in Regulatory Science)\u3002\u65f6\u95f4\u9650\u5236\u6027\u6761\u4ef6\u5ba1\u6279\u901a\u9053\u4ec5\u6784\u5efa\u4e24\u5e74\uff0c\u5df2\u67093 \u79cd\u518d\u751f\u533b\u7597\u4ea7\u54c1\u901a\u8fc7\u6b64\u9014\u5f84\u5b9e\u73b0\u4e0a\u5e02[14]\uff0c\u66f4\u52a0\u663e\u793a\u51fa\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u5bf9\u4f01\u4e1a\u7814\u53d1\u884c\u4e3a\u7684\u91cd\u8981\u5bfc\u5411\u4f5c\u7528\u3002<\/p>\n<p style=\"text-indent: 2em;\"><br  \/><\/p>\n<p style=\"text-align: center;\">\n<p style=\"text-align: center;\"><br  \/><\/p>\n<p><strong>3 \u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u5bf9\u6211\u56fd\u7684\u542f\u793a<\/strong><\/p>\n<p style=\"text-indent: 2em;\">\u968f\u7740\u6211\u56fd\u836f\u5ba1\u5236\u5ea6\u6539\u9769\u7684\u6301\u7eed\u63a8\u8fdb\u4e0e\u300a\u5173\u4e8e\u6df1\u5316\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u6539\u9769\u9f13\u52b1\u836f\u54c1\u533b\u7597\u5668\u68b0\u521b\u65b0\u7684\u610f\u89c1\u300b\u7b49\u7eb2\u9886\u6027\u6587\u4ef6\u7684\u76f8\u7ee7\u51fa\u53f0\uff0c\u5bf9\u4f18\u5316\u5ba1\u8bc4\u5ba1\u6279\u7a0b\u5e8f\u3001\u91ca\u653e\u4f01\u4e1a\u521b\u65b0\u6d3b\u529b\u4e5f\u63d0\u51fa\u4e86\u66f4\u9ad8\u7684\u8981\u6c42\uff0c\u5404\u9879\u653f\u7b56\u7684\u7ec6\u5316\u4e0e\u843d\u5b9e\u5c06\u662f\u4e0b\u4e00\u9636\u6bb5\u7684\u5de5\u4f5c\u91cd\u5fc3\uff0c\u66f4\u662f\u6709\u5f85\u653b\u575a\u7684\u96be\u70b9\u4e4b\u5904\u3002\u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u4f53\u7cfb\u7684\u4e0d\u65ad\u5b8c\u5584\u548c\u5404\u9879\u5ba1\u6279\u4fc3\u8fdb\u653f\u7b56\u7684\u5b9e\u65bd\u5bf9\u4e8e\u63d0\u5347\u4f01\u4e1a\u521b\u65b0\u70ed\u60c5\u3001\u63d0\u9ad8\u836f\u54c1\u53ef\u53ca\u6027\u3001\u5f15\u5bfc\u4e34\u5e8a\u4ef7\u503c\u5173\u6ce8\u65b9\u9762\u4ea7\u751f\u4e86\u663e\u8457\u7684\u6fc0\u52b1\u6548\u679c\u3002\u501f\u9274\u65e5\u672c\u7684\u5b9e\u8df5\u7ecf\u9a8c\u4e0e\u76d1\u7ba1\u601d\u8def\uff0c\u7ed3\u5408\u6211\u56fd\u5f53\u524d\u521b\u65b0\u836f\u7269\u6ce8\u518c\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u6539\u9769\u52a8\u5411\uff0c\u672c\u6587\u63d0\u51fa\u4ee5\u4e0b\u5efa\u8bae\u3002<\/p>\n<p style=\"text-indent: 2em;\"><br  \/><\/p>\n<p><strong>3.1 \u6784\u5efa\u591a\u79cd\u7279\u6b8a\u5ba1\u8bc4\u901a\u9053\uff0c\u5408\u7406\u5206\u914d\u5ba1\u8bc4\u8d44\u6e90<\/strong><\/p>\n<p style=\"text-indent: 2em;\">\u7531\u4e8e\u836f\u5ba1\u8d44\u6e90\u6709\u9650\uff0c\u5bf9\u4e0d\u540c\u6cbb\u7597\u75be\u75c5\u3001\u4e34\u5e8a\u4ef7\u503c\u3001\u521b\u65b0\u6c34\u5e73\u7684\u836f\u7269\u96be\u4ee5\u5b9e\u73b0\u5ba1\u8bc4\u8d44\u6e90\u7684\u5e73\u8861\u5206\u914d\u3002\u4e3a\u9632\u6b62\u5355\u4e00\u7279\u6b8a\u5ba1\u6279\u6a21\u5f0f\u4e0b\u5ba1\u8bc4\u8d44\u6e90\u7d27\u5f20\u3001\u4f01\u4e1a\u7533\u8bf7\u56f0\u96be\uff0c\u4ece\u800c\u803d\u6401\u9ad8\u4e34\u5e8a\u4ef7\u503c\u521b\u65b0\u836f\u54c1\u4e0a\u5e02\u7684\u60c5\u51b5\uff0c\u53ef\u6709\u6240\u4fa7\u91cd\u5730\u6784\u5efa\u591a\u5143\u5316\u3001\u5dee\u5f02\u5316\u7684\u7279\u6b8a\u5ba1\u6279\u901a\u9053\uff0c\u5c06\u6709\u9650\u7684\u5ba1\u8bc4\u8d44\u6e90\u66f4\u52a0\u7cbe\u51c6\u5730\u5411\u66f4\u5177\u4e34\u5e8a\u4f18\u52bf\u7684\u521b\u65b0\u836f\u54c1\u503e\u659c\u3002<\/p>\n<p style=\"text-indent: 2em;\"><br  \/><\/p>\n<p><strong>3.2 \u660e\u786e\u4e13\u5bb6\u5ba1\u8bae\u6cd5\u5f8b\u5730\u4f4d\uff0c\u53d1\u6325\u5916\u90e8\u4eba\u624d\u6548\u7528<\/strong><\/p>\n<p style=\"text-indent: 2em;\">\u836f\u54c1\u5ba1\u8bc4\u662f\u5bf9\u836f\u54c1\u98ce\u9669\u4e0e\u5229\u76ca\u7684\u7efc\u5408\u8bc4\u4f30\uff0c\u6d89\u53ca\u5230\u591a\u5b66\u79d1\u95e8\u7c7b\u7684\u4ea4\u53c9\uff0c\u9700\u8981\u8f83\u9ad8\u7684\u4e13\u4e1a\u6c34\u5e73\u4e0e\u4e30\u5bcc\u7684\u77e5\u8bc6\u7d20\u517b\u65b9\u53ef\u7075\u6d3b\u3001\u79d1\u5b66\u3001\u5408\u7406\u5730\u5b8c\u6210\u5ba1\u67e5\u5de5\u4f5c\u3002\u4e3a\u514b\u670d\u836f\u54c1\u5ba1\u8bc4\u673a\u6784\u5185\u90e8\u4e13\u804c\u5ba1\u8bc4\u4eba\u5458\u5728\u77e5\u8bc6\u3001\u7ecf\u9a8c\u3001\u4fe1\u606f\u4e0a\u7684\u5c40\u9650\u6027\uff0c\u53ef\u8003\u8651\u7eb3\u5165\u5916\u90e8\u591a\u4e13\u4e1a\u3001\u591a\u5b66\u79d1\u7684\u4eba\u624d\u5728\u836f\u54c1\u5ba1\u8bc4\u8fc7\u7a0b\u4e2d\u53d1\u6325\u6548\u7528\uff0c\u4ee5\u63d0\u9ad8\u5ba1\u8bc4\u6548\u7387\uff0c\u589e\u52a0\u5ba1\u8bc4\u7ed3\u679c\u7684\u79d1\u5b66\u5408\u7406\u3002<\/p>\n<p style=\"text-indent: 2em;\"><br  \/><\/p>\n<p><strong>3.3 \u5b8c\u5584\u6c9f\u901a\u54a8\u8be2\u4f53\u7cfb\u5efa\u8bbe\uff0c\u5b9e\u73b0\u65e9\u671f\u4fe1\u606f\u4ea4\u6d41<\/strong><\/p>\n<p style=\"text-indent: 2em;\">\u836f\u54c1\u7684\u4e0a\u5e02\u5ba1\u6279\u8fc7\u7a0b\u4e2d\u7814\u53d1\u7533\u62a5\u65b9\u4e0e\u76d1\u7ba1\u90e8\u95e8\u4e4b\u95f4\u4e0d\u53ef\u907f\u514d\u5b58\u5728\u4e00\u5b9a\u7684\u4fe1\u606f\u5c4f\u969c\uff0c\u76f8\u5173\u7684\u6cd5\u5f8b\u89c4\u8303\u4e0e\u6280\u672f\u6307\u5357\u4e5f\u96be\u4ee5\u6db5\u76d6\u7814\u53d1\u548c\u7533\u62a5\u8fc7\u7a0b\u4e2d\u53ef\u80fd\u9047\u5230\u7684\u6240\u6709\u95ee\u9898\u3002\u4f01\u4e1a\u901a\u8fc7\u4e0e\u836f\u5ba1\u90e8\u95e8\u4e4b\u95f4\u7684\u65e9\u671f\u6c9f\u901a\u4ea4\u6d41\uff0c\u6709\u52a9\u4e8e\u5176\u5728\u7814\u53d1\u9636\u6bb5\u5373\u4ee5\u5ba1\u8bc4\u8981\u6c42\u4e3a\u51c6\u5219\u8fdb\u884c\u836f\u7269\u7684\u8bbe\u8ba1\u5f00\u53d1\uff0c\u5728\u6b63\u5f0f\u63d0\u4ea4\u4e0a\u5e02\u7533\u8bf7\u524d\u53ef\u53ca\u65f6\u53d1\u73b0\u95ee\u9898\u5e76\u52a0\u4ee5\u4fee\u6b63\uff0c\u65e2\u964d\u4f4e\u4e86\u4f01\u4e1a\u7684\u521b\u65b0\u98ce\u9669\uff0c\u53c8\u9632\u6b62\u4e86\u4eba\u529b\u7269\u529b\u7684\u6d88\u8017\u4e0e\u6709\u9650\u5ba1\u8bc4\u8d44\u6e90\u7684\u6d6a\u8d39\u3002<\/p>\n<p style=\"text-indent: 2em;\"><br  \/><\/p>\n<p style=\"text-indent: 2em;\">\u6211\u56fd\u867d\u5df2\u51fa\u53f0\u6307\u5bfc\u836f\u7269\u7814\u53d1\u4e0e\u6280\u672f\u5ba1\u8bc4\u8fc7\u7a0b\u4e2d\u6c9f\u901a\u4ea4\u6d41\u7684\u76f8\u5173\u529e\u6cd5\uff0c\u4f46\u5c31\u76ee\u524d\u836f\u5ba1\u4e2d\u5fc3\u63d0\u4f9b\u54a8\u8be2\u7684\u60c5\u51b5\u6765\u770b\uff0c\u4ecd\u5b58\u5728\u901a\u8fc7\u7f51\u7edc\u3001\u7535\u8bdd\u3001\u90ae\u4ef6\u7b49\u54a8\u8be2\u65b9\u5f0f\u7684\u80cc\u666f\u4fe1\u606f\u638c\u63e1\u4e0d\u8db3\u3001\u54a8\u8be2\u6548\u679c\u4e0d\u5f3a\u3001\u6307\u5bfc\u610f\u4e49\u8f83\u5dee\uff1b\u73b0\u573a\u54a8\u8be2\u7684\u53ef\u83b7\u5f97\u6027\u53d7\u9650\u3001\u54a8\u8be2\u4f1a\u8bae\u79cd\u7c7b\u76f8\u5bf9\u5bbd\u6cdb\u3001\u9488\u5bf9\u6027\u4e0d\u5f3a\u7b49\u95ee\u9898\u3002\u4e3a\u5b8c\u5584\u6c9f\u901a\u54a8\u8be2\u4f53\u7cfb\uff0c\u4e00\u65b9\u9762\u9700\u8003\u8651\u6269\u5927\u63d0\u4f9b\u54a8\u8be2\u7684\u4e1a\u52a1\u8303\u7574\uff0c\u7ec6\u5316\u54a8\u8be2\u4e1a\u52a1\u79cd\u7c7b\uff0c\u66f4\u52a0\u7cbe\u51c6\u3001\u79d1\u5b66\u3001\u9ad8\u6548\u5730\u63d0\u4f9b\u54a8\u8be2\u670d\u52a1\uff1b\u53e6\u4e00\u65b9\u9762\u5e94\u8fdb\u4e00\u6b65\u89c4\u8303\u54a8\u8be2\u7533\u8bf7\u548c\u5f00\u5c55\u7684\u5177\u4f53\u6d41\u7a0b\uff0c\u5728\u54a8\u8be2\u5b8c\u6210\u540e\u5f62\u6210\u8be6\u7ec6\u7684\u8bc4\u4ef7\u62a5\u544a\u63d0\u4f9b\u7ed9\u4f01\u4e1a\u548c\u836f\u54c1\u5ba1\u8bc4\u90e8\u95e8\uff0c\u4ece\u800c\u4e3a\u4f01\u4e1a\u4e34\u5e8a\u8bd5\u9a8c\u6216\u6ce8\u518c\u7533\u8bf7\u7684\u8c03\u6574\u53ca\u76d1\u7ba1\u90e8\u95e8\u540e\u7eed\u7684\u5ba1\u67e5\u5de5\u4f5c\u63d0\u4f9b\u53c2\u8003\u3002<\/p>\n<p><br  \/><\/p>\n<p><span style=\"font-size: 14px;\">\u57fa\u91d1\u9879\u76ee\uff1a\u56fd\u5bb6\u793e\u79d1\u57fa\u91d1\u91cd\u5927\u9879\u76ee\uff1a\u6211\u56fd\u521b\u65b0\u836f\u7269\u653f\u7b56\u73af\u5883\u7814\u7a76<\/span><span style=\"font-size: 14px;\">(15ZDB167)\u3001\u56fd\u5bb6\u793e\u79d1\u57fa\u91d1\u4e00\u822c\u9879\u76ee\uff1a\u98df\u54c1\u836f\u54c1\u5b89\u5168\u534f\u540c\u6cbb\u7406\u7684\u56fd\u9645<\/span><span style=\"font-size: 14px;\">\u6bd4\u8f83\u7814\u7a76(15BZZ052)\u3001\u6c5f\u82cf\u9ad8\u6821\u54f2\u5b66\u793e\u4f1a\u79d1\u5b66\u7814\u7a76\u9879\u76ee\uff1a\u5efa\u7acb\u7f55\u89c1\u75c5<\/span><span style=\"font-size: 14px;\">\u533b\u7597\u4fdd\u9669\u5236\u5ea6\u524d\u77bb\u6027\u7814\u7a76(2014SJD084)<\/span><\/p>\n<p><span style=\"font-size: 14px;\">\u4f5c\u8005\u7b80\u4ecb\uff1a\u9648\u6c38\u6cd5(1965\u2014)\uff0c\u7537\uff0c\u6559\u6388\uff0c\u535a\u58eb\u751f\u5bfc\u5e08\uff0c\u4ece\u4e8b\u56fd\u5185\u5916<\/span><span style=\"font-size: 14px;\">\u836f\u4e8b\u6cd5\u89c4\u4e0e\u836f\u54c1\u8bc4\u4ef7\u7814\u7a76\u3002<\/span><\/p>\n<p><span style=\"font-size: 14px;\">E-mail\uff1acyf990@163.com<\/span><\/p>\n<p><span style=\"line-height: 0px;display: none;\">\u200d<\/span><\/p>\n<p><span style=\"line-height: 0px;display: none;\">\u200d<\/span><\/p>\n<blockquote class='keep-source'>\n<p>\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a                                               <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u65e5\u672c\u521b\u65b0\u836f\u7269\u5ba1\u6279\u7ba1\u7406\u653f\u7b56\u53ca\u5176\u5b9e\u65bd\u6548\u679c\u7814\u7a76 Performance of Approval Regulation [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":350,"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\/349"}],"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=349"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/349\/revisions"}],"predecessor-version":[{"id":357,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/349\/revisions\/357"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/350"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=349"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=349"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=349"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}