{"id":81680,"date":"2019-03-14T00:00:50","date_gmt":"2019-04-11T06:52:01","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/81680\/"},"modified":"2019-04-11T14:52:01","modified_gmt":"2019-04-11T06:52:01","slug":"34c4aca281","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/81680\/","title":{"rendered":"\u7f8e\u56fd\u836f\u54c1\u6ce8\u518c\u6280\u672f"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 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%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">1.1<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><\/strong><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7f8e\u56fd\u6982\u51b5<\/span><\/strong><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f8e\u56fd\u4f4d\u4e8e\u5317\u7f8e\u6d32\u4e2d\u90e8\uff0c\u5317\u4e0e\u52a0\u62ff\u5927\u63a5\u58e4\uff0c\u5357\u9760\u58a8\u897f\u54e5\u548c\u58a8\u897f\u54e5\u6e7e\uff0c\u897f\u4e34\u592a\u5e73\u6d0b\uff0c\u4e1c\u6fd2\u5927\u897f\u6d0b\uff0c\u9886\u571f\u8fd8\u5305\u62ec\u5317\u7f8e\u6d32\u897f\u5317\u90e8\u7684\u963f\u62c9\u65af\u52a0\u548c\u592a\u5e73\u6d0b\u4e2d\u90e8\u7684\u590f\u5a01\u5937\u7fa4\u5c9b\u3002\u603b\u9762\u79ef9629091\u5e73\u65b9\u516c\u91cc\uff0c\u4eba\u53e33\u4ebf\uff08\u622a\u6b622014\u5e743\u6708\uff09\u3002\u7f8e\u56fd\u5177\u6709\u9ad8\u5ea6\u53d1\u8fbe\u7684\u73b0\u4ee3\u5e02\u573a\u7ecf\u6d4e\uff0c\u5176\u56fd\u5185\u751f\u4ea7\u603b\u503c\u548c\u5bf9\u5916\u8d38\u6613\u989d\u5747\u5c45\u4e16\u754c\u9996\u4f4d\uff0c2013\u5e74\u56fd\u5185\u751f\u4ea7\u603b\u503c\uff08GDP\uff09162446\u4ebf\u7f8e\u5143\uff08\u63092013\u5e74\u5f53\u5e74\u4ef7\u683c\u8ba1\u7b97\uff09\u30022013\u5e74\u4e2d\u7f8e\u533b\u836f\u8d38\u6613\u989d\u7ea6100\u4ebf\u7f8e\u5143\uff0c\u5176\u4e2d\u5bf9\u7f8e\u51fa\u53e3\u7ea670\u4ebf\u7f8e\u5143\uff0c\u81ea\u7f8e\u8fdb\u53e3\u7ea630\u4ebf\u7f8e\u5143\u3002<\/span><\/p>\n<p 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style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 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%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">1.2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><\/strong><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7f8e\u56fd\u7684\u533b\u836f\u7ba1\u7406\u5236\u5ea6\u53ca\u673a\u6784<\/span><\/strong><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">1.2.1<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u533b\u836f\u7ba1\u7406\u6cd5\u89c4<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f8e\u56fd\u5177\u6709\u5b8c\u5584\u7684\u836f\u54c1\u76d1\u7ba1\u6cd5\u5f8b\u4f53\u7cfb\u548c\u8be6\u7ec6\u7684\u90e8\u95e8\u89c4\u7ae0\u3002\u98df\u54c1\u548c\u836f\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09\u76d1\u7ba1\u4f9d\u636e\u7684\u4e3b\u8981\u6cd5\u5f8b\u662f\u300a\u98df\u54c1\u3001\u836f\u54c1\u548c\u5316\u5986\u54c1\u6cd5\u300b\uff08Food,Drug andCosmetic, FDCA\uff09\u53ca\u5176\u4fee\u6b63\u6848\u3001\u300a\u8054\u90a6\u7ba1\u7406\u6cd5\u300b\uff08Code of Federal \uff09\u7b2c21\u4e3b\u9898\u4ee5\u53caCDER\u53d1\u8868\u7684\u7cfb\u5217\u6307\u5bfc\u6027\u6587\u4ef6\u300a\u653f\u7b56\u548c\u7a0b\u5e8f\u6307\u5357\u300b\u3001\u300a\u81b3\u98df\u8865\u5145\u5242\u4e0e\u6559\u80b2\u6cd5\u300b\uff08Dietary Supplement Health And Act\uff09\u7b49\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">1.2.2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box 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style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word 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style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u4e3a\u52a0\u5f3a\u836f\u54c1\u8d28\u91cf\u7ba1\u7406\uff0cFDA\u5c06\u5168\u56fd\u5212\u5206\u62105\u4e2a\u5927\u533a\uff0c\u5206\u522b\u4e3a\u4e1c\u5317\u533a\u3001\u4e2d\u90e8\u533a\u3001\u4e1c\u5357\u533a\u3001\u897f\u5357\u533a\u548c\u592a\u5e73\u6d0b\u533a\uff0c\u6bcf\u533a\u8bbe\u4e00\u5927\u533a\u6240\uff0c5\u4e2a\u5927\u533a\u6240\u7684\u6240\u5728\u5730\u5206\u522b\u662f\u6ce2\u58eb\u987f\u3001\u8d39\u57ce\u3001\u4e9a\u7279\u5170\u5927\u3001\u8fbe\u62c9\u65af\u548c\u65e7\u91d1\u5c71\u3002\u5927\u533a\u6240\u4e0b\u8bbe\u82e5\u5e72\u5730\u533a\u6240\uff0c\u5730\u533a\u6240\u4e0b\u8bbe\u82e5\u5e72\u5de5\u4f5c\u7ad9\uff0c\u5168\u7f8e\u76ee\u524d\u5171\u6709143\u4e2a\u5de5\u4f5c\u7ad9\u3002FDA\u603b\u90e8\u548c\u533a\u6240\u3001\u5de5\u4f5c\u7ad9\u5404\u81ea\u5c65\u884c\u4e0d\u540c\u7684\u804c\u8d23\u3002\u836f\u54c1\u7684\u6279\u51c6\u6743\u5728\u603b\u90e8\u3002\u5728\u836f\u54c1\u7533\u62a5\u65f6\uff0c\u603b\u90e8\u8d1f\u8d23\u5ba1\u67e5\u6240\u6709\u7684\u6570\u636e\u3001\u5ba1\u9605\u6240\u6709\u7684\u62a5\u6279\u6750\u6599\uff0c\u533a\u6240\u8d1f\u8d23\u786e\u8bc1\u516c\u53f8\u6240\u7533\u62a5\u7684\u6570\u636e\u8d44\u6599\u662f\u5426\u51c6\u786e\uff0c\u662f\u5426\u7b26\u5408GMP\u53caGLP\u7684\u7ba1\u7406\u89c4\u8303\u7b49\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f8e\u56fd\u5404\u5dde\u4e5f\u6309\u5730\u65b9\u6cd5\u89c4\u5bf9\u836f\u54c1\u5b9e\u65bd\u7ba1\u7406\uff0c\u4e3b\u8981\u804c\u8d23\u5305\u62ec\uff1a\u5bf9\u836f\u5e08\u8fdb\u884c\u8003\u8bd5\u548c\u6ce8\u518c\u3001\u5bf9\u836f\u54c1\u7ecf\u8425\u90e8\u95e8\u548c\u836f\u623f\u8fdb\u884c\u76d1\u7763\u68c0\u67e5\uff0c\u53d1\u653e\u6216\u6362\u53d1\u8bb8\u53ef\u8bc1\u3001\u540a\u9500\u8fdd\u6cd5\u8005\u7684\u8bb8\u53ef\u8bc1\u3001\u5bf9\u6240\u5728\u5730\u7684\u836f\u5b66\u9662\u6821\u8fdb\u884c\u8bc4\u4ef7\u3001\u5ba1\u67e5\u89c1\u4e60\u836f\u623f\u7b49\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;text-align: left;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;font-family: \u5b8b\u4f53;font-size: 12px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: center;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u56fe4-1\uff1a\u7f8e\u56fdFDA\u7ec4\u7ec7\u673a\u6784\u56fe<\/span><\/p>\n<p style=\"text-align: center;\">\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;text-align: center;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;font-family: \u5b8b\u4f53;font-size: 12px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6765\u6e90\uff1aFDA<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;text-align: left;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;font-family: \u5b8b\u4f53;font-size: 12px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 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%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">1.3<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><\/strong><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7f8e\u56fd\u836f\u54c1\u6ce8\u518c\u5236\u5ea6<\/span><\/strong><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">1.3.1<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u836f\u54c1\u5206\u7c7b<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">1.3.1.1<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5904\u65b9\u836f\u4e0e\u975e\u5904\u65b9\u836f<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f8e\u56fd\u300a\u8054\u90a6\u98df\u54c1\u3001\u836f\u54c1\u548c\u5316\u5986\u54c1\u6cd5\u300b\u628a\u836f\u54c1\u5206\u4e3a\u4e24\u5927\u7c7b\uff1a\u5904\u65b9\u836f\uff08Rx\uff09\u548c\u975e\u5904\u65b9\u836f\uff08OTC\uff09\u3002FDA\u6709\u6743\u51b3\u5b9a\u5404\u7533\u8bf7\u836f\u54c1\u7684\u5c5e\u6027\uff0c\u5728\u4e00\u5b9a\u6761\u4ef6\u4e0b\uff0c\u5904\u65b9\u836f\u548c\u975e\u5904\u65b9\u836f\u8d44\u683c\u53ef\u4ee5\u8fdb\u884c\u8f6c\u6362\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5904\u65b9\u836f\u662f\u6307\u57fa\u4e8e\u836f\u54c1\u7684\u6bd2\u6027\u6216\u5176\u4f7f\u7528\u65b9\u6cd5\u3001\u53ca\u5176\u4f7f\u7528\u836f\u54c1\u6240\u4f34\u968f\u7684\u5176\u4ed6\u6d3b\u52a8\u5b58\u5728\u6f5c\u5728\u6709\u5bb3\u6548\u679c\uff0cFDA\u8ba4\u4e3a\u672a\u7ecf\u6267\u4e1a\u533b\u5e08\u6307\u5bfc\u4f7f\u7528\u4e0d\u591f\u5b89\u5168\u6216\u5728\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\u4e2d\u6ce8\u660e\u5904\u65b9\u836f\u7684\u836f\u54c1\u3002\u5904\u65b9\u836f\u53c8\u7ec6\u5206\u4e3a\u521b\u65b0\u836f\uff08NDA\uff09\u548c\u4eff\u5236\u836f\uff08Generics\uff09\u3002\u521b\u65b0\u836f\u662f\u6307\u9996\u6b21\u4e0a\u5e02\u7684\u54c1\u724c\u836f\uff0c\u4e00\u822c\u5728\u4e0a\u5e02\u7684\u524d\u51e0\u5e74\u6709\u4e13\u5229\u548c\u5e02\u573a\u4e13\u8425\u4fdd\u62a4\u3002\u4eff\u5236\u836f\u662f\u6307\u65b0\u836f\u4e13\u5229\u548c\u4e13\u8425\u4fdd\u62a4\u671f\u8fc7\u540e\uff0c\u7531\u5176\u4ed6\u5382\u5546\u5236\u9020\u7684\u3001\u542b\u6709\u540c\u6837\u836f\u7269\u6210\u5206\u5e76\u8bc1\u660e\u5177\u6709\u540c\u7b49\u6cbb\u7597\u6548\u679c\u7684\u836f\u54c1\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u975e\u5904\u65b9\u836f\u5728\u7f8e\u56fd\u88ab\u79f0\u4e3aOTC\uff08Over The Counter\uff09\u836f\u54c1\u3002OTC\u836f\u54c1\u4e0d\u9700\u8981\u533b\u751f\u5904\u65b9\uff0c\u6d88\u8d39\u8005\u53ef\u6839\u636e\u81ea\u5df1\u638c\u63e1\u7684\u533b\u836f\u77e5\u8bc6\uff0c\u6216\u5411\u836f\u5242\u5e08\u54a8\u8be2\uff0c\u6216\u501f\u52a9\u836f\u54c1\u8bf4\u660e\u4e66\uff0c\u6216\u6839\u636e\u5bf9\u81ea\u5df1\u75c5\u60c5\u7684\u5224\u65ad\uff0c\u76f4\u63a5\u5728\u836f\u5e97\u67dc\u53f0\u4e0a\u9009\u8d2d\u7684\u836f\u54c1\u3002OTC\u836f\u54c1\u6709\u4e00\u5957\u4e0e\u5904\u65b9\u836f\u54c1\u5b8c\u5168\u4e0d\u540c\u7684\u6cd5\u89c4\u7ba1\u7406\u7cfb\u7edf&#8211;&#8220;OTC\u4e13\u8bba&#8221;\uff08OTC Monographs\uff09\u3002OTC\u4e13\u8bba\u662f\u4e00\u79cd\u7c7b\u4f3c&#8221;\u98df\u8c31&#8221;\u7684\u8d44\u6599\uff0c\u88ab\u7f16\u5165\u300a\u8054\u90a6\u7ba1\u7406\u6cd5\u300b\u3002\u5217\u5165\u8be5\u4e13\u8bba\u7cfb\u7edf\u7684\u975e\u5904\u65b9\u836f\u4e0a\u5e02\u65e0\u987b\u7ecf\u8fc7\u4e0a\u5e02\u524d\u5ba1\u6279\u3002\u672a\u5217\u5165OTC\u4e13\u8bba\u7684\u836f\u54c1\u4e0a\u5e02\u9014\u5f84\u4e3b\u8981\u6709\uff1a\uff081\uff09\u5411FDA\u9012\u4ea4\u7533\u8bf7\uff0c\u8981\u6c42\u5217\u5165OTC\u4e13\u8bba\uff1b\uff082\uff09\u9996\u5148\u7533\u8bf7\u4f5c\u4e3a\u65b0\u5904\u65b9\u836f\u4e0a\u5e02\uff0c\u9500\u552e\u591a\u5e74\u540e\u518d\u7533\u8bf7\u8f6c\u4e3aOTC\u8d44\u683c\uff1b\uff083\uff09\u6309\u7167\u4eff\u5236\u836f\u7533\u8bf7\u7a0b\u5e8f\u4e0a\u5e02\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u690d\u7269\u836f\uff08Botanicals\uff09\u548c\u751f\u7269\u836f\uff08Biologics\uff09\u5728\u7f8e\u56fd\u7684\u6cd5\u89c4\u4e0a\u6ca1\u6709\u4e13\u7c7b\u7ba1\u7406\uff0c\u8bb8\u591a\u5177\u6709\u60a0\u4e45\u5386\u53f2\u7684\u690d\u7269\u836f\u6210\u5206\u5df2\u5f52\u5165OTC\u4e13\u8bba\u7cfb\u7edf\uff0c\u800c\u65b0\u7684\u690d\u7269\u836f\u5219\u5fc5\u987b\u7ecf\u65b0\u836f\u5ba1\u6279\uff08NDA\uff09\u9014\u5f84\u4e0a\u5e02\uff0c\u76ee\u524d\u4ec5\u6709\u4e24\u5473\u836f\u83b7\u5f97\u6279\u51c6\uff08Veregen\u548cFulyzaq\uff09\u3002\u751f\u7269\u5236\u54c1\u5206\u4e3a\u4e24\u5927\u7c7b\uff0c\u8840\u6d46\u548c\u8840\u5236\u54c1\u4ee5\u53ca\u75ab\u82d7\u7c7b\u7b49\u4e0d\u7528\u4e8e&#8221;\u6cbb\u7597&#8221;\u75be\u75c5\u7684\u4ea7\u54c1\u5f52FDA&#8221;\u751f\u7269\u5236\u54c1\u8bc4\u5ba1\u4e0e\u7814\u7a76\u4e2d\u5fc3&#8221;\uff08CBER\uff09\u7ba1\u7406\uff1b\u53e6\u4e00\u7c7b\u7528\u4e8e\u6cbb\u7597\u76ee\u7684\u7684\u751f\u7269\u836f\u5c5e\u4e8e\u8fd1\u6765\u53d1\u5c55\u8d77\u6765\u7684\u65b0\u6280\u672f\u9886\u57df\uff0c\u5168\u90e8\u6309\u7167\u65b0\u5904\u65b9\u836f\u7531FDA\u7684&#8221;\u533b\u836f\u5ba1\u8bc4\u4e0e\u7814\u7a76\u4e2d\u5fc3&#8221;\uff08CDER\uff09\u7ba1\u7406\u3002\u56e0\u4e3a\u751f\u7269\u6280\u672f\u4ea7\u54c1\u7684\u590d\u6742\u6027\uff0c\u5176&#8221;\u4eff\u5236&#8221;\u54c1\u5f88\u96be\u8bc1\u660e\u4e0e\u4ea7\u54c1\u5b8c\u5168\u4e00\u81f4\uff0c\u56e0\u6b64\u751f\u7269\u836f\u7684&#8221;\u4eff\u5236&#8221;\u54c1\u4e0d\u79f0\u4e3a&#8221;Generics&#8221;\uff0c\u800c\u4e00\u822c\u79f0\u4e3a&#8221;\u751f\u7269\u76f8\u4f3c\u836f&#8221;\uff08Biosimilars\uff09\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7f8e\u56fd FDA \u751f\u7269\u76f8\u4f3c\u836f\u76f8\u5173\u653f\u7b56\u6cd5\u89c4\uff1a<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000351\uff08K\uff09\uff1a\u300a\u7f8e\u56fd\u533b\u6539\u6cd5\u6848\u300b\u4e2d\u65b0\u589e\u7684\u300a\u516c\u5171\u5065\u5eb7\u670d\u52a1\u6cd5\u300b\uff08Public Health Service Act, PHS Act\uff09\u7b2c351\uff08k\uff09\u6761\u6b3e\u89c4\u5b9a\u4e86\u751f\u7269\u76f8\u4f3c\u7269\u836f\u54c1\u7684\u7b80\u5316\u7a0b\u5e8f\u5ba1\u6279\u8981\u6c42\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000505\uff08b\uff09\uff1a\u5728\u7f8e\u56fd\u5df2\u4e0a\u5e02\u7684\u751f\u7269\u4eff\u5236\u836f\u5982\u4eba\u751f\u957f\u6fc0\u7d20\u3001\u80f0\u5c9b\u7d20\u7b49\uff0c\u5927\u591a\u662f\u6839\u636e\u300a\u8054\u90a6\u98df\u54c1\u836f\u7269\u53ca\u5316\u5986\u54c1\u7ba1\u7406\u6cd5\u300b(Federal Food Drug and Cosmetic Act,FD&amp;C Act)\u4e2d505(b)(2)\u9014\u5f84\u6279\u51c6\u7684\u3002\u57282020\u5e743\u670823\u65e5\u524d\uff0c\u6309\u7167505\uff08b\uff09\u6279\u51c6\u7684\u751f\u7269\u4eff\u5236\u836f\u53ef\u88ab\u8ba4\u4e3a\u83b7\u5f97\u4e86\u5728351\uff08k\uff09\u7684\u6307\u5bfc\u4e0b\u83b7\u5f97\u7684\u751f\u7269\u8bb8\u53ef\u8bc1\u7533\u8bf7\uff08BLA\uff09\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u30002009-\u300a\u751f\u7269\u836f\u4ef7\u683c\u7ade\u4e89\u53ca\u521b\u65b0\u6cd5\u300b\uff08The Biologics PriceCompetition and Innovation Act\uff0cBPCI Act\uff09\uff1a\u8ba2\u7acb\u4e86\u751f\u7269\u76f8\u4f3c\u7269\u836f\u54c1\u4e0a\u5e02\u7684\u7b80\u5316\u7a0b\u5e8f\uff0c\u5e0c\u671b\u901a\u8fc7\u7ade\u4e89\u6765\u964d\u4f4e\u836f\u4ef7\uff0c\u8fbe\u5230\u533b\u6539\u76ee\u7684\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000&#8221;\u751f\u7269\u4eff\u5236\u836f\u9014\u5f84&#8221;\uff08BiosimilarsPathway)-\u533b\u7597\u6539\u9769\u6cd5\u6848\uff08Patient Protection and Affordable CareAct\uff09\uff1a2010\u5e743\u6708\uff0c\u7f8e\u56fd\u5965\u5df4\u9a6c\u603b\u7edf\u7b7e\u7f72\u4e86\u533b\u7597\u6539\u9769\u6cd5\u6848\uff08Patient Protection and Affordable Care Act\uff09\u3002\u6b64\u6cd5\u6848\u4e2d\u4e00\u4e9b\u6761\u6b3e\u5236\u5b9a\u4e86\u751f\u7269\u4eff\u5236\u836f\u8fdb\u5165\u5e02\u573a\u7684\u7b80\u5316\u7533\u8bf7\u9014\u5f84\uff0c\u53c8\u79f0&#8221;\u751f\u7269\u4eff\u5236\u836f\u9014\u5f84&#8221;\uff08BiosimilarsPathway)\uff0c\u8fd9\u65e0\u7591\u7ed9\u751f\u7269\u4eff\u5236\u836f\u63d0\u4f9b\u4e86\u65b0\u7684\u673a\u9047\u30022012 \u5e74 6 \u6708\u7f8e\u56fd\u6700\u9ad8\u6cd5\u9662\u51b3\u5b9a\uff0c\u62e5\u62a4\u300a2010 \u60a3\u8005\u4fdd\u62a4\u4e0e\u5e73\u4ef7\u533b\u7597\u6cd5\u6848 (PPACA)\u300b\u3002\u9996\u5148\uff0c\u8be5\u6cd5\u6848\u5b9a\u4e49&#8221;\u751f\u7269\u4eff\u5236&#8221;\u4ea7\u54c1\u4e3a\u4e0e\u53c2\u7167\u4ea7\u54c1\uff08\u5982\u65b0\u836f\uff09&#8221;\u9ad8\u5ea6\u76f8\u4f3c&#8221;\u7684\u751f\u7269\u5236\u54c1\u3002&#8221;\uff08\u751f\u7269\u4eff\u5236\u4ea7\u54c1\u548c\u53c2\u7167\u4ea7\u54c1\uff09\u5373\u4f7f\u5728\u4e34\u5e8a\u4e0a\u975e\u6d3b\u6027\u7684\u7ec4\u5206\u53ef\u80fd\u6709\u5fae\u5c0f\u5dee\u522b&#8221;\uff0c\u4f46&#8221;\u5b89\u5168\u6027\u3001\u4ea7\u54c1\u7684\u7eaf\u5ea6\u548c\u6548\u529b\u5728\u4e34\u5e8a\u4e0a\u5e76\u65e0\u6709\u610f\u4e49\u7684\u5dee\u5f02&#8221;\u3002\u6839\u636e\u6b64\u6cd5\u6848\uff0c\u751f\u7269\u4eff\u5236\u836f\u7684\u7533\u8bf7\u4eba\u5728\u65b0\u836f\u83b7\u51c6\u9500\u552e\u76844\u5e74\u5185\u4e0d\u5f97\u5411\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08USFDA)\u63d0\u4ea4\u751f\u7269\u4eff\u5236\u836f\u7b80\u5316\u7533\u8bf7\uff0c\u800cUSFDA\u4e0d\u53ef\u5728\u521b\u65b0\u836f\u54c1\u83b7\u51c6\u9500\u552e\u768412\u5e74\u5185\u6279\u51c6\u751f\u7269\u4eff\u5236\u836f\u7b80\u5316\u7533\u8bf7\uff0c\u4ece\u800c\u4fdd\u8bc1\u65b0\u836f\u7684\u5e02\u573a\u72ec\u5360\u671f\u6700\u5c11\u4e3a12\u5e74\u3002\u5176\u6b21\uff0c\u751f\u7269\u4eff\u5236\u836f\u9014\u5f84\u5236\u5b9a\u4e86\u4e00\u4e2a\u65b0\u836f\u751f\u4ea7\u5546\u4e0e\u4eff\u5236\u836f\u7533\u8bf7\u4eba\u4e4b\u95f4\u76f8\u4e92\u4ea4\u6362\u6709\u5173\u4e13\u5229\u4fe1\u606f\u7684\u673a\u5236\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">1.3.1.2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7ba1\u5236\u836f\u54c1<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5904\u65b9\u836f\u4e0d\u4f46\u5fc5\u987b\u6309\u7167\u300a\u98df\u54c1\u3001\u836f\u54c1\u548c\u5316\u5986\u54c1\u6cd5\u300b\uff08FDCA\uff09\u6761\u6b3e\uff0c\u9075\u4eceFDA\u7684\u836f\u54c1\u6cd5\u89c4\u7ba1\u7406\u89c4\u5b9a\uff0c\u8fd8\u5fc5\u987b\u9075\u4ece\u300a\u7f8e\u56fd\u6cd5\u5178\u300b\uff08USC\uff09\u4e2d\u7684&#8221;\u7ba1\u5236\u7269\u8d28\u6cd5&#8221;\uff08Controlled Substances Act,CSA\uff09\u6761\u4f8b\u3002\u8be5\u6761\u4f8b\u5bf9\u90a3\u4e9b\u5177\u6709\u6f5c\u5728\u6ee5\u7528\u6027\u8d28\u836f\u54c1\u5982\u9ebb\u9189\u5242\u3001\u5174\u594b\u5242\u3001\u9547\u9759\u5242\u3001\u8ff7\u5e7b\u5242\u3001\u5408\u6210\u4ee3\u8c22\u7684\u7c7b\u56fa\u9187\u4ee5\u53ca\u7528\u4e8e\u88ab\u7ba1\u5236\u7c7b\u7684\u5316\u5b66\u7269\u8d28\u7b49\u8fdb\u884c\u4e25\u683c\u7684\u63a7\u5236\uff0c\u5e76\u6839\u636e\u533b\u7597\u4ef7\u503c\u3001\u6709\u5bb3\u7a0b\u5ea6\u3001\u6ee5\u7528\u6216\u4e0a\u763e\u7684\u6f5c\u5728\u7a0b\u5ea6\u5c06\u8fd9\u4e9b\u88ab\u7ba1\u5236\u7269\u8d28\u5212\u5206\u4e3a\u4e94\u7c7b\u3002\u7f8e\u56fd&#8221;\u836f\u7269\u5f3a\u5236\u7ba1\u7406\u5c40&#8221;\uff08DrugEnforcement Administration,DEA\uff09\u5728\u5b9a\u8bba\u67d0\u836f\u54c1\u4e3a\u53d7\u7ba1\u5236\u7c7b\u65f6\u6709\u8d23\u4efb\u5411FDA\u54a8\u8be2\uff0cDEA\u5bf9\u4e00\u3001\u4e8c\u7ea7\u7ba1\u5236\u836f\u54c1\u8fd8\u8bbe\u5b9a\u5e74\u751f\u4ea7\u5b9a\u989d\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">1.3.1.3<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u51cf\u514d\u4e0a\u5e02\u7533\u8bf7\u7684\u836f\u54c1<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u9664\u4e0a\u8ff0\u836f\u54c1\u5916\uff0c\u6709\u4e09\u7c7b\u533b\u7597\u4ea7\u54c1\u5728\u7f8e\u56fd\u53ef\u76f4\u63a5\u9500\u552e\uff0c\u65e0\u987bFDA\u4e0a\u5e02\u5ba1\u6279\uff1a\u4e00\u662f\u987a\u52bf\u7597\u6cd5\u4ea7\u54c1\uff08Homeopathic\uff09\uff0c\u4e8c\u662f\u836f\u623f\u590d\u5408\u836f\u54c1\uff08Pharmacy Compounding\uff09\uff1b\u4e09\u662f\u5c5e\u4e8e\u5c65\u884c\u836f\u6548\u7814\u7a76\uff08DESI\uff09\u7c7b\u836f\u54c1\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u987a\u52bf\u7597\u6cd5\u662f\u5fb7\u56fd\u533b\u5e08Samuel Hahnemann\u57281976\u5e74\u521b\u7acb\u7684\u4e00\u79cd\u533b\u7597\u7cfb\u7edf\uff0c\u5728\u539f\u5219\u4e0a\u4ee5\u540c\u7c7b\u76f8\u6cbb\u4e3a\u7406\u8bba\u539f\u5219\uff0c\u57fa\u672c\u4e0a\u662f\u7528\u6781\u5ea6\u7a00\u91ca\u7684\u836f\u7269\u8fdb\u884c\u6cbb\u7597\u3002\u8be5\u7597\u6cd5\u4f34\u968f\u7740\u7f8e\u56fd70\u5e74\u4ee3\u5174\u8d77\u7684\u6574\u4f53\u8bba\u548c\u81ea\u7136\u7597\u6cd5\u800c\u590d\u82cf\u63a8\u5e7f\uff0c\u8be5\u7c7b\u4ea7\u54c1\u7684\u751f\u4ea7\u4e0d\u53d7GMP\u4e2d\u4ea7\u54c1\u6709\u6548\u671f\u3001\u6210\u54c1\u6027\u8d28\u3001\u8ba1\u91cf\u7684\u68c0\u9a8c\u7b49\u5236\u7ea6\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u836f\u623f\u590d\u5408\u836f\u54c1\u662f\u7531\u533b\u7597\u673a\u6784\uff08\u836f\u623f\uff09\u914d\u5236\u7684\u5236\u5242\uff0c\u836f\u623f\u4ec5\u5728\u83b7\u5f97\u533b\u5e08\u5904\u65b9\u7684\u60c5\u51b5\u4e0b\u624d\u53ef\u4ee5\u8fdb\u884c\u836f\u54c1\u914d\u5236\uff0c\u4f46\u4e5f\u63a5\u53d7FDA\u7684\u4e25\u683c\u76d1\u7ba1\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5c65\u884c\u836f\u6548\u7814\u7a76\u7c7b\u836f\u54c1\u662f\u57281938\u5e74\u4ee5\u524d\u4e0a\u5e02\u548c\u5386\u53f2\u4e0a\u4ec5\u6839\u636e\u5b89\u5168\u6027\u7814\u7a76\u4e0a\u5e02\u7684\u836f\u54c1\uff0c\u8fd9\u4e9b\u836f\u5c5e\u4e8e\u4e0d\u65ad\u8fdb\u884c\u4e2d\u7684\u300a\u836f\u6548\u7814\u7a76\u5b9e\u65bd\u65b9\u6848\u300b\uff08DESI\uff09\u9879\u76ee\uff0c\u4e0d\u5c5e\u4e8e\u4e0a\u5e02\u524d\u5ba1\u6279\u7684\u836f\u54c1\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">1.3.2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u836f\u54c1\u7684\u4e13\u5229\u4fdd\u62a4\u548c\u4e13\u8425\u4fdd\u62a4\u671f<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">1.3.2.1<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e13\u5229\u4fdd\u62a4<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u836f\u54c1\u4e13\u5229\u4fdd\u62a4\u662f\u6307\u4e13\u5229\u6301\u6709\u8005\u7ecf\u4e13\u5229\u6ce8\u518c\u540e\uff0c\u7531\u7f8e\u56fd\u4e13\u5229\u5546\u6807\u5c40\uff08PTO\uff09\u4fdd\u62a4\u53d1\u660e\u8005\u521b\u9020\u7684\u836f\u54c1\u5728\u4e00\u5b9a\u671f\u9650\u5185\u4e0d\u88ab\u4ed6\u4eba\u5236\u9020\u3001\u4f7f\u7528\u548c\u9500\u552e\u3002\u4e13\u5229\u7533\u8bf7\u5728\u836f\u54c1\u7814\u53d1\u6216\u4e0a\u5e02\u540e\u90fd\u53ef\u4ee5\u7533\u8bf7\u30021995\u5e746\u67088\u65e5\u751f\u6548\u7684\u300a\u4e4c\u62c9\u572d\u56de\u5408\u534f\u8bae\u6cd5\u300b\u4f7f\u7f8e\u56fd\u4e13\u5229\u6cd5\u89c4\u89c4\u5b9a\u7684\u4e13\u5229\u6709\u6548\u671f\u5982\u4e0b\uff1a<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u30001\u30011995\u5e746\u67088\u65e5\u524d\u6ce8\u518c\u7684\u4e13\u5229\u6709\u6548\u671f\u4e3a17\u5e74\uff0c\u4ece\u4e13\u5229\u83b7\u51c6\u65e5\u7b97\u8d77\uff1b<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u30002\u30011995\u5e746\u67088\u65e5\u540e\u6ce8\u518c\u7684\u4e13\u5229\u6709\u6548\u671f\u4e3a20\u5e74\uff0c\u4ece\u4e13\u5229\u7533\u62a5\u65e5\u7b97\u8d77\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5bf9\u672a\u8fc7\u671f\u7684\u3001\u57281995\u5e746\u67088\u65e5\u524d\u6ce8\u518c\u7684\u4e13\u5229\uff0c\u6309\u65e7\u6cd5\u6216\u65b0\u6cd5\u89c4\u5b9a\u4e2d\u4e13\u5229\u671f\u8f83\u957f\u7684\u7b97\u6cd5\u751f\u6548\u3002\u4e3a\u9f13\u52b1\u65b0\u53d1\uff0c\u8865\u507f\u4e13\u5229\u6301\u6709\u8005\u5728\u836f\u54c1\u7814\u53d1\u548c\u5ba1\u6279\u7684\u6f2b\u957f\u8fc7\u7a0b\u4e2d\u4fdd\u62a4\u65f6\u95f4\u7684\u635f\u5931\uff0c\u7f8e\u56fd1984\u5e74\u901a\u8fc7\u7684\u300a\u836f\u54c1\u4ef7\u683c\u7ade\u4e89\u548c\u4e13\u5229\u671f\u6062\u590d\u6cd5\u300b\u5141\u8bb8\u4eba\u7528\u836f\u54c1\u4e13\u5229\u53ef\u83b7\u5f975\u5e74\u7684\u4e13\u5229\u671f\u5ef6\u957f\uff0c\u4f46\u836f\u54c1\u6279\u51c6\u540e\u52a0\u4e0a\u5ef6\u957f\u7684\u4e13\u5229\u671f\u4e0d\u5f97\u8d85\u8fc714\u5e74\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">1.3.2.2<span class=\"Apple-converted-space\">&nbsp;<\/span><\/span><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5e02\u573a\u4e13\u8425\u4fdd\u62a4\u671f<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5e02\u573a\u4e13\u8425\u4fdd\u62a4\u671f\u662f\u5728\u65b0\u836f\u6279\u51c6\u65f6FDA\u4f9d\u6cd5\u6388\u4e88\u836f\u54c1\u7533\u62a5\u8005\u7684\u5e02\u573a\u4e13\u8425\u4fdd\u62a4\u671f\u3002\u5176\u5c5e\u4e8e\u884c\u653f\u4fdd\u62a4\uff0c\u4e0e\u8be5\u836f\u54c1\u6709\u65e0\u4e13\u5229\u65e0\u5173\uff0c\u76ee\u7684\u5728\u4e8e\u8865\u507f\u836f\u54c1\u5728\u7814\u53d1\u548c\u5ba1\u6279\u8fc7\u7a0b\u4e2d\u5931\u53bb\u7684\u4e13\u5229\u4fdd\u62a4\u65f6\u95f4\u3002\u4e00\u822c\u6765\u8bf4\uff0c\u4e13\u8425\u4fdd\u62a4\u671f\u6709\u4ee5\u4e0b\u51e0\u79cd\uff1a<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u30001\u3001\u65b0\u5316\u5b66\u5b9e\u4f53\uff08NCE\uff095\u5e74\u4fdd\u62a4\u671f\uff1b<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u30002\u3001\u5916\u52a0\u7684\u4e34\u5e8a\u7814\u7a763\u5e74\u4fdd\u62a4\u671f\uff1b<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u30003\u3001\u7f55\u89c1\u75c5\u836f\u54c17\u5e74\u4fdd\u62a4\u671f\uff1b<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word 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style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u7ecfFDA\u5ba1\u6279\u7684\u836f\u54c1\u5168\u90e8\u6536\u5165FDA\u6ce8\u518c\u836f\u54c1\u5927\u5168\u300a\u7ecf\u8fc7\u6cbb\u7597\u7b49\u540c\u6027\u8bc4\u4ef7\u6279\u51c6\u7684\u836f\u54c1\u300b\u5373&#8221;\u6a59\u76ae\u4e66&#8221;\uff0c\u5176\u4e2d\u660e\u786e\u5217\u51fa\u4e86\u65b0\u836f\u6240\u6d89\u53ca\u7684\u6240\u6709\u4e13\u5229\u548c\u5e02\u573a\u4e13\u8425\u4fdd\u62a4\u671f\u4fe1\u606f\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(59, 89, 152);line-height: 19.5px;font-family: 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style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;text-align: left;line-height: 25.5px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word 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black;line-height: 19.5px;font-family: \u5b8b\u4f53;font-size: 13px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000\u3000\u5bf9\u4e8e\u539f\u6599\u836f\uff08API\uff09\u751f\u4ea7\u5546\u3002\u4e00\u65e6\u751f\u4ea7\u8bbe\u65bd\u88ab\u68c0\u67e5\u5e76\u786e\u8ba4GMP\u6807\u51c6\u8fc7\u5173\uff0c\u4fbf\u53ef\u4ee5\u8fdb\u884c\u8bbe\u65bd\u6ce8\u518c\u548c\u767b\u8bb0\u3002FDA\u4e0d\u5c06\u539f\u6599\u836f\u4f5c\u4e3a&#8221;\u6279\u51c6\u4e0e\u5426&#8221;\u4e4b\u5217\uff0c\u4f46\u5404\u5236\u5242\u5fc5\u987b\u4f7f\u7528\u8be5\u836f\u54c1\u5ba1\u6279\u8fc7\u7684\u5236\u9020\u573a\u5730\u6765\u6e90\u3002<\/span><\/p>\n<section><mpcps frameborder=\"0\" class=\"js_editor_cps\"  style=\"width:100% !important;border:0;\"           ><\/mpcps><\/section>\n<p><br  \/><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>1.1&nbsp;\u7f8e\u56fd\u6982\u51b5 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[&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":81681,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/81680"}],"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=81680"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/81680\/revisions"}],"predecessor-version":[{"id":81682,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/81680\/revisions\/81682"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/81681"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=81680"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=81680"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=81680"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}