{"id":24819,"date":"2021-12-25T10:05:50","date_gmt":"2021-12-25T02:05:50","guid":{"rendered":"https:\/\/www.paiqinano.com\/?p=24819"},"modified":"2021-12-25T09:00:40","modified_gmt":"2021-12-25T01:00:40","slug":"fda%e8%ae%a4%e8%af%81","status":"publish","type":"post","link":"https:\/\/www.paiqinano.com\/?p=24819","title":{"rendered":"FDA\u8ba4\u8bc1"},"content":{"rendered":"<p style=\"line-height: 3em;\">FDA\u662f\u98df\u54c1\u7c7b\u836f\u76d1\u5c40\uff08Food and Drug Administration\uff09\u7684\u901a\u79f0\u3002FDA\u6709\u65f6\u5019\u4e5f\u610f\u5473\u7740\u82f1\u56fd\u98df\u54c1\u7c7b\u836f\u76d1\u5c40\u3002FDA\u7531\u7f8e\u56fd\u4f17\u8bae\u9662\u5373\u7f8e\u56fd\u8054\u90a6\u653f\u5e9c\u53d7\u6743\uff0c\u662f\u4e13\u4e1a\u98df\u54c1\u7c7b\u4e0e\u836f\u54c1\u76d1\u7ba1\u7684\u6700\u5927\u884c\u653f\u673a\u5173\uff0c\u4e5f\u662f\u4e00\u4e2a\u7531\u533b\u5e08\u3001\u5211\u4e8b\u8fa9\u62a4\u5f8b\u5e08\u3001\u5fae\u751f\u7269\u5b66\u5bb6\u3001\u79d1\u5b66\u5bb6\u548c\u9057\u4f20\u5b66\u5bb6\u7b49\u4e13\u4e1a\u4eba\u5458\u6784\u6210\u7684\u4e13\u6ce8\u4e8e\u7ef4\u62a4\u3001\u63a8\u52a8\u548c\u63d0\u5347\u56fd\u6c11\u5065\u5eb7\u7684\u653f\u5e9c\u90e8\u95e8\u73af\u5883\u536b\u751f\u7ba1\u63a7\u7684\u76d1\u7ba1\u7ec4\u7ec7\u3002\u5176\u4ed6\u4e00\u4e9b\u56fd\u5bb6\u90fd\u6839\u636e\u5bfb\u627e\u548c\u63a5\u53d7 FDA \u7684\u534f\u52a9\u6765\u63a8\u52a8\u5e76\u76d1\u7ba1\u5176\u8be5\u56fd\u5546\u54c1\u7684\u5b89\u5168\u6027\u3002<\/p>\n<ul style=\"margin: 0px; padding: 0px; width: 395px; float: left;\">\n<li>\n<p style=\"text-align: left; line-height: 3em;\">\u4e2d\u6587\u540d\u5b57<\/p>\n<\/li>\n<li>\n<p style=\"text-align: left; line-height: 3em;\">\u98df\u54c1\u7c7b\u836f\u76d1\u5c40<\/p>\n<\/li>\n<li>\n<p style=\"text-align: left; line-height: 3em;\">\u82f1\u8bed\u540d<\/p>\n<\/li>\n<li>\n<p style=\"text-align: left; line-height: 3em;\">FDA<\/p>\n<\/li>\n<\/ul>\n<ul style=\"margin: 0px; padding: 0px; width: 395px; float: left;\">\n<li>\n<p style=\"text-align: left; line-height: 3em;\">\u53d7\u6743\u56fd<\/p>\n<\/li>\n<li>\n<p style=\"text-align: left; line-height: 3em;\">\u82f1\u56fd<\/p>\n<\/li>\n<li>\n<p style=\"text-align: left; line-height: 3em;\">\u521b\u7acb\u6642\u95f4<\/p>\n<\/li>\n<li>\n<p style=\"text-align: left; line-height: 3em;\">1906\u5e74<\/p>\n<\/li>\n<\/ul>\n<ol style=\"list-style-type: none;\">\n<li><\/li>\n<li>\n<p style=\"line-height: 3em;\">\n<\/li>\n<\/ol>\n<h2 style=\"margin: 0px; padding: 0px 8px 0px 18px; font-size: 22px; float: left; font-weight: 400; background-image: initial; background-position: initial; background-size: initial; background-attachment: initial; line-height: 3em;\">\u7ec4\u7ec7\u8be6\u7ec6\u4ecb\u7ecd<\/h2>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p style=\"line-height: 3em;\">\u82f1\u56fdFDA \u662f\u7f8e\u653f\u5e9c\u5728\u8eab\u5fc3\u5065\u5eb7\u4e0e\u4eba\u4eec\u670d\u52a1\u4e2d\u5fc3 (DHHS) \u5c5e\u4e0b\u7684\u516c\u5171\u6027\u56fd\u5bb6\u536b\u751f\u90e8(PHS) \u4e2d\u5f00\u8bbe\u7684\u6267\u884c\u5668\u4e4b\u4e00\u3002FDA\u5173\u952e\u5206\u68c0\u6d4b\u548c\u7533\u8bf7\u6ce8\u518c2\u4e2a\u5167\u5bb9\uff0c\u533b\u7597\u8bbe\u5907\u62a4\u80a4\u54c1\u98df\u54c1\u836f\u54c1\u5b89\u5168\u4ea7\u54c1\u5fc5\u987b\u5f00\u5c55FDA\u7533\u8bf7\u6ce8\u518c\uff0cFDA\u7533\u8bf7\u6ce8\u518c\u53ef\u4ee5\u7acb\u5373\u5728FDA\u5b98\u7f51\u4e0a\u5f00\u5c55\u7533\u8bf7\u529e\u7406\u3002<\/p>\n<p style=\"line-height: 3em;\">FDA\u521b\u7acb\u4e8e1906\u5e74\uff1b\u4ee5\u524d\u82f1\u56fd\u7684\u836f\u7269\u6ca1\u6709\u7ba1\u63a7\uff0c\u836f\u7269\u6839\u636e\u5e7f\u544a\u5ba3\u4f20\u5b9e\u73b0\u5e02\u573a\u9500\u552e\uff1b1938\u5e74\u89c4\u5b9a\u5bf9\u836f\u7269\u8bc1\u5b9e\u5b89\u5168\u7cfb\u6570\u540e\uff0c\u624d\u53ef\u4ee5\u5e02\u573a\u9500\u552e\uff1b1962\u5e74\uff0c\u89c4\u5b9a\u836f\u7269\u4e0d\u4f46\u6709\u5b89\u5168\u7cfb\u6570\u8fd8\u9700\u8981\u8bc1\u5b9e\u5408\u7406\u624d\u53ef\u5e02\u573a\u9500\u552e\u3002<\/p>\n<p style=\"line-height: 3em;\">\u98df\u54c1\u7c7b\u836f\u76d1\u5c40\uff08FDA\uff09\u8d1f\u8d23\u4eba\uff1a\u98df\u54c1\u7c7b\u3001\u836f\u7269\uff08\u5305\u542b\u9972\u6599\uff09\u3001\u533b\u7597\u8bbe\u5907\u3001\u98df\u7528\u6dfb\u52a0\u5242\u3001\u62a4\u80a4\u54c1\u3001\u5c0f\u52a8\u7269\u98df\u54c1\u7c7b\u53ca\u836f\u7269\u3001\u9152\u7cbe\u6d53\u5ea6\u5c0f\u4e8e7%\u7684\u7ea2\u9152\u996e\u54c1\u53ca\u5176\u7535\u5b50\u8bbe\u5907\u7684\u76d1\u7ba1\u68c0\u6d4b\uff1b\u5546\u54c1\u5728\u5e94\u7528\u6216\u4ea4\u6613\u5168\u8fc7\u7a0b\u4e2d\u5f62\u6210\u7684\u6b63\u79bb\u5b50\u3001\u975e\u6b63\u79bb\u5b50\u8f90\u5c04\u6e90\u5371\u5bb3\u4eba\u4eec\u8eab\u5fc3\u5065\u5eb7\u548c\u5b89\u5168\u6027\u65b0\u9879\u76ee\u7684\u68c0\u6d4b\u3001\u68c0\u6d4b\u548c\u62ff\u8bc1\u3002\u4f9d\u636e\u8981\u6c42\uff0c\u4ee5\u4e0a\u5546\u54c1\u52a1\u5fc5\u901a\u8fc7FDA\u68c0\u6d4b\u8bc1\u5b9e\u5b89\u5168\u6027\u540e\uff0c\u5373\u53ef\u5728\u5e02\u5834\u4e0a\u5e02\u573a\u9500\u552e\u3002FDA\u6709\u6743\u5229\u5bf9\u751f\u4ea7\u5546\u5f00\u5c55\u89c6\u67e5\u3001\u6709\u6743\u5229\u5bf9\u8fdd\u6cd5\u8005\u660e\u786e\u63d0\u51fa\u63d0\u8d77\u8bc9\u8bbc\u3002<\/p>\n<p style=\"line-height: 3em;\">\u98df\u54c1\u536b\u751f\u5b89\u5168\u548c\u597d\u7528\u8425\u517b\u6210\u5206\u6838\u5fc3(CFSAN)<\/p>\n<p style=\"line-height: 3em;\">\u8be5\u6838\u5fc3\u662fFDA\u52b3\u52a8\u91cf\u8f83\u5927\u7684\u5355\u4f4d\u3002\u5b83\u627f\u62c5\u9664\u5f00\u8054\u5408\u56fd\u7cae\u519c\u7ec4\u7ec7\u6240\u7ba1\u7684\u8089\u7c7b\u98df\u54c1\u3001\u5bb6\u79bd\u53ca\u86cb\u7c7b\u98df\u54c1\u4e4b\u5916\u7684\u5168\u82f1\u56fd\u7684\u98df\u54c1\u536b\u751f\u5b89\u5168\u3002\u98df\u54c1\u536b\u751f\u5b89\u5168\u548c\u8425\u517b\u6210\u5206\u6838\u5fc3\u4e13\u6ce8\u4e8e\u964d\u4f4e\u98df\u6e90\u6027\u75be\u75c5\uff0c\u63a8\u52a8\u98df\u54c1\u536b\u751f\u5b89\u5168\u3002\u5e76\u63a8\u52a8\u5404\u79cd\u5404\u6837\u65b9\u6848\uff0c\u5982\uff1aHACCP\u65b9\u6848\u7684\u5ba3\u4f20\u6267\u884c\u7b49\u3002<\/p>\n<p style=\"line-height: 3em;\">\u8be5\u57fa\u5730\u7684\u804c\u8d23\u5305\u542b\uff1a\u4fdd\u8bc1\u5728\u98df\u7269\u4e2d\u589e\u52a0\u7684\u7269\u8d28\u53ca\u9ed1\u8272\u7d20\u7684\u5b89\u5168\u6027\uff1b\u4fdd\u8bc1\u6839\u636e\u751f\u7269\u4f53\u52a0\u5de5\u5de5\u827a\u5f00\u53d1\u8bbe\u8ba1\u7684\u98df\u7269\u548c\u8c03\u6599\u7684\u5b89\u5168\u6027\uff1b\u627f\u62c5\u5728\u6070\u5f53\u6807\u5fd7\u98df\u54c1\u7c7b\uff08\u5982\u6210\u4efd\u3001\u5065\u5eb7\u8425\u517b\u7533\u660e\uff09\u548c\u62a4\u80a4\u54c1\u5c42\u9762\u7684\u76d1\u7ba1\u4e3b\u9898\u6d3b\u52a8\uff1b\u5236\u8ba2\u76f8\u5bf9\u5e94\u7684\u73b0\u884c\u653f\u7b56\u548c\u653f\u7b56\u6cd5\u89c4\uff0c\u4ee5\u7ba1\u7406\u65b9\u6cd5\u81b3\u98df\u8865\u5145\u5242\u3001\u5b9d\u5b9d\u98df\u6750\u79d8\u65b9\u548c\u8bca\u7597\u98df\u54c1\u7c7b\uff1b\u4fdd\u8bc1\u62a4\u80a4\u54c1\u6210\u5206\u53ca\u5546\u54c1\u7684\u5b89\u5168\u6027\uff0c\u4fdd\u8bc1\u6070\u5f53\u6807\u5fd7\uff1b\u76d1\u7ba1\u548c\u6807\u51c6\u98df\u54c1\u4f01\u4e1a\u7684\u552e\u540e\u670d\u52a1\u4e2a\u4eba\u884c\u4e3a\uff1b\u5f00\u5c55\u987e\u5ba2\u6587\u5316\u6559\u80b2\u548c\u4e2a\u4eba\u884c\u4e3a\u6269\u5c55\uff1b\u4e0e\u5dde\u548c\u5f53\u5730\u653f\u5e9c\u7684\u9879\u76ee\u5408\u4f5c\uff1b\u878d\u6d3d\u56fd\u9645\u6027\u98df\u54c1\u6807\u51c6\u548c\u5b89\u5168\u6027\u7b49\u3002<\/p>\n<p style=\"line-height: 3em;\">\u836f\u7269\u8bc4\u5b9a\u548c\u7814\u7a76\u6240(CDER)<\/p>\n<p style=\"line-height: 3em;\">\u8be5\u6838\u5fc3\u81f4\u529b\u4e8e\u4fdd\u8bc1\u836f\u54c1\u548c\u975e\u5904\u65b9\u836f\u54c1\u7684\u5b89\u5168\u53ef\u9760\u548c\u5408\u7406\uff0c\u5728\u836f\u7269\u53d1\u552e\u524d\u5bf9\u5b83\u8fdb\u884c\u8bc4\u5b9a\uff0c\u5e76\u76d1\u7ba1\u9500\u552e\u5e02\u573a\u4e0a\u5e02\u573a\u9500\u552e\u7684\u4e00\u4e07\u4f59\u79cd\u836f\u7269\u4ee5\u4fdd\u969c\u5546\u54c1\u8fbe\u5230\u4e0d\u65ad\u521b\u65b0\u7684\u6700\u5927\u89c4\u8303\u3002\u4e0e\u6b64\u540c\u65f6\uff0c\u8be5\u6838\u5fc3\u8fd8\u7ba1\u63a7\u7535\u89c6\u673a\u3001\u5e7f\u64ad\u8282\u76ee\u53ca\u5176\u51fa\u7248\u53d1\u884c\u4e0a\u7684\u836f\u7269\u7684\u5e7f\u544a\u5ba3\u4f20\u7684\u771f\u5b9e\u6709\u6548\u3002\u4e25\u82db\u7ba1\u63a7\u836f\u7269\uff0c\u7ed9\u4e88\u7ed9\u987e\u5ba2\u7cbe\u786e\u5b89\u5168\u6027\u7684\u4fe1\u606f\u5185\u5bb9\u3002<\/p>\n<p style=\"line-height: 3em;\">\u673a\u5668\u8bbe\u5907\u5b89\u5168\u6027\u548c\u5c04\u7ebf\u7ef4\u62a4\u5065\u5eb7\u4e2d\u5fc3(CDRH)<\/p>\n<p style=\"line-height: 3em;\">\u8be5\u6838\u5fc3\u5728\u4fdd\u8bc1\u65b0\u53d1\u552e\u7684\u533b\u7597\u8bbe\u5907\u7684\u5b89\u5168\u53ef\u9760\u548c\u5408\u7406\u3002\u7531\u4e8e\u5728\u4e16\u754c\u5404\u56fd\u6709\u4e09\u4e07\u591a\u5bb6\u516c\u53f8\u751f\u4ea7\u5236\u9020\u4ece\u8840\u7cd6\u76d1\u6d4b\u4eea\u5230\u4eba\u529b\u5fc3\u810f\u74e3\u819c\u7b49\u8d85\u51fa\u516b\u4e07\u79cd\u591a\u79cd\u7c7b\u578b\u7684\u533b\u7597\u8bbe\u5907\u3002\u8fd9\u79cd\u8bbe\u5907\u5168\u662f\u540c\u4eba\u7684\u751f\u547d\u7d27\u5bc6\u76f8\u8fde\u7684\uff0c\u56e0\u6b64\u8be5\u6838\u5fc3\u5e76\u4e14\u8fd8\u7ba1\u63a7\u5168\u56fd\u5404\u5730\u8303\u7574\u5185\u7684\u552e\u540e\u7ef4\u4fee\u670d\u52a1\u7b49\u3002\u9488\u5bf9\u4e00\u4e9b\u8c61\u5fae\u6ce2\u7089\u52a0\u70ed\u3001\u7535\u89c6\u3001\u624b\u673a\u7b49\u80fd\u9020\u6210\u5c04\u7ebf\u7684\u5546\u54c1\uff0c\u8be5\u6838\u5fc3\u4e5f\u660e\u786e\u4e86\u4e00\u4e9b\u5bf9\u5e94\u7684\u68c0\u6d4b\u6807\u51c6\u3002<\/p>\n<p style=\"line-height: 3em;\">\u751f\u7269\u5236\u836f\u8bc4\u5b9a\u548c\u7814\u7a76\u6240(CBER)<\/p>\n<p style=\"line-height: 3em;\">\u8be5\u6838\u5fc3\u7ba1\u63a7\u8fd9\u4e9b\u53ef\u4ee5\u9632\u6b62\u548c\u6cbb\u7597\u75be\u75c5\u7684\u751f\u7269\u5236\u836f\uff0c\u56e0\u800c\u6bd4\u6709\u673a\u5316\u5b66\u7efc\u5408\u578b\u836f\u54c1\u66f4\u4e3a\u7e41\u6742\uff0c\u5b83\u5305\u542b\u5bf9\u8840\u591c\u3001\u8840\u6db2\u3001\u75ab\u82d7\u7b49\u7684\u5b89\u5168\u7cfb\u6570\u548c\u5b9e\u6548\u6027\u5f00\u5c55\u79d1\u7814\u3002<\/p>\n<p style=\"line-height: 3em;\">\u732a\u7528\u836f\u7269\u6838\u5fc3(CVM)<\/p>\n<p style=\"line-height: 3em;\">\u8be5\u6838\u5fc3\u7ba1\u63a7\u5c0f\u52a8\u7269\u7684\u98df\u54c1\u7c7b\u53ca\u836f\u7269\uff0c\u4ee5\u4fdd\u8bc1\u8fd9\u79cd\u5546\u54c1\u5728\u4fdd\u6301\u6027\u547d\uff0c\u7f13\u89e3\u75db\u695a\u7b49\u9886\u57df\u7684\u5e94\u7528\u6027\u3001\u5b89\u5168\u7cfb\u6570\u548c\u5b9e\u6548\u6027\u3002\u82f1\u56fd\u98df\u54c1\u7c7b\u836f\u76d1\u5c40\u64cd\u7eb5\u75af\u725b\u75c5\u7684\u4f5c\u4e1a\u4e5f\u662f\u6839\u636e\u9972\u6599\u6838\u5fc3\u5bf9\u7cbe\u9972\u6599\u751f\u4ea7\u5546\u7684\u67e5\u9a8c\u5f97\u5230\u5b9e\u65bd\u3002 2007\u5e7412\u670819\u65e5\uff0c\u82f1\u56fd\u98df\u54c1\u7c7b\u836f\u76d1\u5c40\u516c\u5e03\u521b\u5efa\u4e00\u4e2a\u7528\u4e8e\u8ffd\u8e2a\u98df\u6750\u7cfb\u7edf\u8f6f\u4ef6\u4e2d\u7684\u514b\u9686\u52a8\u7269\u7684\u6570\u636e\u5e93\u67e5\u8be2\uff0c\u8fdb\u800c\u4f7f\u6709\u5173\u8fa8\u522b\u7a0b\u5e8f\u6d41\u7a0b\u5f97\u5230\u80fd\u591f\u5f00\u5c55\u3002\u8fd9\u4e00\u6570\u636e\u5e93\u67e5\u8be2\u5c06\u53d8\u6210\u5168\u56fd\u5404\u5730\u5c0f\u52a8\u7269\u8bc6\u522b\u6280\u672f(National Animal Identification System)\u7684\u4e00\u90e8\u5206\uff0c\u8be5\u7cfb\u7edf\u8f6f\u4ef6\u7528\u4ee5\u8ffd\u8e2a\u7f8e\u56fd\u5168\u90e8\u4ece\u8fd8\u5728\u519c\u573a\u5582\u517b\u5230\u5df2\u4e0a\u996d\u684c\u7684\u7272\u755c\u3002<\/p>\n<p>&nbsp;<\/p>\n<h2 style=\"margin: 0px; padding: 0px 8px 0px 18px; font-size: 22px; float: left; font-weight: 400; background-image: initial; background-position: initial; background-size: initial; background-attachment: initial; line-height: 3em;\">\u9a8c\u8bc1\u5b9e\u9645\u610f\u4e49<\/h2>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p style=\"line-height: 3em;\">\u82f1\u56fdFDA\u5f52\u5c5e\u4e8e\u7f8e\u56fd\u56fd\u52a1\u9662\u5065\u5eb7\u4fdd\u5065\u4e0e\u670d\u52a1\u4e2d\u5fc3\u7684\u516c\u5171\u5065\u5eb7\u670d\u52a1\u9879\u76ee\u7f72\uff0c\u627f\u62c5\u82f1\u56fd\u5168\u90e8\u76f8\u5173\u98df\u54c1\u7c7b\uff0c\u836f\u7269\uff0c\u62a4\u80a4\u54c1\u53ca\u8f90\u5c04\u5371\u5bb3\u4eea\u5668\u8bbe\u5907\u7684\u7ba1\u7406\u65b9\u6cd5\uff0c\u5b83\u4e5f\u662f\u8377\u5170\u6700\u5f00\u59cb\u7684\u987e\u5ba2\u7ef4\u62a4\u7ec4\u7ec7\u3002FDA\u4e0d\u4f46\u6536\u96c6\u89e3\u51b380\uff0c000\u9879\u82f1\u56fd\u5730\u533a\u751f\u4ea7\u5236\u9020\u6216\u8fdb\u53e3\u7684\u7684\u5546\u54c1\u8bd5\u54c1\u5e76\u65bd\u52a0\u68c0\u6d4b\uff0c\u5e76\u4e14\uff0c\u6bcf\u4e00\u5e74\u5916\u6d3e\u4e0a\u5343\u4f59\u540d\u68c0\u6d4b\u5458\uff0c\u8d76\u8d74\u56fd\u591615,000\u4e2a\u52a0\u5de5\u5382\uff0c\u4ee5\u786e\u5b9a\u5b83\u4eec\u7684\u5404\u79cd\u5404\u6837\u4e3b\u9898\u6d3b\u52a8\u662f\u4e0d\u662f\u5408\u4e4e\u7f8e\u56fd\u7684\u6cd5\u5f8b\u8981\u6c42\u3002<\/p>\n<p style=\"line-height: 3em;\">\u81ea1990\u5e74\u4e4b\u540e\uff0c\u82f1\u56fdFDA\u4e0eISO\u673a\u6784\u7b49\u56fd\u9645\u7ecf\u6d4e\u7ec4\u7ec7\u7d27\u5bc6\u914d\u5408\uff0c\u6301\u7eed\u4fc3\u8fdb\u4e00\u8fde\u4e32\u521b\u65b0\u5bf9\u7b56\u3002\u7279\u522b\u662f\u5728\u5728\u98df\u54c1\u7c7b\u3001\u836f\u7269\u884c\u4e1a\uff0cFDA\u8ba4\u8bc1\u53d8\u6210\u5168\u7403\u98df\u54c1\u7c7b\u3001\u836f\u7269\u7684\u6700\u5927\u6d4b\u8bd5\u6807\u51c6\u3002\u88ab\u4e16\u536b\u7ec4\u7ec7\u8bc4\u5b9a\u4e3a\u6700\u5927\u98df\u54c1\u5b89\u5168\u6807\u51c6\u3002\u4ec5\u6709\u5ba1\u62a5\u7684\u5546\u54c1\u901a\u8fc7\u5bf9\u8eab\u4f53\u5e94\u7528\u5546\u54c1\u540e\u7684143\u4e2a\u91cd\u8981\u68c0\u9a8c\u5b9a\u4f4d\u70b9\u4f5c\u68c0\u6d4b\uff0c\u5bf92-3\u6570\u4e07\u4eba\u4e0d\u65ad3-7\u5e74\u7684\u68c0\u6d4b\uff0c\u5f7b\u5e95\u6839\u636e\u8fbe\u6807\u7684\u5546\u54c1\uff0c\u624d\u4f1a\u7b7e\u53d1FDA\u8ba4\u8bc1\u3002<\/p>\n<p style=\"line-height: 3em;\">\u56e0\u800c\uff0c\u56fd\u9645\u6027\u8bb8\u591a\u751f\u4ea7\u5546\u90fd\u4ee5\u8ffd\u6c42\u5b8c\u7f8e\u5f97\u5230 FDA \u9a8c\u8bc1\u505a\u4e3a\u4ea7\u54c1\u8d28\u91cf\u7684\u6700\u9ad8\u5956\u9879\u548c\u786e\u4fdd\u3002<\/p>\n<p style=\"line-height: 3em;\">FDA\u56fd\u9645\u6027\u968f\u610f\u9500\u552e\u8bb8\u53ef\u8bc1\u4e0d\u4f46\u662f\u82f1\u56fdFDA\u8ba4\u8bc1\u4e2d\u6700\u9ad8\u7ea7\u7684\u9a8c\u8bc1\uff0c\u5e76\u4e14\u662f\u4e16\u754c\u8d38\u6613\u7ec4\u7ec7\uff08WTO\uff09\u6838\u51c6\u76f8\u5173\u98df\u54c1\u7c7b\u3001\u836f\u7269\u7684\u6700\u5927\u884c\u9a76\u9a8c\u8bc1\uff0c\u662f\u52a1\u5fc5\u6839\u636e\u82f1\u56fdFDA\u548c\u4e16\u8d38\u7ec4\u7ec7\u5168\u65b9\u4f4d\u6838\u51c6\u540e\u624d\u53ef\u6d3e\u53d1\u7684\u8d44\u8d28\u8ba4\u8bc1\u3002\u4e00\u65e6\u83b7\u6b64\u9a8c\u8bc1\uff0c\u5546\u54c1\u901a\u7545\u8fdb\u5230\u4e00\u5207WTO\u7ec4\u5458\u6211\u56fd\uff0c\u4e43\u81f3\u8fde\u8425\u9500\u65b9\u5f0f\uff0c\u8be5\u56fd\u653f\u5e9c\u90e8\u95e8\u90fd\u4e0d\u53ef\u5e72\u6d89\u3002<\/p>\n<h2 style=\"margin: 0px; padding: 0px 8px 0px 18px; font-size: 22px; float: left; font-weight: 400; background-image: initial; background-position: initial; background-size: initial; background-attachment: initial; line-height: 3em;\">\u5371\u5bb3<\/h2>\n<p>&nbsp;<\/p>\n<p style=\"line-height: 3em;\">FDA\u5728\u56fd\u5916\u751a\u81f3\u5168\u4e16\u754c\u90fd\u662f\u6709\u6781\u4e3a\u6781\u5927\u7684\u5371\u5bb3\uff0c\u6709\u201c\u5916\u56fd\u4eba\u8eab\u5fc3\u5065\u5eb7\u4fdd\u62a4\u795e\u201d\u4e4b\u79f0\u3002\u5168\u7403\u7684\u836f\u7269\u5546\u548c\u98df\u54c1\u5546\u5bf9\u5176\u53c8\u7231\u53c8\u6015\uff0c\u5b83\u7684\u4fe1\u8a89\u5ea6\u548c\u6280\u672f\u4e13\u4e1a\u6c34\u5e73\u6df1\u5f97\u4f17\u591a\u6743\u5a01\u4e13\u5bb6\u548c\u4f17\u591a\u7fa4\u4f17\u7684\u4fe1\u4efb\uff0c\u800c\u5176\u4e25\u82db\u7684\u68c0\u9a8c\u548c\u8bc4\u5b9a\u5728\u7ed9\u4e88\u4f18\u826f\u786e\u4fdd\u7684\u5e76\u4e14\u4e5f\u9020\u6210\u8bb8\u591a\u836f\u5546\u548c\u98df\u54c1\u5546\u7684\u4e89\u8bae\uff0c\u65a5\u8d23\u5176\u62d8\u675f\u4e86\u521b\u9020\u53d1\u660e\u81ea\u4e3b\u521b\u65b0\uff0c\u662f\u963b\u788d\u7fa4\u4f17\u5f97\u5230\u4e13\u7528\u836f\u7684\u6700\u5927\u7684\u963b\u788d\uff0c\u5e76\u529d\u8c0f\u7f8e\u56fd\u56fd\u4f1a\u51cf\u5c11FDA\u7684\u7ba1\u7406\u6743\u9650\uff0c\u4f46\u8fd9\u4e9b\u4f5c\u6cd5\u5e76\u6ca1\u6709\u5371\u5bb3FDA\u5bf9\u5176\u91cd\u4efb\u548c\u5c97\u4f4d\u804c\u8d23\u7684\u5d07\u9ad8\u5b88\u536b\u4e0e\u6267\u884c\u3002\u76f4\u5230\u73b0\u5728\uff0cFDA\u5df2\u53d8\u6210\u5168\u4e16\u754c\u98df\u54c1\u836f\u54c1\u5b89\u5168\u987e\u5ba2\u5185\u5fc3\u7684\u91d1\u94a2\u94e0\u7532\u3002<\/p>\n<h2 style=\"margin: 0px; padding: 0px 8px 0px 18px; font-size: 22px; float: left; font-weight: 400; background-image: initial; background-position: initial; background-size: initial; background-attachment: initial; line-height: 3em;\">\u9a8c\u8bc1<\/h2>\n<p style=\"line-height: 3em;\">\u98df\u54c1\u7c7bFDA\u8ba4\u8bc1<\/p>\n<p style=\"line-height: 3em;\">FDA\u5bf9\u98df\u54c1\u7c7b\u3001\u519c\u4e1a\u4ea7\u54c1\u3001\u6d77\u9c9c\u4ea7\u54c1\u7684\u76d1\u7763\u673a\u6784\u662f\u98df\u54c1\u536b\u751f\u5b89\u5168\u4e0e\u8425\u517b\u6210\u5206\u6838\u5fc3\uff08CFSAN\uff09\uff0c\u5176\u4e3b\u8981\u804c\u8d23\u662f\u4fdd\u8bc1\u5916\u56fd\u4eba\u98df\u54c1\u7c7b\u4f9b\u8d27\u5b89\u5168\u6027\u3001\u6574\u6d01\u3001\u65b0\u9bae\u800c\u4e14\u6807\u5fd7\u6e05\u6670\u3002\u6838\u5fc3\u76d1\u7ba1\u7684\u98df\u54c1\u7c7b\u6bcf\u4e00\u5e74\u8fdb\u53e3\u76842400\u4ebf\u7f8e\u91d1\uff0c\u5728\u5176\u4e2d150\u4ebf\u5f52\u5c5e\u4e8e\u8fdb\u53e3\u5546\u54c1\uff0c\u6838\u5fc3\u7684\u5173\u952e\u68c0\u6d4b\u4e3b\u8981\u5305\u542b\uff1a<\/p>\n<p style=\"line-height: 3em;\">1\u3001 \u98df\u54c1\u7c7b\u9c9c\u5ea6\uff1b<\/p>\n<p style=\"line-height: 3em;\">2\u3001 \u98df\u7528\u6dfb\u52a0\u5242\uff1b<\/p>\n<p style=\"line-height: 3em;\">3\u3001 \u98df\u54c1\u7c7b\u751f\u7269\u4f53\u5185\u6bd2\u7d20\u5176\u4ed6\u6709\u5371\u5bb3\u6709\u6548\u6210\u5206\uff1b<\/p>\n<p style=\"line-height: 3em;\">4\u3001 \u6d77\u9c9c\u4ea7\u54c1\u5b89\u5168\u6027\u5256\u6790\uff1b<\/p>\n<p style=\"line-height: 3em;\">5\u3001 \u98df\u54c1\u7c7b\u6807\u5fd7\uff1b<\/p>\n<p style=\"line-height: 3em;\">6\u3001 \u98df\u54c1\u7c7b\u53d1\u552e\u540e\u7684\u8ffd\u8e2a\u4e0e\u8b66\u544a<\/p>\n<p style=\"line-height: 3em;\">\u4f9d\u636e\u7f8e\u56fd\u4f17\u8bae\u9662\u4e8e2003\u5e74\u6839\u636e\u7684\u53cd\u6050\u6cd5,\u82f1\u56fd\u6d77\u5916\u7684\u98df\u54c1\u884c\u4e1a\u5728\u5411\u7f8e\u51fa\u5165\u53e3\u4e4b\u524d\u52a1\u5fc5\u5411FDA\u7533\u8bf7\u6ce8\u518c, \u5e76\u5728\u51fa\u5165\u53e3\u65f6\u4e3aFDA\u5f00\u5c55\u8d27\u8fd0\u7269\u6d41\u901a\u544a.<\/p>\n<p style=\"line-height: 3em;\">\u4f9d\u7167\u300a\u7f8e\u56fd\u7b2c107-188\u516c\u5171\u6cd5\u300b \u52a1\u5fc5\u5411FDA\u5907\u6848\u7684\u56fd\u5916\u98df\u54c1\u751f\u4ea7\u751f\u4ea7\u52a0\u5de5\u516c\u53f8\u5982\u4e0b\u6240\u793a\uff1a<\/p>\n<p style=\"line-height: 3em;\">1\u3001 \u9152\u548c\u542b\u9152\u6c34\u996e\u54c1\uff1b<\/p>\n<p style=\"line-height: 3em;\">2\u3001\u00a0\u5b9d\u5b9d\u53ca\u5b9d\u5b9d\u98df\u54c1\uff1b<\/p>\n<p style=\"line-height: 3em;\">3\u3001 \u5410\u53f8\u9762\u5305\u70b9\u5fc3\u7c7b\uff1b<\/p>\n<p style=\"line-height: 3em;\">4\u3001 \u996e\u54c1\uff1b<\/p>\n<p style=\"line-height: 3em;\">5\u3001 \u7cd6\u5757\u7c7b\uff08\u5305\u542b\u6ce1\u6ce1\u7cd6\uff09\uff1b<\/p>\n<p style=\"line-height: 3em;\">6\u3001 \u6c34\u679c\u9ea6\u7247\u548c\u5373\u98df\u9ea6\u7247\u7c7b\uff1b<\/p>\n<p style=\"line-height: 3em;\">7\u3001 \u829d\u58eb\u7247\u548c\u829d\u58eb\u7247\u4ea7\u54c1\uff1b<\/p>\n<p style=\"line-height: 3em;\">8\u3001 \u5de7\u514b\u529b\u548c\u53ef\u53ef\u8c46\u98df\u54c1\u7c7b\uff1b<\/p>\n<p style=\"line-height: 3em;\">9\u3001 \u73b0\u78e8\u5496\u5561\u548c\u8336\u5546\u54c1\uff1b<\/p>\n<p style=\"line-height: 3em;\">10\u3001 \u98df\u54c1\u7c7b\u7528\u9ed1\u8272\u7d20\uff1b<\/p>\n<p style=\"line-height: 3em;\">11\u3001 \u51cf\u80a5\u7626\u8eab\u57fa\u672c\u98df\u54c1\u7c7b\u548c\u836f\u7528\u4ef7\u503c\u98df\u54c1\u7c7b\u3001\u8089\u4ee3\u7528\u54c1\uff1b<\/p>\n<p style=\"line-height: 3em;\">12\u3001 \u586b\u8865\u98df\u54c1\u7c7b\uff08\u5373\u4e2d\u56fd\u7684\u8425\u517b\u98df\u54c1\u3001\u7ef4\u4ed6\u547d\u7c7b\u836f\u7269\u53ca\u5176\u4e2d\u8349\u836f\u6750\u4ea7\u54c1\uff09\uff1b<\/p>\n<p style=\"line-height: 3em;\">13\u3001 \u8c03\u5473\u6599\uff1b<\/p>\n<p style=\"line-height: 3em;\">14\u3001 \u9c7c\u79cd\u548c\u6d77\u9c9c\u4ea7\u54c1\uff1b<\/p>\n<p style=\"line-height: 3em;\">15\u3001 \u5f80\u98df\u54c1\u7c7b\u91cc\u653e\u7f6e\u548c\u7acb\u5373\u4e0e\u98df\u7269\u4e86\u89e3\u7684\u539f\u6750\u6599\u6210\u5206\u53ca\u4ea7\u54c1\uff1b<\/p>\n<p style=\"line-height: 3em;\">16\u3001 \u98df\u7528\u6dfb\u52a0\u5242\u548c\u5b89\u5168\u6027\u7684\u8c03\u6599\u7c7b\u98df\u7528\u5177\uff1b<\/p>\n<p style=\"line-height: 3em;\">17\u3001 \u98df\u54c1\u7c7b\u4ee3\u7cd6\uff1b<\/p>\n<p style=\"line-height: 3em;\">18\u3001 \u65b0\u9c9c\u6c34\u679c\u548c\u65b0\u9c9c\u6c34\u679c\u5546\u54c1\uff1b<\/p>\n<p style=\"line-height: 3em;\">19\u3001 \u98df\u7528\u80f6\u3001\u4e73\u9176\u3001\u725b\u5976\u5e03\u4e01\u548c\u9985\uff1b<\/p>\n<p style=\"line-height: 3em;\">20\u3001 \u51b0\u6dc7\u6dcb\u548c\u4e00\u4e9b\u98df\u54c1\u7c7b\uff1b<\/p>\n<p style=\"line-height: 3em;\">21\u3001 \u4eff\u4e73\u5236\u54c1\uff1b<\/p>\n<p style=\"line-height: 3em;\">22\u3001 \u7a7a\u5fc3\u7c89\u548c\u9c9c\u9762\u6761\uff1b<\/p>\n<p style=\"line-height: 3em;\">23\u3001 \u8089\u3001\u8089\u98df\u54c1\u548c\u5bb6\u79bd\u5546\u54c1\uff1b<\/p>\n<p style=\"line-height: 3em;\">24\u3001 \u5976\u3001\u65e0\u76d0\u9ec4\u6cb9\u548c\u5e72\u4e73\u5236\u54c1\uff1b<\/p>\n<p style=\"line-height: 3em;\">25\u3001 \u4e3b\u98df\u98df\u54c1\u7c7b\u548c\u5364\u6c34\u3001\u9171\u7c7b\u548c\u7279\u70b9\u4ea7\u54c1\uff1b<\/p>\n<p style=\"line-height: 3em;\">26\u3001 \u575a\u679c\u548c\u679c\u5e72\uff1b<\/p>\n<p style=\"line-height: 3em;\">27\u3001 \u5e26\u58f3\u86cb\u548c\u852c\u83dc\u5236\u54c1\uff1b<\/p>\n<p style=\"line-height: 3em;\">28\u3001 \u751c\u54c1\uff08\u5c0f\u9ea6\u9762\u7c89\u3001\u8089\u548c\u852c\u83dc\uff09\uff1b<\/p>\n<p style=\"line-height: 3em;\">29\u3001 \u671d\u5929\u6912\u3001\u7279\u5473\u54c1\u548c\u76d0\u7b49\uff1b<\/p>\n<p style=\"line-height: 3em;\">30\u3001 \u6c64\u83dc\uff1b<\/p>\n<p style=\"line-height: 3em;\">31\u3001 \u8336\u996e\u6599\u548c\u888b\u88c5\u6c34\uff1b<\/p>\n<p style=\"line-height: 3em;\">32\u3001 \u852c\u83dc\u6c34\u679c\u548c\u852c\u83dc\u5236\u54c1\uff1b<\/p>\n<p style=\"line-height: 3em;\">33\u3001 \u83dc\u7c7d\u6cb9\uff08\u5305\u542b\u690d\u7269\u6cb9\uff09\uff1b<\/p>\n<p style=\"line-height: 3em;\">34\u3001 \u852c\u83dc\u6c34\u679c\u86cb\u6e05\u5546\u54c1\uff08\u65b9\u8089\u5236\u54c1\uff09\uff1b<\/p>\n<p style=\"line-height: 3em;\">35\u3001 \u5168\u9ea6\u9762\u5305\u98df\u54c1\u7c7b\u548c\u9762\u7c89\u52a0\u5de5\u7684\u98df\u54c1\u7c7b\u3001\u6728\u85af\u6dc0\u7c89\u7b49\uff1b<\/p>\n<p style=\"line-height: 3em;\">36\u3001 \u5173\u952e\u6216\u6240\u6709\u4f9b\u4eba\u670d\u7528\u7684\u5546\u54c1\uff1b<\/p>\n<p style=\"line-height: 3em;\">\u533b\u7597\u8bbe\u5907FDA\u8ba4\u8bc1<\/p>\n<p style=\"line-height: 3em;\">FDA\u5bf9\u533b\u7597\u8bbe\u5907\u7684\u7ba1\u7406\u65b9\u6cd5\u6839\u636e\u5668\u6750\u4e0e\u653e\u5c04\u6027\u5065\u5eb7\u4e2d\u5fc3\uff08CDRH\uff09\u5f00\u5c55\u7684\uff0c\u6838\u5fc3\u76d1\u7ba1\u533b\u7597\u8bbe\u5907\u7684\u751f\u4ea7\u5236\u9020\u3001\u5305\u88dd\u3001\u4ee3\u7406\u5546\u9075\u5faa\u6cd5\u5f8b\u6cd5\u89c4\u4e0b\u5f00\u5c55\u751f\u4ea7\u7ecf\u8425\u3002\u533b\u7597\u8bbe\u5907\u8303\u7574\u5f88\u5e7f\uff0c\u5c0f\u5230\u533b\u7528\u624b\u5957\uff0c\u5927\u81f4\u5fc3\u810f\u8d77\u535a\u5668\uff0c\u5747\u5728FDA\u76d1\u7ba1\u4e0b\uff0c\u4f9d\u636e\u8bca\u7597\u4e3b\u8981\u7528\u9014\u548c\u5bf9\u8eab\u4f53\u5f88\u6709\u53ef\u80fd\u7684\u635f\u5bb3\uff0cFDA\u5c06\u533b\u7597\u8bbe\u5907\u5206\u6210\u2160\u3001\u2161\u3001\u2162\u7c7b\uff0c\u8d8a\u9ad8\u7c7b\u578b\u76d1\u7ba1\u8d8a\u5927.<\/p>\n<p style=\"line-height: 3em;\">\u5047\u5982\u5546\u54c1\u662f\u5e02\u9762\u4e0a\u672a\u66fe\u5b58\u6709\u7684\u65b0\u5947\u521b\u9020\u53d1\u660e\uff0cFDA\u89c4\u5b9a\u751f\u4ea7\u5382\u5bb6\u8fdb\u884c\u4e25\u82db\u7684\u836f\u7269\u8bd5\u9a8c\uff0c\u5e76\u6709\u7ad9\u5f97\u4f4f\u811a\u7684\u4e34\u5e8a\u4e0e\u5e94\u7528\u7edf\u8ba1\u5b66\u76f4\u63a5\u8bc1\u636e\u8868\u660e\u5546\u54c1\u7684\u6709\u6548\u548c\u5b89\u5168\u7cfb\u6570\u3002<\/p>\n<p style=\"line-height: 3em;\">\u533b\u7597\u8bbe\u5907\u7684FDA\u8ba4\u8bc1,\u5305\u542b\uff1a\u751f\u4ea7\u5382\u5bb6\u5728FDA\u7533\u8bf7\u6ce8\u518c\u3001\u5546\u54c1\u7684FDA\u5907\u6848\u3001\u5546\u54c1\u53d1\u552e\u5907\u6848\uff08510\u8868\u5907\u6848\uff09\u3001\u5546\u54c1\u53d1\u552e\u5ba1\u6279\u51c6\u8bb8\uff08PMA\u5ba1\u6279) \u8bca\u7597\u4fdd\u5065\u5668\u68b0\u7684\u6807\u8bc6\u4e0e\u6280\u6539\u9879\u76ee\u3001\u8fc7\u5173\u3001\u5907\u6848\u3001\u53d1\u552e\u524d\u6c47\u62a5\uff0c\u987b\u9012\u4ea4\u4e0b\u5217\u539f\u6750\u6599\uff1a<\/p>\n<p style=\"line-height: 3em;\">\uff081\uff09\u5305\u88dd\u8be6\u7ec6\u7684\u6210\u54c1\u4e94\u4efd,<\/p>\n<p style=\"line-height: 3em;\">\uff082\uff09\u5668\u6750\u7ed3\u6784\u56fe\u4ee5\u53ca\u6587\u5b57\u63cf\u8ff0,<\/p>\n<p style=\"line-height: 3em;\">\uff083\uff09\u5668\u6750\u7684\u529f\u80fd\u53ca\u539f\u7406\uff1b<\/p>\n<p style=\"line-height: 3em;\">\uff084\uff09\u5668\u6750\u7684\u5b89\u5168\u7cfb\u6570\u8bba\u8ff0\u6216\u5b9e\u9a8c\u539f\u6750\u6599,<\/p>\n<p style=\"line-height: 3em;\">\uff085\uff09\u751f\u4ea7\u5236\u9020\u52a0\u5de5\u5de5\u827a\u4ecb\u7ecd,<\/p>\n<p style=\"line-height: 3em;\">\uff086\uff09\u4e34\u5e8a\u7814\u7a76\u6c47\u603b,<\/p>\n<p style=\"line-height: 3em;\">\uff087\uff09\u4ea7\u54c1\u624b\u518c. \u5982\u8be5\u5668\u6750\u5177\u5907\u653e\u5c04\u6027\u7269\u8d28\u80fd\u6216\u91ca\u653e\u51fa\u6765\u653e\u5c04\u6027\u5143\u7d20\uff0c\u52a1\u5fc5\u8be6\u7ec6\u8bf4\u660e.<\/p>\n<p style=\"line-height: 3em;\">\u533b\u7597\u8bbe\u5907\u7684\u5382\u5b50\u548c\u8bbe\u5907\u7533\u8bf7\u6ce8\u518c<\/p>\n<p style=\"line-height: 3em;\">FDA\u5bf9\u533b\u7597\u8bbe\u5907\u6709\u6e05\u6670\u548c\u4e25\u8c28\u7684\u754c\u5b9a\uff0c\u5176\u754c\u5b9a\u5982\u4e0b\u6240\u793a\uff1a\u201c\u8bf4\u767d\u4e86\u533b\u7597\u8bbe\u5907\u5c31\u662f\u6307\u5408\u4e4e\u4e0b\u8ff0\u6807\u51c6\u4e4b\u4eea\u5668\u8bbe\u5907\u3001\u8bbe\u5907\u3001\u4e13\u7528\u5de5\u5177\u3001\u673a\u68b0\u8bbe\u5907\u3001\u5668\u6750\u3001\u63d2\u8fdb\u7ba1\u3001\u8eab\u4f53\u4e4b\u5916\u5b9e\u9a8c\u8bd5\u5242\u4ee5\u53ca\u5b83\u6709\u5173\u7269\u4ef6\uff0c\u5305\u542b\u90e8\u4ef6\u3001\u96f6\u4ef6\u6216\u914d\u4ef6\uff1a\u786e\u7acb\u5217\u4e8eNational Formulary\u6216the Unite States Pharmacopeia\u6216\u524d\u8ff0\u4e8c\u8005\u7684\u9644\u5219\u4e2d\u8005\uff1b\u9884\u4f30\u5e94\u7528\u4e8e\u5c0f\u52a8\u7269\u6216\u4eba\u4eec\u75c5\u75c7\uff0c\u6216\u5176\u4ed6\u5065\u5eb7\u72b6\u51b5\u4e4b\u786e\u8bca\uff0c\u6216\u7528\u4ee5\u75c5\u75c7\u4e4b\u75ca\u6108\u3001\u7f13\u89e3\u4e0e\u6cbb\u7597\u8005\uff1b\u9884\u4f30\u5371\u5bb3\u5c0f\u52a8\u7269\u6216\u8eab\u4f53\u4eba\u4f53\u4f5c\u7528\u6216\u6784\u9020\uff0c\u4f46\u4e0d\u7ecf\u8fc7\u57fa\u7840\u4ee3\u8c22\u6765\u505a\u5230\u5176\u9996\u8981\u76ee\u5730\u8005\u201d\u3002<\/p>\n<p style=\"line-height: 3em;\">\u4ec5\u6709\u5408\u4e4e\u4ee5\u4e0a\u754c\u5b9a\u7684\u5546\u54c1\u65b9\u88ab\u5f53\u4f5c\u533b\u7597\u8bbe\u5907\uff0c\u5728\u8fd9\u91cc\u5206\u7c7b\u4e0b\uff0c\u4e0d\u4f46\u533b\u9662\u95e8\u8bca\u5185\u5404\u79cd\u5404\u6837\u4eea\u5668\u8bbe\u5907\u4e0e\u4e13\u7528\u5de5\u5177\uff0c\u5373\u4f7f\u8fde\u987e\u5ba2\u53ef\u5728\u4e00\u822c\u5e97\u94fa\u9009\u8d2d\u4e4b\u773c\u955c\u67b6\u3001\u773c\u955c\u955c\u7247\u3001\u8f6f\u6bdb\u7259\u5237\u4e0e\u6309\u6469\u4eea\u7b49\u5065\u8eab\u5668\u68b0\u7b49\u90fd\u5f52\u5c5e\u4e8eFDA\u4e4b\u7ba1\u7406\u65b9\u6cd5\u8303\u7574\u3002\u5b83\u4e0e\u4e2d\u56fd\u5bf9\u533b\u7597\u8bbe\u5907\u7684\u8bc4\u5b9a\u7a0d\u6709\u4e0d\u4e00\u6837\u3002<\/p>\n<p style=\"line-height: 3em;\">\u4f9d\u636e\u98ce\u9669\u7684\u4e0d\u4e00\u6837\uff0cFDA\u5c06\u533b\u7597\u8bbe\u5907\u5206\u6210\u4e09\u7c7b\uff08\u2160\uff0c\u2161\uff0c\u2162\uff09\uff0c\u2162\u7c7b\u5b89\u5168\u98ce\u9669\u6700\u5927\u3002FDA\u5c06\u6bcf\u4e00\u79cd\u533b\u7597\u8bbe\u5907\u90fd\u660e\u6587\u89c4\u5b9a\u5176\u4ea7\u54c1\u7c7b\u522b\u548c\u7ba1\u7406\u65b9\u6cd5\u89c4\u5b9a\uff0c\u3002\u4e00\u5207\u4e00\u79cd\u533b\u7597\u8bbe\u5907\u8981\u60f3\u8fdb\u5165\u5230\u56fd\u5916\u5e02\u573a\uff0c\u52a1\u5fc5\u6700\u5148\u641e\u6e05\u7533\u8bf7\u529e\u7406\u53d1\u552e\u4ea7\u54c1\u7c7b\u522b\u548c\u7ba1\u7406\u65b9\u6cd5\u89c4\u5b9a\u3002<\/p>\n<p style=\"line-height: 3em;\">FDA\u5bf9\u4e8e\u533b\u7597\u8bbe\u5907\u5236\u5b9a\u4e86\u5f88\u591a\u4fee\u6b63\u6848\uff0c\u5e76\u4e0d\u65f6\u5730\u5f00\u5c55\u8c03\u6574\u548c\u586b\u8865\uff0c\u4f46\u5173\u952e\u7684\u4fee\u6b63\u6848\u5e76\u4e0d\u662f\u5f88\u591a\uff0c\u5305\u62ec\uff1a\u8054\u90a6\u653f\u5e9c\u98df\u54c1\u7c7b\u3001\u836f\u7269\u4e0e\u62a4\u80a4\u54c1\u4fee\u6b63\u6848\uff08FD&amp;C Act\uff0c\u538b\u6839\u4fee\u6b63\u6848\uff09\uff1b\u7fa4\u4f17\u5065\u5eb7\u533b\u7597\u4fee\u6b63\u6848\uff1b\u516c\u5e73\u5305\u88dd\u548c\u6807\u5fd7\u4fee\u6b63\u6848\uff1b\u8eab\u5fc3\u5065\u5eb7\u548c\u5b89\u5168\u6027\u8f90\u5c04\u6e90\u64cd\u7eb5\u4fee\u6b63\u6848\uff1b\u5b89\u5168\u6027\u533b\u7597\u8bbe\u5907\u4fee\u6b63\u6848\uff1b\u667a\u80fd\u5316\u4fee\u6b63\u6848\u3002\u5bf9\u8fd9\u79cd\u4fee\u6b63\u6848\uff0cFDA\u7ed9\u4e0e\u4e86\u5341\u5206\u8be6\u5c3d\u7684\u8868\u8ff0\uff0c\u5e76\u914d\u5957\u8bbe\u65bd\u6709\u5b9e\u9645\u7684\u5b9e\u9645\u64cd\u4f5c\u89c4\u5b9a\u3002\u516c\u53f8\u5728\u65b9\u6848\u8fdb\u5230\u56fd\u5916\u5e02\u573a\u524d\uff0c\u9700\u7ec6\u5fc3\u8bc4\u5b9a\u5bf9\u4e8e\u81ea\u8eab\u5546\u54c1\u6709\u5173\u7684\u6761\u4f8b\u548c\u5b9e\u9645\u89c4\u5b9a\uff08\u5305\u542b\u4e0d\u4e00\u6837\u7684\u82f1\u56fd\u4ea7\u54c1\u6267\u884c\u6807\u51c6\u89c4\u5b9a\uff09\u3002<\/p>\n<p style=\"line-height: 3em;\">\u5728\u786e\u7acb\u4e86\u4ee5\u4e0a\u4fe1\u606f\u5185\u5bb9\u540e\uff0c\u516c\u53f8\u5c31\u53ef\u4ee5\u5f00\u59cb\u63d0\u524d\u51c6\u5907\u76f8\u5173\u7684\u7533\u8bf7\u6750\u6599\uff0c\u5e76\u6309\u4e00\u5b9a\u7a0b\u5e8f\u6d41\u7a0b\u5411FDA\u5ba1\u62a5\u4ee5\u83b7\u5f97\u51c6\u8bb8\u8ba4\u540c\u3002\u9488\u5bf9\u4e00\u5207\u5546\u54c1\uff0c\u516c\u53f8\u90fd\u9700\u5f00\u5c55\u4f01\u4e1a\u5de5\u5546\u6ce8\u518c\uff08Registration\uff09\u548c\u5546\u54c1\u5b57\u6bb5\u540d\uff08Listing\uff09\u3002\u5bf9\u2160\u4ea7\u54c1\uff08\u536047%\u4e0a\u4e0b\uff09\uff0c\u63a8\u884c\u7684\u662f\u4e00\u822c\u64cd\u7eb5\uff08General Control\uff09\uff0c\u7edd\u5927\u591a\u6570\u5546\u54c1\u53ea\u9700\u5f00\u5c55\u7533\u8bf7\u6ce8\u518c\u3001\u5b57\u6bb5\u540d\u548c\u6267\u884cGMP\u6807\u51c6\uff0c\u5546\u54c1\u5c31\u53ef\u4ee5\u8fdb\u5230\u56fd\u5916\u5e02\u573a\uff08\u5728\u5176\u4e2d\u6781\u4e2a\u522b\u5546\u54c1\u8fdeGMP\u4e5f\u514d\u9664\uff0c\u6781\u4e2a\u522b\u4fdd\u5b58\u5546\u54c1\u5219\u5e94\u5411FDA\u63d0\u4ea4510\uff08K\uff09\u7533\u8bf7\u529e\u7406\u5373PMN\uff08Premarket Notification\uff09\uff09\uff1b\u5bf9\u2161\u4ea7\u54c1\uff08\u536046%\u4e0a\u4e0b\uff09\uff0c\u63a8\u884c\u7684\u662f\u72ec\u7279\u64cd\u7eb5\uff08Special Control\uff09\uff0c\u516c\u53f8\u5728\u5b8c\u6210\u7533\u8bf7\u6ce8\u518c\u548c\u5b57\u6bb5\u540d\u540e\uff0c\u8fd8\u9700\u6267\u884cGMP\u548c\u63d0\u4ea4510\uff08K\uff09\u7533\u8bf7\u529e\u7406\uff08\u975e\u5e38\u5c11\u5546\u54c1\u662f510\uff08K\uff09\u514d\u9664\uff09\uff1b\u5bf9\u2162\u4ea7\u54c1\uff08\u53607%\u4e0a\u4e0b\uff09\uff0c\u6267\u884c\u7684\u662f\u53d1\u552e\u524d\u6279\u51c6\uff0c\u516c\u53f8\u5728\u5b8c\u6210\u7533\u8bf7\u6ce8\u518c\u548c\u5b57\u6bb5\u540d\u540e\uff0c\u987b\u6267\u884cGMP\u5e76\u5411FDA\u63d0\u4ea4PMA\uff08Premarket Application\uff09\u7533\u8bf7\u529e\u7406\uff08\u4e00\u90e8\u5206\u2162\u4ea7\u54c1\u6216\u662fPMN\uff09\u3002<\/p>\n<p style=\"line-height: 3em;\">\u5bf9\u2160\u4ea7\u54c1\uff0c\u516c\u53f8\u5411FDA\u63d0\u4ea4\u76f8\u5173\u8d44\u6599\u540e\uff0cFDA\u53ea\u5f00\u5c55\u516c\u793a\uff0c\u5e76\u65e0\u76f8\u5173\u6709\u6548\u8bc1\u4ef6\u53d1\u9001\u7ed9\u516c\u53f8\uff1b\u5bf9\u2161\u3001\u2162\u7c7b\u5668\u6750\uff0c\u516c\u53f8\u987b\u63d0\u4ea4PMN\u6216PMA\uff0cFDA\u5728\u516c\u793a\u7684\u4e0e\u6b64\u540c\u65f6\uff0c\u4f1a\u7ed9\u516c\u53f8\u4ee5\u5ba3\u5e03\u7684\u5e02\u573a\u51c6\u5165\u5236\u5ea6\u51c6\u8bb8\u4fe1\u4ef6\uff08Clearance\uff09\uff0c\u5373\u5bb9\u8bb8\u516c\u53f8\u4ee5\u81ea\u5df2\u7684\u4e3a\u540d\u5728\u56fd\u5916\u533b\u7597\u8bbe\u5907\u9500\u552e\u5e02\u573a\u4e0a\u7acb\u5373\u5e02\u573a\u9500\u552e\u5176\u5546\u54c1\u3002\u5bf9\u4e8e\u7533\u8bf7\u529e\u7406\u6d41\u7a0b\u4e2d\u662f\u4e0d\u662f\u5230\u516c\u53f8\u5f00\u5c55\u5f53\u573aGMP\u8003\u8bc4\uff0c\u5219\u7531FDA\u4f9d\u636e\u5546\u54c1\u5b89\u5168\u98ce\u9669\u3001\u7ba1\u7406\u65b9\u6cd5\u9700\u8981\u548c\u9500\u552e\u5e02\u573a\u610f\u89c1\u53cd\u9988\u7b49\u7efc\u5408\u6027\u8981\u7d20\u51b3\u7b56\u3002<\/p>\n<p style=\"line-height: 3em;\">\u7efc\u5408\u6027\u4ee5\u4e0a\u5185\u5bb9\u5f97\u77e5\uff0c\u7edd\u5927\u591a\u6570\u5546\u54c1\u5728\u5f00\u5c55\u4f01\u4e1a\u5de5\u5546\u6ce8\u518c\u3001\u5546\u54c1\u5b57\u6bb5\u540d\u548c\u6267\u884cGMP\uff0c\u6216\u518d\u63d0\u4ea4510\uff08K\uff09\u7533\u8bf7\u529e\u7406\u540e\uff0c\u5c31\u53ef\u4ee5\u5f97\u5230FDA\u51c6\u8bb8\u53d1\u552e\u3002<\/p>\n<p style=\"line-height: 3em;\">1\uff0e510(K)\u6587\u6863\u4e5f\u5373FDA\u5bf9PMN\u9700\u8981\u7684\u6587\u6863\uff0c\u56e0\u5176\u76f8\u5bf9\u5e94FD&amp;C Act\u7b2c510\u7ae0\u8282\u76ee\u5f55\uff0c\u6545\u901a\u5e38\u79f0510\uff08K\uff09\u6587\u6863\u3002<\/p>\n<p style=\"line-height: 3em;\">2\uff0e\u672c\u8d28\u76f8\u540c\u6027\u8f83\u4e3a\uff08SE\uff09<\/p>\n<p style=\"line-height: 3em;\">3\uff0e510\uff08K\uff09\u6838\u67e5\u7a0b\u5e8f\u6d41\u7a0b<\/p>\n<p style=\"line-height: 3em;\">\u5728\u7533\u8bf7\u529e\u7406\u524d\u52a1\u5fc5\u786e\u7acb\u5546\u54c1\u662f\u4e0d\u662f\u88abFDA\u8ba4\u505a\u533b\u7597\u8bbe\u5907\u3001\u4ea7\u54c1\u7c7b\u578b\u3001\u7ba1\u7406\u65b9\u6cd5\u89c4\u5b9a\uff0c\u786e\u7acb\u7533\u8bf7\u529e\u7406\u5de5\u4f5c\u4efb\u52a1\uff1b<\/p>\n<p style=\"line-height: 3em;\">\u5bf9\u7533\u8bf7\u529e\u7406\u53d1\u552e\u7684\u5546\u54c1\u67e5\u770b\u6709\u65e0\u82f1\u56fd\u5f3a\u5236\u6027\u89c4\u8303\uff0c\u5546\u54c1\u662f\u4e0d\u662f\u5408\u4e4e\u8be5\u89c4\u8303\uff08\u4e00\u822c\u89c4\u5b9a\u68c0\u6d4b\u4e2d\u5fc3\u7684\u5ba3\u5e03\u68c0\u6d4b\u62a5\u544a\uff09\uff1b<\/p>\n<p style=\"line-height: 3em;\">\u5728\u63d0\u524d\u51c6\u5907510\uff08K\uff09\u7533\u8bf7\u529e\u7406\u6587\u6863\u524d\uff0c\u9700\u8003\u8651\u5230\u662f\u4e0d\u662f\u786e\u5b9e\u5fc5\u987b\u63d0\u4ea4\u3001\u4ec0\u4e48\u65f6\u5019\u63d0\u4ea4\u53ca\u5176\u63d0\u4ea4\u54ea\u4e00\u79cd\u7279\u6027\u7684510\uff08K\uff09\u7533\u8bf7\u529e\u7406\uff1a\u57fa\u672c510\uff08K\uff09\u3001\u72ec\u7279510\uff08K\uff09\u3001\u7b80\u5355\u5316510\uff08K\uff09\uff1b<\/p>\n<p style=\"line-height: 3em;\">\u5bf9\u7533\u8bf7\u529e\u7406\u6d41\u7a0b\u4e2dFDA\u6240\u786e\u7acb\u7684\u95ee\u9898\u5e94\u7acb\u5373\u7ed9\u4e0e\u4e66\u9762\u5f62\u5f0f\u7684\u3001\u7acb\u5373\u7684\u56de\u5e94\uff1b<\/p>\n<p style=\"line-height: 3em;\">\u5411FDA\u63d0\u4ea4\u7684\u5168\u90e8\u6750\u6599\u7eb8\u5f20\u5c3a\u5bf8\u5e94\u9009\u7528Letter Size\uff0821.5cm X 29.7cm\uff09\uff1b<\/p>\n<p style=\"line-height: 3em;\">\u5168\u90e8\u63d0\u4ea4FDA\u7684\u6750\u6599\u516c\u53f8\u9700\u7559\u51fa\u5907\u4efd\u6570\u636e\uff0c\u7531\u4e8eFDA\u5728\u63a5\u5230\u7533\u8bf7\u529e\u7406\u6750\u6599\u540e\u5373\u626b\u63cf\u767b\u9646\uff0c\u4e0e\u6b64\u540c\u65f6\u6d88\u6bc1\u7533\u8bf7\u529e\u7406\u6750\u6599\uff0c\u5e76\u4e0d\u507f\u8fd8\u516c\u53f8\u3002<\/p>\n<p style=\"line-height: 3em;\">\u5bf9\u4e00\u5c0f\u90e8\u5206\u5546\u54c1\uff0cFDA\u5c06\u5bf9\u516c\u53f8\u5f00\u5c55\u5f53\u573aGMP\u8003\u8bc4\uff0c\u516c\u53f8\u9700\u53c2\u8003\u82f1\u56fdGMP\u7ba1\u7406\u65b9\u6cd5\u89c4\u5b9a\uff0c\u5e76\u5728FDA\u5f53\u573a\u5ba1\u6279\u65f6\u914d\u7f6e\u9002\u5408\u7684\u3001\u5bf9GMP\u548c\u516c\u53f8\u6709\u4e00\u5b9a\u660e\u767d\u7684\u7ffb\u8bd1\u5458\uff1b<\/p>\n<p style=\"line-height: 3em;\">\u544a\u4e4bFDA\u7684\u5ba3\u5e03\u624b\u673a\u8054\u7cfb\u4eba\u9700\u5bf9FDA\u653f\u7b56\u6cd5\u89c4\u548c\u5de5\u4f5c\u4e2d\u7a0b\u5e8f\u6d41\u7a0b\u6709\u4e00\u5b9a\u7684\u638c\u63e1\uff0c\u5e76\u4e14\u80fd\u591f\u4e0eFDA\u7acb\u5373\u6c9f\u901a\u4ea4\u6d41\uff0c\u4ee5\u4fbf\u6377\u53ca\u65f6\u53cd\u9988\uff0c\u516c\u53f8\u53ef\u786e\u7acb\u81ea\u8eab\u6216\u6388\u6743\u59d4\u6258\u54a8\u8be2\u7ba1\u7406\u516c\u53f8\u627f\u62c5\u4e0eFDA\u7684\u65e5\u5e38\u6c9f\u901a\u4ea4\u6d41\u3002<\/p>\n<p style=\"line-height: 3em;\">\u62a4\u80a4\u54c1FDA\u8ba4\u8bc1<\/p>\n<p style=\"line-height: 3em;\"><em>\u62a4\u80a4\u54c1\u81ea\u884c\u7533\u8bf7\u6ce8\u518c\u65b9\u6848\uff08VCRP\uff09<\/em><\/p>\n<p><img decoding=\"async\" style=\"border: 0px; margin: 0px auto; width: 155px; height: 220px;\" src=\"\/wp-content\/uploads\/2021\/12\/20211215140549-61b9f63d712b7.jpg\" alt=\"\u5316\u5986\u54c1FDA\u8bc1\u4e66\u6837\u672c\" \/><\/p>\n<p style=\"font-size: 12px; text-indent: 0px; font-family: 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3em;\">\u751f\u4ea7\u5382\u5bb6\u81ea\u884c\u7533\u8bf7\u6ce8\u518c\u5e76\u5f97\u5230\u5de5\u5546\u6ce8\u518c\u53f7\u5e76\u4e0d\u4ee3\u8868FDA\u5bf9\u8be5\u751f\u4ea7\u5382\u5bb6\u6216\u5176\u5546\u54c1\u7684\u51c6\u8bb8\uff0cFDA\u4e5f\u4e0d\u5141\u8bb8\u751f\u4ea7\u5382\u5bb6\u8fd0\u7528\u53c2\u52a0VCRP\u6216\u83b7\u5f97\u7684\u5de5\u5546\u6ce8\u518c\u53f7\u6216\u5b57\u6bb5\u540d\u53f7\u5f00\u5c55\u5546\u4e1a\u670d\u52a1\u5ba3\u4f20\u7b56\u5212\uff1b\u4f46\u751f\u4ea7\u5382\u5bb6\u53ef\u4ee5\u6839\u636e\u53c2\u52a0VCRP\u7acb\u5373\u5f97\u5230\u4ee5\u4e0b\u6743\u76ca\uff1a<\/p>\n<p style=\"line-height: 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\u534f\u52a9\u96f6\u552e\u5546\u9274\u522b\u6709\u5b89\u5168\u9632\u8303\u610f\u8bc6\u7684\u751f\u4ea7\u5382\u5bb6\u3002\u96f6\u552e\u5546\uff08\u6bd4\u5982\u767e\u8d27\u5546\u5e97\uff09\u6709\u65f6\u5019\u4e86\u89e3FDA\u4e00\u5bb6\u7f8e\u5bb9\u516c\u53f8\u662f\u4e0d\u662f\u5728FDA\u7533\u8bf7\u6ce8\u518c\u8fc7\u3002\u5c3d\u7ba1\u7533\u8bf7\u6ce8\u518c\u5e76\u4e0d\u4ee3\u8868FDA\u51c6\u8bb8\uff0c\u4f46\u5b83\u8868\u660e\u4f60\u7684\u5546\u54c1\u901a\u8fc7\u4e86FDA\u7684\u5ba1\u67e5\u800c\u4e14\u8fdb\u5165\u4e86\u653f\u5e9c\u90e8\u95e8\u7684\u6570\u636e\u5e93\u67e5\u8be2\u3002\u5047\u5982\u4f60\u9012\u4ea4\u7684\u5546\u54c1\u79d8\u65b9\u4e0d\u8be6\u7ec6\uff0c\u6216\u662f\u5305\u62ec\u67d0\u7c7b\u7981\u6b62\u4f7f\u7528\u6210\u4efd\u6216\u6ca1\u7ecf\u51c6\u8bb8\u7684\u9ed1\u8272\u7d20\u6dfb\u52a0\u7269\uff0cFDA\u4f1a\u901a\u544a\u4f60\u3002<\/p>\n<p style=\"line-height: 3em;\">\u6536\u96c6\u8bd5\u6837\u7684\u51b3\u7b56\u6839\u636e\u5546\u54c1\u7684\u7279\u6027\uff1bFDA\u91cd\u70b9\u5173\u6ce8\u7684\u95ee\u9898\uff1b\u5546\u54c1\u7684\u8fc7\u53bb\u5386\u53f2\u65f6\u95f4\u3002FDA\u83b7\u5f97\u4e00\u7269\u7406\u5b66\u8bd5\u54c1\u5e76\u5c06\u5b83\u9001\u81f3FDA\u5730\u57df\u8bd5\u9a8c\u5ba4\u5f00\u5c55\u5256\u6790<\/p>\n<p style=\"line-height: 3em;\">\u5047\u5982FDA\u53d1\u89c9\u8bd5\u54c1\u7b26\u5408\u89c4\u5b9a\uff0c\u5219\u5404\u81ea\u5411\u7f8e\u56fd\u6d77\u5173\u548c\u91c7\u8d2d\u5546\u63a8\u9001\u4e00\u4efd\\&#8221;\u6d77\u5173\u653e\u884c\u901a\u77e5\u5355\\&#8221;\u3002<\/p>\n<p style=\"line-height: 3em;\">\u5047\u5982FDA\u5224\u65ad\uff0c\u8bd5\u54c1\\&#8221;\u6709\u8fdd\u80ccFDCA\u548c\u5176\u4ed6\u76f8\u5173\u6cd5\u5f8b\u6cd5\u89c4\u7684\u4e3b\u8981\u8868\u73b0\\&#8221;\uff0c\u5219\u5404\u81ea\u5411\u7f8e\u56fd\u6d77\u5173\u548c\u6848\u53ca\u91c7\u8d2d\u5546\u63a8\u9001\\&#8221;\u6263\u7559\u548c\u542c\u8bc1\u901a\u77e5\u4e66\\&#8221;\u3002\u901a\u77e5\u5355\u8be6\u7ec6\u63cf\u8ff0\u8fdd\u53cd\u89c4\u5b9a\u548c\u7279\u6027\u5e76\u7ed9\u6848\u53ca\u91c7\u8d2d\u554610\u4e2a\u5de5\u4f5c\u4e2d\u65e5\u4ee5\u7ed9\u4e88\u8be5\u6279\u8d27\u54c1\u53ef\u83b7\u51c6\u4e88\u7684\u76f4\u63a5\u8bc1\u636e\u3002<\/p>\n<p style=\"line-height: 3em;\">\u5df2\u6263\u7559\u7684\u8fdb\u53e3\u5546\u54c1\u52a1\u5fc5\u5728FDA\u6216\u7f8e\u56fd\u6d77\u5173\u7684\u76d1\u7ba1\u4e0b\u6574\u4fee\uff0c\u81ea\u4f53\u8840\u56de\u8f93\u6216\u6d88\u6bc1<\/p>\n<p style=\"line-height: 3em;\">\u542c\u8bc1\u4f1a\u7a0b\u5e8f\u662f\u91c7\u8d2d\u5546\u4e3a\u8fdb\u53e3\u7684\u7269\u4ef6\u5f00\u5c55\u8fa9\u89e3\u6216\u7ed9\u4e88\u76f4\u63a5\u8bc1\u636e\u53ef\u4ee5\u4f7f\u8d27\u54c1\u901a\u8fc7\u6574\u4fee\u540e\u5408\u9002\u4e8e\u5165\u5173\u7684\u673a\u9047\u3002<\/p>\n<p style=\"line-height: 3em;\">\u5047\u5982\u6848\u53ca\u4e3b\u627f\u9500\u3001\u8d27\u4e3b\u3001\u91c7\u8d2d\u5546\u6216\u4e00\u7279\u5b9a\u610f\u5473\u7740\u4e0d\u56de\u5e94\u901a\u77e5\u5355\uff0cFDA\u5411\u7f8e\u56fd\u6d77\u5173\u548c\u6848\u53ca\u91c7\u8d2d\u5546\u63a8\u9001\\&#8221;\u62d2\u5165\u901a\u77e5\u5355\\&#8221;\u3002\u800c\u540e\u95ee\u9898\u6240\u81f3\u7684\u5546\u54c1\u81ea\u4f53\u8840\u56de\u8f93\u6216\u6d88\u6bc1\u3002<\/p>\n<p style=\"line-height: 3em;\">\u5047\u5982\u6848\u53ca\u4e3b\u627f\u9500\u3001\u8d27\u4e3b\u3001\u91c7\u8d2d\u5546\u6216\u4e00\u7279\u5b9a\u610f\u5473\u7740\u56de\u5e94\u4e86\\&#8221;\u6263\u7559\u548c\u542c\u8bc1\u901a\u77e5\u4e66\\&#8221;\uff0c\u5f53\u91c7\u8d2d\u5546\u7ed9\u4e88\u76f4\u63a5\u8bc1\u636e\u8868\u660e\u5546\u54c1\\&#8221;\u7b26\u5408\u89c4\u5b9a\\&#8221;\u6216\u9012\u4ea4\u6574\u4fee\u5546\u54c1\u7684\u7533\u8bf7\u62a5\u544a\u65f6\uff0cFDA\u5c31\u5df2\u6263\u7559\u7684\u5546\u54c1\u4e3e\u529e\u542c\u8bc1\u4f1a\u7a0b\u5e8f\u3002<\/p>\n<p style=\"line-height: 3em;\">\u5047\u5982\u5546\u6807\u7ed9\u4e88\u4e86\u5546\u54c1\u7b26\u5408\u89c4\u5b9a\u7684\u76f4\u63a5\u8bc1\u636e\uff0cFDA\u5c06\u6536\u96c6\u540e\u9762\u8bd5\u54c1\u3002\u5f85\u5256\u6790\u540e\u51b3\u7b56\uff0c\u5546\u54c1\u6216\u8005\u88ab\u6d77\u5173\u653e\u884c\u6216\u8005\u88ab\u62d2\u7edd\u5165\u5883\u3002<\/p>\n<p style=\"line-height: 3em;\">FDA\u5ba1\u6279\u91c7\u8d2d\u5546\u62df\u8bae\u7684\u6574\u4fee\u7a0b\u5e8f\u6d41\u7a0b\uff0c\u89c6\u72b6\u51b5\u7ed9\u4e88\u51c6\u8bb8\u6216\u4e0d\u4e88\u4ee5\u51c6\u8bb8\u3002\u4e00\u65e6\u51c6\u8bb8\uff0cFDA\u5c06\u5f00\u5c55\u540e\u9762\u68c0\u6d4b\/\u8bd5\u54c1\u6536\u96c6\u4ee5\u786e\u8ba4\u5176\u8fbe\u6807\u6027\u3002\u5047\u5982\u8bd5\u54c1\u8fbe\u6807\uff0c\u5411\u7f8e\u56fd\u6d77\u5173\u548c\u91c7\u8d2d\u5546\u63a8\u9001\\&#8221;\u6d77\u5173\u653e\u884c\u901a\u77e5\u5355\\&#8221;\u3002\u53d1\u679c\u8bd5\u54c1\u4e0d\u8fc7\u5173\uff0c\u51fa\\&#8221;\u62d2\u5165\u901a\u77e5\u5355\\&#8221;\u3002<\/p>\n<p style=\"line-height: 3em;\">FDCA\u7684\u7b2c8\uff08C\uff09\u8282\u89c4\u5b9a\u7533\u8bf7\u8005\u4ed8\u6b3e\u6240\u6709\u82b1\u8d39\uff0c\u9664\u5347\u7ea7\u6807\u8bc6\u6216\u5176\u4ed6\u4f7f\u6263\u7559\u4ea7\u54c1\u5408\u4e4e\u7533\u8bf7\u62a5\u544a\uff08FDA-766\u62a5\u8868\uff09\u6761\u6587\u4e2d\u76f8\u5173\u5bf9\u7b56\u7684\u6210\u672c\u5916\uff0c\u8fd8\u5305\u542bFDA\u9ad8\u5b98\u6216\u804c\u5458\u7684\u5dee\u65c5\u8d39\u3001\u65e5\u7528\u548c\u85aa\u6c34\u3002\u6839\u636e\u9012\u4ea4FDA-766\u62a5\u8868\uff0c\u7533\u8bf7\u8005\u5141\u8bb8\u6309\u73b0\u884c\u6807\u51c6\u653f\u7b56\u6cd5\u89c4\u4ed8\u6b3e\u6240\u6709\u7ba1\u63a7\u82b1\u8d39\u3002<\/p>\n<p style=\"line-height: 3em;\">\u836f\u7269\u3001\u751f\u7269\u5236\u836fFDA\u8ba4\u8bc1<\/p>\n<p style=\"line-height: 3em;\">FDA\u5bf9\u836f\u4e1a\u5546\u54c1\u6709\u4e00\u6574\u5957\u5b8c\u5584\u7684\u9a8c\u8bc1\u7a0b\u5e8f\u6d41\u7a0b\u4fbf\u4e8e\u4fdd\u8bc1\u836f\u7269\u7684\u5b89\u5168\u9632\u62a4\u4e0e\u5408\u7406.\u8be5\u7a0b\u5e8f\u6d41\u7a0b\u5982\u4e0b\u6240\u793a:<\/p>\n<p style=\"line-height: 3em;\"><em>1. \u63a2\u7a76\u6027\u836f\u7269\u5ba1\u8bf7 (IND):<\/em><\/p>\n<p style=\"line-height: 3em;\">\u5f53\u836f\u4e1a\u516c\u53f8\u5411FDA\u63d0\u4ea4IND, FDA\u5bf9\u836f\u7269\u7684\u68c0\u6d4b\u5f00\u59cb\u4e86.\u8fd9\u65f6\u836f\u7269\u7684\u836f\u7269\u8bd5\u9a8c\u5e76\u672a\u9010\u6e10, FDA\u5173\u952e\u5ba1\u6279\u8eab\u4f53\u4e4b\u5916\u5b89\u5168\u6027\u6570\u636e\u4fe1\u606f\u4e0e\u5c0f\u52a8\u7269\u6d4b\u8bd5\u6570\u636e,\u4ee5\u51b3\u7b56\u6b64\u836f\u662f\u4e0d\u662f\u5145\u8db3\u5b89\u5168\u6027\u8fdb\u5230\u836f\u7269\u8bd5\u9a8c\u73af\u8282.<\/p>\n<p style=\"line-height: 3em;\"><em>2.\u836f\u7269\u8bd5\u9a8c:<\/em><\/p>\n<p style=\"line-height: 3em;\">\u836f\u7269\u8bd5\u9a8c\u5171\u67094\u4e2a\u73af\u8282. \u4e00\u671f\u5173\u952e\u68c0\u6d4b\u836f\u54c1\u7684\u5b89\u5168\u7cfb\u6570, \u5173\u952e\u4e0d\u826f\u53cd\u5e94, \u65b0\u9648\u4ee3\u8c22\u539f\u7406,\u7b49, \u6837\u672c\u91cf\u4e00\u822c\u4f4e\u4e8e200.<\/p>\n<p style=\"line-height: 3em;\">\u4e8c\u671f\u5173\u952e\u68c0\u6d4b\u836f\u54c1\u7684\u5b9e\u6548\u6027, \u4ee5\u51b3\u7b56\u836f\u7269\u662f\u4e0d\u662f\u80fd\u5408\u7406\u7684\u529f\u6548\u4e8e\u8eab\u4f53. \u4e0e\u6b64\u540c\u65f6,\u836f\u7269\u7684\u7a33\u5b9a\u6027\u4e0e\u526f\u4f5c\u7528\u4e5f\u662f\u7d27\u5bc6\u89c2\u67e5\u7684\u76ee\u6807. \u4e8c\u671f\u8bd5\u9a8c\u7684\u6837\u672c\u91cf\u4e00\u822c\u4f4e\u4e8e300.<\/p>\n<p style=\"line-height: 3em;\">\u5047\u5982\u4e8c\u671f\u8bd5\u9a8c\u50ac\u4eba\u594b\u8fdb, \u5219\u66f4\u9ad8\u7684\u6837\u7248\u5c06\u5907\u68c0\u6d4b, \u8bd5\u9a8c\u8fdb\u5230\u4e09\u671f. \u4e09\u671f\u5c06\u5305\u542b\u4e0d\u4e00\u6837\u7684\u5e74\u9f84\u5c42,\u4e0d\u4e00\u6837\u7684\u7269\u79cd, \u4e0e\u4e0d\u4e00\u6837\u7684\u836f\u91cf, \u4ee5\u5168\u65b9\u4f4d\u7684\u79d1\u5b66\u7814\u7a76\u836f\u7684\u7a33\u5b9a\u6027\u4e0e\u5b9e\u6548\u6027. \u4e09\u671f\u8bd5\u9a8c\u7684\u6837\u672c\u91cf\u5728\u597d\u51e0\u767e\u5230\u51e0\u5343\u5143\u4e0d\u4e00.<\/p>\n<p style=\"line-height: 3em;\">\u56db\u671f\u5173\u952e\u5728\u836f\u7269\u51c6\u8bb8\u540e\u5f00\u5c55, \u5173\u952e\u68c0\u6d4b\u836f\u54c1\u7684\u957f\u671f\u6027\u5b89\u5168\u7cfb\u6570, \u65b0\u7684\u7269\u79cd,\u7b49.<\/p>\n<p style=\"line-height: 3em;\"><em>3.\u836f\u7269\u7533\u8bf7\u529e\u7406 New Drug Application(NDA)\u3001\u751f\u7269\u5236\u836f\u6279\u51c6\u7533\u8bf7\u529e\u7406 Biologic License Application\uff08BLA):<\/em><\/p>\n<p style=\"line-height: 3em;\">\u5f53\u836f\u4e1a\u516c\u53f8\u5b8c\u6210\u4e86\u836f\u7269\u8bd5\u9a8c,\u8ba4\u8bc1\u4e86\u836f\u7269\u7684\u5b89\u5168\u6027\u53ef\u9760\u540e, \u5ba3\u5e03\u5411FDA\u9012\u4ea4NDA\u7533\u8bf7\u529e\u7406. FDA\u5ba1\u6279\u6240\u6709\u7684\u5c0f\u52a8\u7269\u4e0e\u836f\u7269\u8bd5\u9a8c\u6570\u636e\u4fe1\u606f,\u53ca\u5176\u7528\u836f\u7684\u4ee3\u89e3\u4f53\u5236\u6570\u636e\u4fe1\u606f, \u836f\u54c1\u751f\u4ea7\u5236\u9020\u7684GMP\u6570\u636e\u4fe1\u606f, \u5047\u5982\u6570\u636e\u4fe1\u606f\u4e0d\u5168\u6216\u4e0d\u79d1\u5b66, FDA\u4f1a\u56de\u7edd\u7533\u7406, \u4e0d\u7136FDA\u4f1a\u572810\u4e2a\u6708\u4e0a\u4e0b\u7533\u6838\u7ed3\u675f,\u7ed9\u4e0e\u5141\u8bb8\u6216\u56de\u7edd\u5efa\u8bae.<\/p>\n<p style=\"line-height: 3em;\">\u98df\u54c1\u7c7b\u539f\u6750\u6599FDA\u8ba4\u8bc1<\/p>\n<p style=\"line-height: 3em;\">\u98df\u54c1\u7c7b\u89e6\u78b0\u7c7b\u539f\u6750\u6599\u6307\u4e00\u5207\u7528\u4ee5\u751f\u4ea7\u52a0\u5de5\u3001\u751f\u4ea7\u5236\u9020\u3001\u5305\u88dd\u3001\u50a8\u5b58\u53ca\u8fd0\u9001\u98df\u54c1\u7c7b\u5168\u8fc7\u7a0b\u4e2d\u3001\u4e0e\u98df\u54c1\u7c7b\u53ef\u4ee5\u89e6\u53ca\u5230\u7684\u539f\u6750\u6599.\u666e\u904d\u7684\u539f\u6750\u6599\u5305\u542b\u5404\u79cd\u5404\u6837\u5851\u80f6\u3001\u91d1\u5c5e\u6750\u6599\u3001\u74f7\u5668\u3001\u5939\u5c42\u73bb\u7483\u3001\u7af9\u6750\u4ea7\u54c1\u7b49\u3002\u8fd9\u79cd\u4e0e\u98df\u54c1\u7c7b\u53ef\u4ee5\u89e6\u53ca\u5230\u7684\u6750\u8d28\u7684\u73af\u5883\u4fdd\u62a4\u5b89\u5168\u6027\u72b6\u51b5\u7acb\u5373\u5173\u4e4e\u7528\u6237\u7684\u996e\u98df\u536b\u751f\u5b89\u5168\u548c\u8eab\u5fc3\u5065\u5eb7\u3002\u56e0\u6b64\u5bf9\u8fd9\u79cd\u51fa\u53e3\u4ea7\u54c1\u5230\u82f1\u56fd\u5fc5\u987b\u4f9d\u7167FDA\u89c4\u8303\u5f00\u5c55\u76f8\u5e94\u7684\u68c0\u6d4b\u8ba4\u8bc1\u3002<\/p>\n<p style=\"line-height: 3em;\">\u666e\u904d\u4e0e\u98df\u7269\u89e6\u78b0\u539f\u6750\u6599FDA\u8ba4\u8bc1\u68c0\u9a8c\u65b0\u9879\u76ee\u5982\u4e0b\u6240\u793a\uff1a<\/p>\n<p style=\"line-height: 3em;\">\u25a0\u6709\u673a\u6d82\u5c42, \u91d1\u5c5e\u6750\u6599\u548c\u7535\u9540\u5de5\u827a\u4ea7\u54c1\u89c4\u5b9aU.S. FDA CFR 21 175.300.<\/p>\n<p style=\"line-height: 3em;\">\u53bb\u79bb\u5b50\u6c34\u6d78\u53d6\u6cd5\u30018%\u4e59\u9187\u6d78\u53d6\u6cd5\u3001\u6b63\u5e9a\u70f7\u6d78\u53d6\u6cd5<\/p>\n<p style=\"line-height: 3em;\">\u25a0\u7eb8\u5305\u88c5\u5236\u54c1\u89c4\u5b9a U.S. FDA CFR 21 176.170<\/p>\n<p style=\"line-height: 3em;\">\u4e59\u919a\u53ef\u6eb6\u89e3\u63d0\u7eaf\u7269\uff08\u53bb\u79bb\u5b50\u6c34\u6d78\u53d6\u6cd5\u30018%\u4e59\u9187\u6d78\u53d6\u6cd5\u300150%\u4e59\u9187\u6d78\u53d6\u6cd5\u3001\u6b63\u5e9a\u70f7\u6d78\u53d6\u6cd5\uff09<\/p>\n<p style=\"line-height: 3em;\">\u25a0\u6728\u6599\u89c4\u5b9aU.S. FDA CFR 21 178.3800<\/p>\n<p style=\"line-height: 3em;\">\u4e94\u6c2f\u7532\u9178PCP<\/p>\n<p style=\"line-height: 3em;\">\u25a0ABS\u89c4\u5b9aU.S. FDA CFR 21 181.32 or 180.22.<\/p>\n<p style=\"line-height: 3em;\">\u53bb\u79bb\u5b50\u6c34\u6d78\u53d6\u6cd5\u30013%\u51b0\u918b\u9178\u6d78\u53d6\u6cd5\u30018%\u4e59\u9187\u6d78\u53d6\u6cd5\u3001\u6b63\u5e9a\u70f7\u6d78\u53d6\u6cd5<\/p>\n<p style=\"line-height: 3em;\">\u25a0\u4e19\u70ef\u9178\u4e73\u6db2\uff08Acrylic\uff09\u89c4\u5b9aU.S. FDA CFR 21 177.1010<\/p>\n<p style=\"line-height: 3em;\">\u603b\u690d\u7269\u753e\u9187\uff08in water,8%,50%alcohol fraction,heptane\uff09\u53bb\u79bb\u5b50\u6c34\u30018%\u4e59\u9187<\/p>\n<p style=\"line-height: 3em;\">KMnO4 oxidizable extractive(in water,8%,50%alcohol fraction)<\/p>\n<p style=\"line-height: 3em;\">Ultraviolet-absorbing(in water,8%,50%alcohol fraction)<\/p>\n<p style=\"line-height: 3em;\">Ultraviolet-absorbing(in heptane fraction)<\/p>\n<p style=\"line-height: 3em;\">\u25a0\u98df\u54c1\u5305\u88c5\u6750\u6599\u7684\u5bc6\u5c01\u73af\uff0c\u5bc6\u5c01\u6027\u57ab\u7247\u89c4\u5b9a\uff0c\u5982\u7845\u80f6\u5708 U.S. FDA CFR 21 177.1210<\/p>\n<p style=\"line-height: 3em;\">\u4e59\u919a\u53ef\u6eb6\u89e3\u63d0\u7eaf\u7269<\/p>\n<p style=\"line-height: 3em;\">\u25a0EVA\u89c4\u5b9a U.S. FDA CFR 21 177.1350<\/p>\n<p style=\"line-height: 3em;\">\u4e59\u919a\u63d0\u7eaf<\/p>\n<p style=\"line-height: 3em;\">\u25a0\u4e09\u805a\u6c30\u6c28\u73af\u6c27\u6811\u8102(\u5bc6\u80fa\u9910\u5177)\u89c4\u5b9a U.S. FDA CFR 21 177.1460<\/p>\n<p style=\"line-height: 3em;\">\u4e59\u919a\u53ef\u6eb6\u89e3\u63d0\u7eaf\u7269<\/p>\n<p style=\"line-height: 3em;\">\u25a0\u6da4\u7eb6\u5851\u80f6\u89c4\u5b9a U.S. FDA CFR 21 177.1500<\/p>\n<p style=\"line-height: 3em;\">\u76f8\u5bf9\u5bc6\u5ea6\u3001\u6eb6\u70b9\u3001\u786b\u9178\u4e2d\u7684\u6eb6\u89e3\u6027\u3001\u53bb\u79bb\u5b50\u6c34\u6d78\u53d6\u6cd5\u300195%\u4e59\u9187\u6d78\u53d6\u6cd5\u3001\u7532\u9178\u4e59\u8102\u6d78\u53d6\u6cd5\u3001\u82ef\u6d78\u53d6\u6cd5<\/p>\n<p style=\"line-height: 3em;\">\u25a0PP\u89c4\u5b9a U.S. FDA CFR 21 177.1520<\/p>\n<p style=\"line-height: 3em;\">\u76f8\u5bf9\u5bc6\u5ea6\u3001\u6eb6\u70b9\u3001\u6b63\u5df1\u70f7\u6d78\u53d6\u6cd5\u3001\u4e8c\u7532\u82ef\u6d78\u53d6\u6cd5 ..<\/p>\n<p style=\"line-height: 3em;\">\u25a0 PE,OP\u89c4\u5b9a U.S. FDA CFR 21 177.1520<\/p>\n<p style=\"line-height: 3em;\">\u76f8\u5bf9\u5bc6\u5ea6\u3001\u6b63\u5df1\u70f7\u6d78\u53d6\u6cd5\u3001\u4e8c\u7532\u82ef\u6d78\u53d6\u6cd5<\/p>\n<p style=\"line-height: 3em;\">\u25a0 PC\u89c4\u5b9a.U.S. FDA CFR 21 177.1580<\/p>\n<p style=\"line-height: 3em;\">\u6c34\u6d41\u56de\u63d0\u7eaf\u300150%\u4e59\u9187\u6d41\u56de\u63d0\u7eaf\u3001\u6b63\u5e9a\u70f7\u6d41\u56de\u63d0\u7eaf<\/p>\n<p style=\"line-height: 3em;\">\u25a0PET\u89c4\u5b9a U.S. FDA CFR 21 177.1630 .<\/p>\n<p style=\"line-height: 3em;\">\u4e59\u919a\u53ef\u6eb6\u89e3\u63d0\u7eaf\u7269\uff08\u53bb\u79bb\u5b50\u6c34\u6d78\u53d6\u6cd5\u30018%\u4e59\u9187\u6d78\u53d6\u6cd5\u300195%\u4e59\u9187\u6d78\u53d6\u6cd5\u3001\u6b63\u5e9a\u70f7\u6d78\u53d6\u6cd5\uff09<\/p>\n<p style=\"line-height: 3em;\">\u25a0 PS \u89c4\u5b9a U.S. FDA CFR 21 177.1640<\/p>\n<p style=\"line-height: 3em;\">\u4e01\u4e8c\u70ef\u5355\u4e2a\u6b8b\u4f59<\/p>\n<p style=\"line-height: 3em;\">\u25a0\u805a\u67ab\u73af\u6c27\u6811\u8102\uff08Polysulfone resin\uff09\u89c4\u5b9a U.S. FDA CFR 21 177.1655<\/p>\n<p style=\"line-height: 3em;\">\u53bb\u79bb\u5b50\u6c34\u6d78\u53d6\u6cd5\u30013%\u51b0\u918b\u9178\u6d78\u53d6\u6cd5\u300150%\u4e59\u9187\u6d78\u53d6\u6cd5\u3001\u6b63\u5e9a\u70f7\u6d78\u53d6\u6cd5<\/p>\n<p style=\"line-height: 3em;\">\u25a0\u805a\u4e9a\u6c28\u73af\u6c27\u6811\u8102\uff08PU\uff09\u89c4\u5b9a U.S. FDA CFR 21 177.1680<\/p>\n<p style=\"line-height: 3em;\">\u8010\u78e8\u635f\u68c0\u6d4b\u3001\u53bb\u79bb\u5b50\u6c34\u6d78\u53d6\u6cd5\u30018%\u4e59\u9187\u6d78\u53d6\u6cd5<\/p>\n<p style=\"line-height: 3em;\">\u25a0\u4e01\u4e8c\u70ef\u89c4\u5b9a\uff08Styrene block polymer\uff09 U.S. FDA CFR 21177.1810<\/p>\n<p style=\"line-height: 3em;\">\u53bb\u79bb\u5b50\u6c34\u6d78\u53d6\u6cd5\u300150%\u4e59\u9187\u6d41\u56de\u63d0\u7eaf\u3001\u6eb6\u89e3\u6027\u3001\u76f8\u5bf9\u5206\u5b50\u8d28\u91cf\u3001\u73bb\u7483\u5316\u53d8\u5316\u6eab\u5ea6<\/p>\n<p style=\"line-height: 3em;\">\u25a0MMA\u3001MBS\u89c4\u5b9a.. U.S. FDA CFR 21 177.1830<\/p>\n<p style=\"line-height: 3em;\">Non-volatile residue<\/p>\n<p style=\"line-height: 3em;\">KmnO4 oxidized water extractives<\/p>\n<p style=\"line-height: 3em;\">KmnO4 oxidized 8% ethanol extractives<\/p>\n<p style=\"line-height: 3em;\">UV absorbing water extractives<\/p>\n<p style=\"line-height: 3em;\">UV absorbing 8% ethanol extractives<\/p>\n<p style=\"line-height: 3em;\">UV absorbing n-heptane extractives<\/p>\n<p style=\"line-height: 3em;\">\u25a0\u4e09\u805a\u6c30\u80fa\u7532\u919b\u6811\u8102\uff08UF\uff09\u89c4\u5b9a U.S. FDA CFR 21 177.1900<\/p>\n<p style=\"line-height: 3em;\">\u53bb\u79bb\u5b50\u6c34\u6d78\u53d6\u6cd5\u30018%\u4e59\u9187\u6d78\u53d6\u6cd5\u3001\u6b63\u5e9a\u70f7\u6d78\u53d6\u6cd5<\/p>\n<p style=\"line-height: 3em;\">\u25a0PVC\u89c4\u5b9a U.S. FDA CFR 21 175.300<\/p>\n<p style=\"line-height: 3em;\">\u53bb\u79bb\u5b50\u6c34\u6d78\u53d6\u6cd5\u3001\u6b63\u5e9a\u70f7\u6d78\u53d6\u6cd5\u30018%\u4e59\u9187\u6d78\u53d6\u6cd5\u3001VCM\u5355\u4e2a\u6b8b\u4f59<\/p>\n<p style=\"line-height: 3em;\">\u25a0\u805a\u916f\u73af\u6c27\u6811\u8102\uff08Polyester resin\uff09\u89c4\u5b9a U.S. FDA CFR 21 177.2420<\/p>\n<p style=\"line-height: 3em;\">\u4e59\u919a\u53ef\u6eb6\u89e3\u63d0\u7eaf\u7269<\/p>\n<p style=\"line-height: 3em;\">\u25a0\u5851\u80f6\u89c4\u5b9a\uff08SBS,TPR,TPE\uff09\u7845\u80f6\u6750\u6599\u7b49\u5f39\u6027\u4f53\u6750\u6599 U.S. FDA CFR 21 177.2600<\/p>\n<p style=\"line-height: 3em;\">\u53bb\u79bb\u5b50\u6c34\u6d78\u53d6\u6cd5\u3001\u6b63\u5df1\u70f7\u6d78\u53d6\u6cd5(\u53ea\u5bf9\u4e8e\u4eba\u4f53\u8102\u80aa\u7c7b\u98df\u6750\u89e6\u78b0)<\/p>\n<p style=\"line-height: 3em;\">\u25a0\u9540\u91d1\u4ea7\u54c1\u89c4\u5b9a U.S. FDA CPG 7117.05<\/p>\n<p style=\"line-height: 3em;\">\u94c5\u63d0\u7eaf<\/p>\n<p style=\"line-height: 3em;\">\u25a0\u74f7\u5668\u3001\u5939\u5c42\u73bb\u7483\u3001\u5858\u74f7\u5bb9\u5668\u89c4\u5b9a U.S. FDA CPG 7117.06,07<\/p>\n<p style=\"line-height: 3em;\">\u603b\u6df7\u94c5\u3001\u9549\u68c0\u6d4b<\/p>\n<p style=\"line-height: 3em;\">\u25a0\u91d1\u5c5e\u6750\u6599\u89c4\u5b9a U.S. FDA CFR 175.300 &amp; CPG 7117.05<\/p>\n<p style=\"line-height: 3em;\">\u53bb\u79bb\u5b50\u6c34\u6d78\u53d6\u6cd5\u30018%\u4e59\u9187\u6d78\u53d6\u6cd5\u3001\u6b63\u5e9a\u70f7\u6d78\u53d6\u6cd5\u3001\u94c5\u63d0\u7eaf<\/p>\n<p style=\"line-height: 3em;\">\u7167\u660e\u706f\u5177\u89c4\u5b9a<\/p>\n<p style=\"line-height: 3em;\">1968\u5e74\u7f8e\u653f\u5e9c\u516c\u5e03\u4e86Radiation Control for Health and Safety Act\u300a\u63a7\u5236\u8f90\u5c04\u3001\u786e\u4fdd\u5065\u5eb7\u5b89\u5168\u6cd5\u300b\u3002\u8be5\u6cd5\u5f8b\u6cd5\u89c4\u7684\u53d6\u51b3\u4e8e\u7ef4\u62a4\u7fa4\u4f17\u4e0d\u4f1a\u53d7\u5230\u591a\u4f59\u7684\u7535\u5b50\u8bbe\u5907\u8f90\u5c04\u6e90\u635f\u5bb3\u3002\u56e0\u6b64\uff0cFDA\u5236\u8ba2\u4e86\u76f8\u5173\u7535\u5b50\u8bbe\u5907\u8f90\u5c04\u6e90\u7684\u76f8\u5173\u7279\u6027\u89c4\u8303\uff0c\u5f3a\u5236\u6027\u89c4\u5b9a\u8fdb\u5230\u56fd\u5916\u5e02\u573a\u7684\u8f90\u5c04\u5371\u5bb3\u7535\u5b50\u8bbe\u5907\u90fd\u9700\u8981\u5408\u4e4e\u76f8\u5173\u7684\u529f\u80fd\u89c4\u8303\u3002\u7167\u660e\u706f\u5177\u4e2d\u5177\u5907\u8f90\u5c04\u5371\u5bb3\u7684\u592a\u9633\u706f\u3001\u7d2b\u5916\u7ebf\u706d\u83cc\u706f\u548c\u9ad8\u97e7\u6027\u6db2\u6001\u6c34\u94f6\u84b8\u6c14\u653e\u7535\u706f\u5c31\u52a1\u5fc5\u8fbe\u5230FDA\u7684\u89c4\u5b9a\u3002FDA\u5bf9\u8f90\u5c04\u5371\u5bb3\u7167\u660e\u706f\u5177\u7684\u89c4\u5b9a\u5173\u952e\u767e\u5ea6\u6536\u5f55\u5728\u7f8e\u56fd\u8054\u90a6\u6cd5\u89c421 CFR part 1040\u4e2d\u3002<\/p>\n<p style=\"line-height: 3em;\">1. \u5546\u54c1\u8fdb\u53e3\u7684\u7684\u68c0\u6d4b\u7ba1\u63a7\u53ca\u8fdd\u89c4\u884c\u4e3a\u5904\u5206<\/p>\n<p style=\"line-height: 3em;\">\u82f1\u56fd\u5bf9\u8f90\u5c04\u5371\u5bb3\u5546\u54c1\u7684\u8fdb\u53e3\u7684\u68c0\u6d4b\u76d1\u7ba1\u4e5f\u7531\u5176\u82f1\u56fd\u98df\u54c1\u836f\u54c1\u5b89\u5168\u7ba1\u7406\u5904FDA\uff09\u627f\u62c5\u3002FDA\u89c4\u5b9a\u8f90\u5c04\u5371\u5bb3\u5546\u54c1\u7684\u56fd\u5916\u751f\u4ea7\u5382\u5bb6\u5728\u5176\u5546\u54c1\u8fdc\u9500\u82f1\u56fd\u4ee5\u524d,\u5411FDA \u9012\u4ea4\u76f8\u5173\u8981\u6c42\u7684\u539f\u6750\u6599\u3002\u968f\u540e\u7531FDA\u6388\u4e88\u4e00\u4e2a7 \u4f4d\u6570\u636e\u7684\u53f7,\u7b49\u540c\u4e8e\u56fd\u5916\u751f\u4ea7\u5546\u5728FDA\u7684\u5de5\u5546\u6ce8\u518c\u53f7\u3002<\/p>\n<p style=\"line-height: 3em;\">\u91c7\u8d2d\u5546\u5728\u8f90\u5c04\u5371\u5bb3\u5546\u54c1\u8fdb\u53e3\u62a5\u5173\u65f6\u9664\u5411\u6d77\u5173\u7533\u62a5\u4e4b\u5916\uff0c\u8fd8\u52a1\u5fc5\u4ee5FDA 2877\u62a5\u8868(\u7535\u5b50\u8bbe\u5907\u7533\u62a5\u5355) \u5411FDA \u5ba1\u62a5\u3002\u7533\u62a5\u5355\u9664\u5f00\u9700\u6ce8\u660e\u751f\u4ea7\u5382\u5bb6\u3001\u91c7\u8d2d\u5546\u3001\u5546\u54c1\u7b49\u7684\u6709\u5173\u4fe1\u606f\u5185\u5bb9\u5916\uff0c\u8fd8\u5fc5\u987b\u4ee5\u4e0a\u7684\u56fd\u5916\u751f\u4ea7\u5382\u5bb6\u5728FDA\u7684\u5de5\u5546\u6ce8\u518c\u53f7\u3002\u5ba1\u62a5\u6750\u6599\u4e0d\u5168\u6216\u4e0d\u7b26\u5408\u89c4\u5b9a,\u90fd\u7acb\u5373\u88abFDA \u907f\u800c\u4e0d\u89c1\uff0c\u5373\u4f7f\u4e2d\u56fd\u6d77\u5173\u51c6\u8bb8\u6d77\u5173\u653e\u884c\u4e5f\u4e0d\u53ef\u4ee5\u8fdb\u56fd\u5916\u5e02\u573a\u5e02\u573a\u9500\u552e\u3002\u9664\u5f00\u5bf9\u5ba1\u62a5\u6750\u6599\u5b8c\u6210\u5ba1\u6279\u4ee5\u5916\uff0cFDA \u8fd8\u5e94\u5f53\u5728\u5176\u8fdb\u5230\u9500\u552e\u5e02\u573a\u4ee5\u524d\u6216\u4ee5\u540e\u5f00\u5c55\u62bd\u6837\u3001\u68c0\u6d4b,\u4ee5\u67e5\u9a8c\u6b64\u8fdb\u53e3\u5546\u54c1\u662f\u4e0d\u662f\u7684\u786e\u5408\u4e4e\u82f1\u56fd\u76f8\u5173\u653f\u7b56\u6cd5\u89c4\u7684\u5f3a\u5236\u89c4\u5b9a\uff0c\u5bf9\u8fdd\u89c4\u884c\u4e3a\u5546\u54c1FDA \u5c06\u4e25\u82db\u89e3\u51b3\u3002FDA 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3em;\">1994\u5e7410\u670815\u65e5\u524d\u5df2\u5728\u6d77\u5916\u4e0a\u5e02\u7684\u996e\u98df\u642d\u914d\u8425\u517b\u8865\u5145\u5242\u5982\u5e26\u6709\u65b0\u6210\u4efd\uff0c\u4e5f\u5e94\u6309\u4ee5\u4e0a\u89c4\u5b9a\u7533\u8bf7\u529e\u7406\u3002<\/p>\n<p style=\"line-height: 3em;\">FDA\u5728\u63a5\u5230\u901a\u544a\u540e75\u65e5\u5185\u56de\u51fd\uff0c\u544a\u4e4b\u8bc6\u522b\u7801\u5e76\u5b58\u6863\u3002\u82e5\u6709\u8d28\u7591\uff0cFDA\u5219\u5728\u56de\u51fd\u4e2d\u8868\u660e\u539f\u56e0\u3002\u751f\u4ea7\u5382\u5bb6\u6216\u4ee3\u7406\u5546\u5982\u672a\u63a5\u5230FDA \u56de\u51fd\uff0c\u5219\u5e94\u4e0eFDA\u8054\u7edc\uff0c\u638c\u63e1\u76f8\u5173\u72b6\u51b5\u3002\u9488\u5bf9\u65e0\u8bc6\u522b\u7801\u7684\u5546\u54c1\uff0cFDA\u5219\u901a\u544a\u6d77\u5173\u6263\u8d27\u5e76\u56de\u7edd\u8fdb\u53e3\u7684\u3002<\/p>\n<p style=\"line-height: 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