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1982\u5e74\uff0c\u4e2d\u56fd\u9752\u84bf\u7d20\u7c7b\u836f\u7269\u751f\u4ea7\u7684\u836f\u5382\uff0c\u5f00\u59cb\u8fce\u6765\u56fd\u9645\u4e13\u5bb6\u7ec4\u7684\u5b9e\u5730\u8003\u5bdf\uff0c\u5c1d\u8bd5\u8d70\u5411\u56fd\u9645\u3002<\/p>\n

\u56de\u671b\u8fc7\u53bb40\u5e74\uff0c\u4e2d\u56fd\u9752\u84bf\u7d20\u7c7b\u836f\u7269\u7684\u56fd\u9645\u5408\u4f5c\uff0c\u7ecf\u5386\u4e86\u4e0e\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\u3001\u8de8\u56fd\u516c\u53f8\u3001\u56fd\u9645\u7ec4\u7ec7\u7b49\u591a\u79cd\u884c\u4e3a\u4f53\u5408\u4f5c\u7684\u4e0d\u540c\u9636\u6bb5\u3002\u5728\u4e0e\u56fd\u9645\u6807\u51c6\u548c\u5e02\u573a\u89c4\u5219\u4e0d\u65ad\u78b0\u649e\u3001\u5bf9\u63a5\u3001\u878d\u5408\u7684\u8fc7\u7a0b\u4e2d\uff0c\u4e2d\u56fd\u8fdb\u4e00\u6b65\u6df1\u5316\u4e86\u5bf9\u5176\u7406\u89e3\uff0c\u4e0d\u65ad\u63d0\u5347\u81ea\u8eab\u80fd\u529b\u6c34\u5e73\uff0c\u63a5\u53d7\u5e76\u8fdb\u800c\u5f71\u54cd\u56fd\u9645\u6807\u51c6\u548c\u5e02\u573a\u89c4\u5219\u7684\u5236\u5b9a\u3002<\/p>\n

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<\/p>\n

1993\u5e74\u521d\uff0c\u6842\u6797\u836f\u5382\u9752\u84bf\u7425\u916f\u7c7b\u836f\u7269\u8d8a\u5357\u5e02\u573a\u63a8\u5e7f\u56e2\u961f\uff0c\u5de6\u8d77\u4e3a\u6842\u6797\u4e8c\u836f\u5382\u987e\u660e\u626c\u3001\u5c71\u4e1c\u7701\u4e2d\u533b\u836f\u7814\u7a76\u6240\u9b4f\u632f\u5174\u3001\u5468\u514b\u9f0e\u3001\u6842\u6797\u4e8c\u836f\u5382\u5382\u957f\u53f6\u6cbb\u751f\u3001\u5e7f\u5dde\u4e2d\u533b\u5b66\u9662\u674e\u56fd\u6865\u3001\u6842\u6797\u4e00\u836f\u5382\u5218\u65ed\u3001\u4e2d\u4fe1\u6280\u672f\u516c\u53f8\u674e\u5fd7\u65b9\u3002<\/p>\n

\u6765\u6e90\uff5c\u8d5b\u5148\u751f<\/p>\n

\u64b0\u6587\uff5c\u675c\u6da6\u8317\uff0c\u8463\u96ea\u6d01\uff0c\u5bd2\u9732\uff0c\u5218\u5149\u5947\uff0c\u8d39\u77e5\uff0c\u738b\u54f2\u658c<\/p>\n

\u9752\u84bf\u7d20\u884d\u751f\u7269\u5982\u4eca\u662f\u5168\u7403\u6700\u6709\u6548\u3001\u65e0\u5e76\u53d1\u75c7\u6076\u6027\u759f\u75be\u8054\u5408\u7528\u836f\u7684\u5173\u952e\u7ec4\u5206\u4e4b\u4e00\uff0c\u800c\u4e2d\u56fd\u79d1\u5b66\u5bb6\u5c60\u5466\u5466\u4e5f\u56e0\u76f8\u5173\u53d1\u73b0\uff0c\u6210\u4e3a\u4e2d\u56fd\u5185\u5730\u672c\u571f\u57f9\u517b\u51fa\u6765\u7684\u9996\u4f4d\u8bfa\u8d1d\u5c14\u79d1\u5b66\u5956\u9879\u5f97\u4e3b\u3002<\/p>\n

\u4f46\u9c9c\u4e3a\u4eba\u77e5\u7684\u662f\uff0c\u9752\u84bf\u7d20\u7c7b\u6297\u759f\u836f\u5728\u633d\u6551\u6570\u5343\u4e07\u751f\u547d\u4e4b\u524d\uff0c\u4ece1982\u5e74\u5f00\u59cb\uff0c\u66fe\u7ecf\u5386\u8fc7\u4e00\u6bb5\u6ce2\u6298\u7684\u56fd\u9645\u5408\u4f5c\u4e4b\u8def\u3002<\/p>\n

\u9752\u84bf\u7d20\u4f5c\u4e3a\u6297\u759f\u836f\u9996\u6b21\u901a\u8fc7\u56fd\u5185\u4e13\u5bb6\u9274\u5b9a\u662f\u57281978\u5e74\u3002\u5f53\u5e74\uff0c\u4e2d\u56fd\u8fd8\u53d1\u751f\u4e86\u53e6\u5916\u4e24\u4ef6\u5927\u4e8b\uff1a\u6539\u9769\u5f00\u653e\u3001\u540c\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\uff08WHO\uff09\u7b7e\u8ba2\u300a\u536b\u751f\u6280\u672f\u5408\u4f5c\u5907\u5fd8\u5f55\u300b\u3002<\/p>\n

\u4e8e\u662f\uff0c\u9752\u84bf\u7d20\uff0c\u8fd9\u4e2a\u5728\u8d8a\u5357\u6218\u4e89\u80cc\u666f\u4e0b\u4e2d\u7f8e\u53cc\u65b9\u4e3a\u51cf\u8f7b\u759f\u75be\u4f24\u5bb3\u800c\u8fdb\u884c\u7684\u7814\u53d1\u7ade\u4e89\u7684\u6210\u679c\uff0c\u4e5f\u968f\u77401978\u8fd9\u4e00\u9887\u5177\u8c61\u5f81\u610f\u5473\u7684\u5e74\u4efd\uff0c\u5f00\u59cb\u4e86\u8d70\u5411\u56fd\u9645\u7684\u6f2b\u957f\u5f81\u7a0b\u3002\u5728\u6b64\u8fc7\u7a0b\u4e2d\uff0c\u56f4\u7ed5\u4e00\u7cfb\u5217\u56fd\u9645\u6807\u51c6\u7684\u4e89\u8bba\u3001\u59a5\u534f\u3001\u878d\u5408\u4e0e\u534f\u4f5c\uff0c\u6210\u4e3a\u4e2d\u56fd\u4e0e\u4e16\u754c\u4e92\u52a8\u7684\u9c9c\u6d3b\u6ce8\u811a\u3002<\/p>\n

\u51fa\u5e08\u4e0d\u5229\uff0c\u672a\u80fd\u901a\u8fc7WHO\u68c0\u67e5<\/strong><\/p>\n

\u65f6\u95f4\u56de\u523040\u5e74\u524d\u3002<\/p>\n

1982\u5e74\uff0c\u6842\u6797\u7b2c\u4e8c\u5236\u836f\u5382\u9752\u84bf\u7425\u916f\u7c89\u9488\u5242\u8f66\u95f4\uff0c\u6b63\u7b49\u5f85\u63a5\u53d7\u56fd\u9645\u4e13\u5bb6\u7ec4\u7684\u5b9e\u5730\u8003\u5bdf\uff0c\u786e\u8ba4\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff08GMP\uff09\u662f\u5426\u8fbe\u6807\u3002<\/p>\n

\u4e3a\u4e86\u8fd9\u6b21\u610f\u4e49\u91cd\u5927\u7684\u68c0\u67e5\uff0c\u4e2d\u56fd\u65e9\u65e9\u5c31\u62e8\u51fa\u4e13\u6b3e\uff0c\u5bf9\u6842\u6797\u7b2c\u4e8c\u5236\u836f\u5382\u7684\u8f66\u95f4\u8fdb\u884c\u6280\u672f\u6539\u9020\uff0c\u589e\u52a0\u4e86\u51c0\u5316\u548c\u7a7a\u8c03\u8bbe\u5907\uff0c\u8fd8\u6d3e\u51fa\u4e13\u5bb6\u57f9\u8bad\u6280\u672f\u9aa8\u5e72\u3002<\/p>\n

\u56fd\u9645\u4e13\u5bb6\u7ec4\u5230\u6842\u6797\u4e24\u5929\u524d\uff0c\u8be5\u836f\u5382\u5f97\u5230\u901a\u77e5\uff0c\u4e13\u5bb6\u7ec4\u5728\u6606\u660e\u5236\u836f\u5382\u84bf\u7532\u919a\u6ce8\u5c04\u5242\u8f66\u95f4\u7684\u68c0\u67e5\u7ed3\u679c\u5e76\u4e0d\u7406\u60f3\uff0c\u4e0b\u4e00\u7ad9\u5c31\u662f\u6842\u6797\uff0c\u201c\u4e00\u5b9a\u8981\u597d\u597d\u51c6\u5907\u201d \u3002<\/p>\n

\u4e24\u5929\u540e\uff0c\u56fd\u9645\u4e13\u5bb6\u7ec4\u62b5\u8fbe\u6842\u6797\u3002\u4e0e\u9884\u60f3\u4e2d\u53ea\u5ba1\u67e5\u8f66\u95f4\u3001\u8bbe\u5907\u548c\u89c4\u7ae0\u5236\u5ea6\u4e0d\u540c\uff0c\u8fd9\u573a\u68c0\u67e5\u53ef\u8c13\u201c\u770b\u5929\u770b\u5730\u770b\u7a7a\u6c14\u201d\uff0c\u95ee\u9898\u91cd\u91cd\uff1a\u751f\u4ea7\u7a7a\u95f4\u6ca1\u6709\u65e0\u83cc\u68c0\u6d4b\u5de5\u5e8f\u3001\u6d88\u6bd2\u8fc7\u6ee4\u8bbe\u5907\u88c5\u5728\u4e86\u4e0d\u6d88\u6bd2\u7684\u4f4d\u7f6e\u3001\u751f\u4ea7\u8bb0\u5f55\u672c\u4e0a\u6bcf\u6b21\u6dfb\u52a0\u539f\u6599\u7684\u91cf\u4e0d\u4e00\u81f4\u3001\u5316\u9a8c\u5ba4\u7ec6\u83cc\u68c0\u67e5\u65b9\u6cd5\u592a\u8001\u2026\u2026<\/p>\n

\u5728\u65e0\u83cc\u751f\u4ea7\u8f66\u95f4\u7684\u5b9e\u9a8c\u53f0\u4e24\u4fa7\uff0c\u6446\u653e\u7740\u4e00\u6392\u672a\u8d34\u201c\u6d88\u6bd2\u201d\u548c\u201c\u5df2\u7528\u8fc7\u201d\u6807\u7b7e\u7684\u73bb\u7483\u676f\uff0c\u7f8e\u56fd\u836f\u76d1\u5c40\uff08FDA\uff09\u7684\u68c0\u67e5\u5458\u7f57\u7eb3\u5fb7\u00b7\u6cf0\u65af\u62c9\u592b\u8ba9\u5728\u573a\u7684\u4eba\u90fd\u8f6c\u8fc7\u8eab\u53bb\uff0c\u4ece\u5b9e\u9a8c\u53f0\u4e0a\u62ff\u8d77\u4e24\u4e2a\u676f\u5b50\u5411\u5927\u5bb6\u53d1\u95ee\uff1a\u201c\u8c01\u77e5\u9053\u54ea\u4e00\u53ea\u676f\u5b50\u662f\u5e72\u51c0\u6d88\u6bd2\u7684\uff1f\u201d<\/p>\n

\u9762\u5bf9\u8f66\u95f4\u4f17\u4eba\u7684\u6c89\u9ed8\uff0c\u6cf0\u65af\u62c9\u592b\u4e25\u8083\u5730\u8bf4\uff1a\u201c\u8fd9\u5c31\u662fGMP\u3002\u770b\u4f3c\u7b80\u5355\u7684\u4e8b\uff0c\u4f46\u5b9e\u9645\u6267\u884c\u8d77\u6765\u5c31\u4e0d\u7b80\u5355\u4e86\u3002\u201d<\/p>\n

\u6700\u7ec8\uff0c\u4e13\u5bb6\u7ec4\u63d0\u51fa\u4e8622\u6761\u6539\u8fdb\u610f\u89c1\uff0c\u5e76\u7efc\u5408\u5bf9\u591a\u5bb6\u836f\u5382\u68c0\u67e5\u7ed3\u679c\u8ba4\u5b9a\uff0c\u201c\u4e2d\u65b9\u7684\u9752\u84bf\u7425\u916f\u5236\u5242\u751f\u4ea7\u7f3a\u4e4fGMP\u201d [1,2]\u3002<\/p>\n

\u4e2d\u56fd\u533b\u836f\u4ea7\u54c1\u9996\u6b21\u5c1d\u8bd5\u51fa\u6d77\u4fbf\u906d\u9047\u91cd\u5927\u632b\u6298\uff0c\u4ee4\u4e2d\u65b9\u56e2\u961f\u59cb\u6599\u672a\u53ca\u3002<\/p>\n

\u5f53\u65f6\uff0c\u5168\u7403\u759f\u75be\u53cd\u5f39\uff0c\u5728\u4e1c\u5357\u4e9a\u3001\u897f\u592a\u5e73\u6d0b\u3001\u5357\u7f8e\u6d32\u53ca\u4e1c\u975e\u5730\u533a\u6297\u836f\u759f\u539f\u866b\u682a\u8fc5\u901f\u8513\u5ef6\uff0c\u539f\u6709\u7684\u4e00\u4e9b\u6297\u759f\u836f\uff0c\u5982\u6c2f\u55b9\u3001\u4e59\u80fa\u5627\u5576\u7b49\uff0c\u5bf9\u8fd9\u7c7b\u759f\u539f\u866b\u65e0\u6548\uff0c\u52a0\u91cd\u4e86\u759f\u75be\u7684\u9632\u6cbb\u96be\u5ea6\uff0c\u4e9f\u9700\u65b0\u836f\u626d\u8f6c\u5f62\u52bf\u30021980\u5e74\u524d\u540e\uff0c\u4e2d\u56fd\u5305\u62ec\u9752\u84bf\u7d20\u5316\u5b66\u7ed3\u6784\u5728\u5185\u7684\u591a\u7bc7\u9752\u84bf\u7d20\u76f8\u5173\u8bba\u6587\u4e00\u7ecf\u53d1\u8868\uff0c\u4fbf\u5f15\u8d77WHO\u3001\u7f8e\u56fd\u6c83\u5c14\u7279\u00b7\u91cc\u5fb7\u9646\u519b\u7814\u7a76\u6240\uff08WRAIR\uff09\u3001\u82f1\u56fd\u4f26\u6566\u70ed\u5e26\u75c5\u533b\u5b66\u548c\u536b\u751f\u5b66\u9662\u7b49\u673a\u6784\u7684\u9ad8\u5ea6\u6ce8\u610f[3]\u3002\u56e0\u6b64\uff0c\u6297\u759f\u836f\u5f88\u5feb\u6210\u4e3a\u4e2d\u56fd\u548cWHO\u5408\u4f5c\u7684\u5173\u952e\u9886\u57df\u4e4b\u4e00[1]\u3002<\/p>\n

1981\u5e7410\u6708\uff0cWHO\u759f\u75be\u5316\u7597\u79d1\u5b66\u5de5\u4f5c\u7ec4\uff08\u4ee5\u4e0b\u7b80\u79f0WHO\u5de5\u4f5c\u7ec4\uff09\u6765\u5230\u5317\u4eac\uff0c\u9996\u6b21\u5728\u65e5\u5185\u74e6\u603b\u90e8\u4ee5\u5916\u53ec\u5f00\u4f1a\u8bae\uff0c\u5bf9\u9752\u84bf\u7d20\u53ca\u5176\u884d\u751f\u7269\u7684\u6297\u759f\u4f5c\u7528\u7ed9\u4e88\u9ad8\u5ea6\u8bc4\u4ef7\u3002\u6b64\u6b21\u4f1a\u8bae\u540e\uff0c\u4e2d\u65b9\u6b63\u5f0f\u5f00\u59cb\u4e0eWHO\u5408\u4f5c\u8fdb\u884c\u9752\u84bf\u7d20\u7c7b\u836f\u54c1\u5f00\u53d1\u3002<\/p>\n

<\/p>\n

1981\u5e7410\u6708\uff0cWHO\u759f\u75be\u5316\u7597\u79d1\u5b66\u5de5\u4f5c\u7ec4\u7b2c4\u6b21\u4f1a\u8bae\u5728\u5317\u4eac\u53ec\u5f00\u9752\u84bf\u7d20\u4e13\u9898\u5b66\u672f\u8ba8\u8bba\u4f1a\u3002<\/p>\n

\u4e3a\u4e0eWHO\u66f4\u597d\u5f00\u5c55\u5408\u4f5c\uff0c\u4e2d\u56fd\u5f53\u65f6\u7684\u536b\u751f\u90e8\u548c\u56fd\u5bb6\u533b\u836f\u7ba1\u7406\u603b\u5c40\u51b3\u5b9a\u6210\u7acb\u9752\u84bf\u7d20\u53ca\u5176\u884d\u751f\u7269\u7814\u7a76\u6307\u5bfc\u59d4\u5458\u4f1a\uff08\u4ee5\u4e0b\u7b80\u79f0\u9752\u6307\u59d4\uff09\uff0c\u8d1f\u8d23\u4e0eWHO\u534f\u8c03\u8054\u7edc\uff0c\u5e76\u7ec4\u7ec7\u56fd\u5185\u5404\u79d1\u7814\u673a\u6784\u7684\u7814\u7a76\u5de5\u4f5c\uff0c\u7531\u539f\u5168\u56fd523\u9886\u5bfc\u5c0f\u7ec4\u529e\u516c\u5ba4\u8d1f\u8d23\u4eba\u4e4b\u4e00\u7684\u5468\u514b\u9f0e\u62c5\u4efb\u79d8\u4e66\u957f\u3002<\/p>\n

\u5468\u514b\u9f0e\u66fe\u79f0\uff0c\u4e2d\u56fd\u4eba\u539f\u521b\u53d1\u660e\u7684\u65b0\u836f\u5f88\u5c11\uff0c\u4e00\u4e2a\u662f\u9ebb\u9ec4\u7d20\uff0c\u53e6\u4e00\u4e2a\u5c31\u662f\u9752\u84bf\u7d20\uff0c\u201c\u9ebb\u9ec4\u7d20\u662f\u5728\u4e2d\u56fd\u5f00\u82b1\uff0c\u5728\u5916\u56fd\u7ed3\u679c\u201d\uff0c\u4e2d\u56fd\u6210\u4e86\u201c\u6367\u7740\u91d1\u996d\u7897\u6ca1\u996d\u5403\u201d\uff0c\u56e0\u6b64\u201c\u4e00\u5b9a\u8981\u628a\uff08\u9752\u84bf\u7d20\uff09\u63a8\u5411\u4e16\u754c[4]\u3002\u201d<\/p>\n

\u957f\u671f\u5173\u6ce8\u9752\u84bf\u7d20\u7c7b\u836f\u7269\u7814\u53d1\u53f2\u7684\u5317\u4eac\u5927\u5b66\u533b\u5b66\u4eba\u6587\u5b66\u9662\u52a9\u7406\u7814\u7a76\u5458\u9ece\u6da6\u7ea2\u4ecb\u7ecd\uff0c\u9762\u5bf9\u759f\u75be\u8fd9\u4e00\u4e16\u754c\u6027\u96be\u9898\uff0c\u5f53\u65f6\u7684\u8001\u79d1\u5b66\u5bb6\u5341\u5206\u5e0c\u671b\u80fd\u5c06\u4e2d\u56fd\u7814\u5236\u7684\u597d\u836f\u8fd0\u7528\u5230\u5168\u7403\u5e2e\u52a9\u5230\u66f4\u591a\u9700\u8981\u7684\u4eba\u3002\u800c\u5f00\u5c55\u56fd\u9645\u5408\u4f5c\u7684\u8fc7\u7a0b\uff0c\u65e2\u662f\u4e2d\u56fd\u4e86\u89e3\u548c\u5b66\u4e60\u56fd\u9645\u5148\u8fdb\u7684\u836f\u7269\u7814\u53d1\u548c\u7ba1\u7406\u7cfb\u7edf\u7684\u8fc7\u7a0b\uff0c\u4e5f\u662f\u5411\u56fd\u9645\u5c55\u793a\u4e2d\u56fd\u79d1\u7814\u6210\u679c\u7684\u8fc7\u7a0b\uff0c\u201c\u81ea\u7136\u800c\u7136\u4f1a\u6709\u79cd\u81ea\u8c6a\u611f\u3002\u201d<\/p>\n

\u968f\u7740\u5408\u4f5c\u987a\u5229\u63a8\u8fdb\uff0c1982\u5e742\u6708\uff0cWHO\u5de5\u4f5c\u7ec4\u6d3e\u4e13\u5bb6\u8bbf\u534e\uff0c\u53c2\u89c2\u591a\u5bb6\u79d1\u7814\u5355\u4f4d\u548c\u6842\u6797\u7b2c\u4e8c\u5236\u836f\u5382\u540e\uff0c\u4e0e\u4e2d\u65b9\u521d\u6b65\u8fbe\u6210\u5408\u4f5c\u534f\u8bae\uff0c\u8ba1\u5212\u5728\u4e24\u5e74\u5185\u6309\u56fd\u9645\u6807\u51c6\u5b8c\u6210\u9752\u84bf\u7d20\uff08\u53e3\u670d\uff09\u3001\u84bf\u7532\u919a\uff08\u6ce8\u5c04\u5242\uff09\u548c\u9752\u84bf\u7425\u916f\uff08\u9488\u5242\uff09\u7684\u4e34\u5e8a\u524d\u7814\u7a76\u8ba1\u5212\uff0c\u4e3a\u540e\u7eed\u56fd\u5916\u4e34\u5e8a\u548c\u65b0\u836f\u56fd\u9645\u6ce8\u518c\u505a\u51c6\u5907\u3002\u5f88\u5feb\uff0cWHO\u5de5\u4f5c\u7ec4\u5c06\u9752\u84bf\u7425\u916f\u4f5c\u4e3a\u6cbb\u7597\u8111\u578b\u759f\u7684\u4f18\u5148\u5f00\u53d1\u9879\u76ee\uff0c\u8003\u8651\u5230\u4e2d\u56fd\u6709\u4e9b\u6761\u4ef6\u5c1a\u4e0d\u5b8c\u5584\uff0c\u63d0\u51fa\u5c06\u59d4\u6d3e\u7f8e\u56fdFDA\u68c0\u67e5\u4eba\u5458\u8bbf\u534e\uff0c\u8fdb\u4e00\u6b65\u4e86\u89e3\u836f\u5382\u751f\u4ea7\u4e0e\u7ba1\u7406\u60c5\u51b5\u3002<\/p>\n

\u6309\u7167\u56fd\u9645\u60ef\u4f8b\uff0c\u65b0\u836f\u5728\u56fd\u5916\u6ce8\u518c\u524d\u5fc5\u987b\u8fdb\u884cGMP\u68c0\u67e5\uff0c\u7531\u4e00\u4e2a\u516c\u8ba4\u6cd5\u5b9a\u673a\u6784\u6d3e\u5458\u5bf9\u751f\u4ea7\u5382\u7684\u751f\u4ea7\u6761\u4ef6\u548c\u7ba1\u7406\u8fdb\u884c\u5b9e\u5730\u8003\u5bdf\u5e76\u505a\u51fa\u5ba1\u8bc4\u3002\u5728\u6b64\u80cc\u666f\u4e0b\uff0c\u624d\u6709\u4e86\u524d\u8ff0\u8003\u5bdf\u3002<\/p>\n

\u8003\u5bdf\u4e2d\uff0c\u56fd\u9645\u4e13\u5bb6\u7ec4\u5148\u540e\u5230\u8bbf\u6606\u660e\u5236\u836f\u5382\u3001\u6842\u6797\u7b2c\u4e00\u5236\u836f\u5382\u3001\u6842\u6797\u7b2c\u4e8c\u5236\u836f\u5382\uff0c\u8fd8\u8bbf\u95ee\u4e86\u5f53\u65f6\u56fd\u5185\u6761\u4ef6\u6700\u597d\u7684\u4e0a\u6d77\u4fe1\u8c0a\u5236\u836f\u5382\uff0c\u4ee5\u5728\u4e2d\u56fd\u7269\u8272\u4e00\u4e2a\u7b26\u5408GMP\u8981\u6c42\u7684\u4f01\u4e1a\u751f\u4ea7\u9752\u84bf\u7425\u916f\u9488\u5242\uff0c\u5c3d\u5feb\u4f9b\u56fd\u5916\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/p>\n

<\/p>\n

1982\u5e749\u6708\uff0c\u7f8e\u56fdFDA\u68c0\u67e5\u5458Tetzlaff\uff08\u53f3\u4e8c\uff09\u5728\u738b\u5927\u6797\u3001\u674e\u6cfd\u7433\u548c\u5468\u514b\u9f0e\uff08\u4ece\u5de6\u81f3\u53f3\uff09\u966a\u540c\u4e0b\u5bf9\u6606\u660e\u3001\u6842\u6797\u5236\u836f\u5382\u8fdb\u884cGMP\u6761\u4ef6\u68c0\u67e5\u3002<\/p>\n

\u9057\u61be\u7684\u662f\uff0c\u4e0a\u8ff0\u8f66\u95f4\u5747\u672a\u901a\u8fc7GMP\u68c0\u67e5\u3002\u8fd9\u610f\u5473\u7740\uff0c\u4e2d\u56fd\u751f\u4ea7\u7684\u836f\u54c1\u4e0d\u80fd\u8fdb\u884c\u56fd\u9645\u8ba4\u53ef\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u9752\u6307\u59d4\u62c5\u5fe7\u4e0eWHO\u8fbe\u6210\u7684\u5408\u4f5c\u5185\u5bb9\u8981\u5168\u90e8\u91cd\u6765\uff0c\u751a\u81f3\u6709\u53ef\u80fd\u5c31\u6b64\u7ec8\u6b62[5]\u3002<\/p>\n

\u4e0e\u6614\u65e5\u5bf9\u624b\u5408\u4f5c\u672a\u679c<\/strong><\/p>\n

\u4e2d\u56fd\u53d1\u73b0\u7684\u9752\u84bf\u7d20\u4ee5\u53ca\u540e\u6765\u53d1\u660e\u7684\u9752\u84bf\u7d20\u7c7b\u836f\u7269\uff0c\u4e3a\u4f55\u4e00\u5b9a\u8981\u901a\u8fc7GMP\u68c0\u67e5\u624d\u80fd\u83b7\u5f97\u56fd\u9645\u8ba4\u53ef\uff1f\u53c8\u4e3a\u4f55\u8981\u4e0eWHO\u5408\u4f5c\u624d\u80fd\u201c\u5e2e\u52a9\u4e2d\u56fd\u8fdb\u4e00\u6b65\u53d1\u5c55\u8fd9\u7c7b\u65b0\u836f\u201d\uff1f<\/p>\n

\u8fd9\u8981\u4ece\u65b0\u836f\u5f00\u53d1\u7a0b\u5e8f\u548c\u836f\u7269\u56fd\u9645\u63a8\u5e7f\u7684\u60ef\u4f8b\u8bf4\u8d77\u3002<\/p>\n

\u9ece\u6da6\u7ea2\u4ecb\u7ecd\uff0c\u65f6\u503c\u6539\u9769\u5f00\u653e\u521d\u671f\uff0c\u4e2d\u56fd\u5bf9\u56fd\u9645\u79d1\u7814\u5408\u4f5c\u7684\u89c4\u5219\u8fd8\u5341\u5206\u964c\u751f\uff0c\u56fd\u5185\u5916\u5bf9\u201c\u65b0\u836f\u201d\u7684\u7406\u89e3\u4e5f\u4e0d\u5bf9\u7b49\u3002<\/p>\n

1985\u5e74\u300a\u65b0\u836f\u5ba1\u6279\u529e\u6cd5\u300b\u9881\u5e03\u524d\uff0c\u56fd\u5185\u6240\u6709\u836f\u7269\u751f\u4ea7\u524d\u5747\u7531\u7814\u53d1\u5355\u4f4d\u7ec4\u7ec7\u4e13\u4e1a\u4eba\u5458\u8fdb\u884c\u6280\u672f\u9274\u5b9a\uff0c\u901a\u8fc7\u540e\u5373\u5c5e\u201c\u65b0\u836f\u201d\uff0c\u53ef\u81ea\u884c\u5b89\u6392\u751f\u4ea7\u4e0a\u5e02\uff0c\u9752\u84bf\u7d20\u5c31\u5c5e\u6b64\u7c7b\u3002\u4f46\u4ece\u56fd\u9645\u836f\u54c1\u5f00\u53d1\u7684\u7a0b\u5e8f\u6765\u770b\uff0c\u5c3d\u7ba1\u56fd\u5185\u5bf9\u9752\u84bf\u7d20\u7ed3\u6784\u3001\u6297\u759f\u6548\u679c\u7b49\u65e9\u6709\u7814\u7a76\uff0c\u4e5f\u5b8c\u6210\u6570\u5343\u4f8b\u4e34\u5e8a\u9a8c\u8bc1\uff0c\u4f46\u5e76\u6ca1\u6709\u4e00\u4e2a\u6743\u5a01\u7684\u65b0\u836f\u5ba1\u6279\u673a\u6784\u548c\u76f8\u5173\u6cd5\u89c4\u5bf9\u836f\u7269\u4ece\u5b9e\u9a8c\u5ba4\u57fa\u7840\u7814\u7a76\u5230\u4e34\u5e8a\u8bd5\u9a8c\u8fdb\u884c\u4e25\u683c\u89c4\u8303\u5ba1\u6279\uff0c\u5bf9\u836f\u7269\u6ce8\u518c\u3001\u4e13\u5229\u3001\u7814\u7a76\u5de5\u4f5c\u7684\u6807\u51c6\u5316\u7b49\u4e8b\u5b9c\u4e5f\u53ef\u8c13\u4e00\u65e0\u6240\u77e5\uff0c\u4e0e\u56fd\u9645\u89c4\u8303\u6709\u5f88\u5927\u5dee\u8ddd\u3002<\/p>\n

\u5c24\u5176\u5728\u836f\u54c1\u751f\u4ea7\u7ba1\u7406\u65b9\u9762\uff0c\u4e3a\u6700\u5927\u7a0b\u5ea6\u4fdd\u8bc1\u836f\u54c1\u8d28\u91cf\u5747\u4e00\u3001\u5b89\u5168\u3001\u6709\u6548\uff0cGMP\u7ecfWHO\u63a8\u8350\u540e\uff0c\u5df2\u9010\u6e10\u6210\u4e3a\u4e00\u9879\u56fd\u9645\u60ef\u4f8b\uff0c\u4e3a\u4e16\u754c\u4e0a\u5927\u591a\u6570\u56fd\u5bb6\u6240\u91c7\u7528\uff0c\u5e76\u6210\u4e3a\u836f\u54c1\u4e0a\u5e02\u548c\u5728\u5176\u4ed6\u56fd\u5bb6\u6ce8\u518c\u9500\u552e\u7684\u5148\u51b3\u6761\u4ef6\uff1a\u4e00\u4e2a\u4f01\u4e1a\u6240\u751f\u4ea7\u7684\u836f\u54c1\u5fc5\u987b\u53d6\u5f97\u8fdb\u53e3\u56fd\u653f\u5e9c\u7684GMP\u68c0\u67e5\u8ba4\u8bc1\u3002<\/p>\n

\u800c\u5728\u5f53\u65f6\uff0c\u56fd\u5185\u8fd8\u6ca1\u6709GMP\u8fd9\u4e00\u6982\u5ff5\uff0c\u5f80\u5f80\u7528\u201c\u4e60\u60ef\u201d\u6216\u201c\u7ecf\u9a8c\u201d\u4ee3\u66ff\u79d1\u5b66\u548c\u89c4\u7ae0\u5236\u5ea6\u3002\u56fd\u9645\u4e13\u5bb6\u7ec4\u7684GMP\u68c0\u67e5\u8ba9\u4e2d\u65b9\u7b2c\u4e00\u6b21\u8ba4\u8bc6\u5230\uff0c\u5b66\u4e60\u3001\u6267\u884c\u548c\u68c0\u67e5GMP\u4e0d\u518d\u662f\u4e00\u53e5\u7a7a\u8bdd\u3002\u53c2\u4e0e\u5f53\u5e74\u73b0\u573a\u68c0\u67e5\u7684\u674e\u6cfd\u7433\u56de\u5fc6\u79f0\uff1a\u201c\u6574\u4e2a\u8fc7\u7a0b\u6211\u4eec\u771f\u662f\u5b66\u5230\u5f88\u591a\u4e1c\u897f\uff0c\u5bf9\u6211\u4eec\u7684\u6559\u80b2\u5f88\u5927[2]\u3002\u201d\u5728\u6b64\u80cc\u666f\u4e0b\uff0c\u4e2d\u56fd\u53ea\u80fd\u4f9d\u9760\u56fd\u9645\u534f\u4f5c\uff0c\u542c\u4ece\u56fd\u9645\u4e13\u5bb6\u6307\u5bfc\u3002<\/p>\n

\u4e8e\u662f\uff0c\u5c3d\u5feb\u63d0\u5347GMP\u6c34\u5e73\u6210\u4e3a\u5f53\u52a1\u4e4b\u6025\u30021982\u5e74\uff0c\u9752\u6307\u59d4\u5411WHO\u5de5\u4f5c\u7ec4\u63d0\u51fa\uff0c\u8ba1\u5212\u5728\u534e\u7b79\u5efaGMP\u8f66\u95f4\uff0c\u540c\u65f6\u5e0c\u671b\u5bf9\u65b9\u534f\u52a9\u8054\u7cfb\u56fd\u5916\u5408\u9002\u7684\u7814\u7a76\u673a\u6784\u534f\u4f5c\u3002\u7f8e\u56fd\u6c83\u5c14\u7279\u00b7\u91cc\u5fb7\u9646\u519b\u7814\u7a76\u6240\uff08WRAIR) \u88ab\u63a8\u8350\u4f5c\u4e3a\u5408\u4f5c\u65b9\u3002\u8fd9\u4e00\u63a8\u8350\u8ba9\u4e2d\u65b9\u56e2\u961f\u9887\u611f\u610f\u5916\uff0c\u5f53\u65f6\u7684\u4e2d\u7f8e\u5173\u7cfb\u751a\u81f3\u4e00\u5ea6\u9762\u4e34\u56fd\u5185\u6ca1\u6709\u90e8\u95e8\u613f\u610f\u5c31\u6b64\u6b21\u5408\u4f5c\u7275\u5934\u8d1f\u8d23\u3002<\/p>\n

\u4f5c\u4e3a\u5728\u4e2d\u56fd\u4ee5\u5916\u8fdb\u884c\u9752\u84bf\u7d20\u751f\u4ea7\u7814\u7a76\u7684\u4e3b\u8981\u673a\u6784\u4e4b\u4e00\uff0cWRAIR\u65e9\u5728\u8d8a\u6218\u65f6\u671f\uff0c\u5c31\u6295\u5165\u5927\u91cf\u4eba\u529b\u8d22\u529b\uff0c\u8054\u5408\u591a\u56fd\u7814\u7a76\u673a\u6784\u548c\u836f\u5382\u5f00\u5c55\u6297\u759f\u75be\u65b0\u836f\u7814\u7a76\u30021964\u5e74\uff0c\u8d8a\u5357\u6218\u4e89\u7206\u53d1\u3002\u5f53\u65f6\u8d8a\u5357\u5e38\u5e74\u6076\u6027\u759f\u75be\u6d41\u884c\uff0c\u7f8e\u56fd\u548c\u8d8a\u5357\u519b\u961f\u90fd\u56e0\u4e3a\u759f\u75be\u9020\u6210\u5927\u91cf\u975e\u6218\u6597\u4f24\u4ea1\u3002\u80fd\u5426\u62b5\u6297\u759f\u75be\uff0c\u751a\u81f3\u6210\u4e86\u8d8a\u5357\u6218\u573a\u4e0a\u7f8e\u8d8a\u53cc\u65b9\u51b3\u5b9a\u80dc\u8d1f\u7684\u5173\u952e\u3002\u5f53\u65f6\u7684\u8d8a\u5171\u603b\u4e66\u8bb0\u80e1\u5fd7\u660e\u4eb2\u81ea\u5230\u5317\u4eac\uff0c\u5411\u6bdb\u6cfd\u4e1c\u63d0\u51fa\u8bf7\u4e2d\u56fd\u652f\u63f4\u6297\u759f\u75be\u836f\u7269\u548c\u65b9\u6cd5\u3002\u5c60\u5466\u5466\u540e\u6765\u53c2\u4e0e\u7684\u201c523\u201d\u9879\u76ee\u7531\u6b64\u542f\u52a8[1]\u3002<\/p>\n

\u4e2d\u7f8e\u53cc\u65b9\u90fd\u5728\u52a0\u7d27\u5bfb\u627e\u5bf9\u6297\u6076\u6027\u759f\u75be\u7684\u65b0\u836f\u3002WRAIR\u4ec51972\u5e74\u5c31\u521d\u7b5b21.4\u4e07\u79cd\u5316\u5408\u7269\uff0c\u4f46\u4e8b\u5b9e\u8bc1\u660e\uff0c\u5176\u7814\u5236\u836f\u7269\u7684\u6548\u679c\u5747\u4e0d\u53ca\u9752\u84bf\u7d20\u7c7b\u836f\u7269\u3002<\/p>\n

1982\u5e74\uff0c\u867d\u7136\u8d8a\u6218\u65e9\u5df2\u7ed3\u675f\uff0c\u4f46\u5728\u5f53\u65f6\u7684\u56fd\u5185\u5916\u5c40\u52bf\u4e0b\uff0c\u9009\u62e9\u4e0e\u6614\u65e5\u201c\u6218\u573a\u4e0a\u7684\u5bf9\u624b\u201d\u8fdb\u884c\u5408\u4f5c\uff0c\u65e0\u7591\u56f0\u96be\u91cd\u91cd\u3001\u987e\u8651\u6df1\u91cd\u3002\u9ece\u6da6\u7ea2\u4ecb\u7ecd\uff0c\u5468\u514b\u9f0e\u5bf9\u6b64\u8d77\u5230\u5173\u952e\u4f5c\u7528\uff0c\u201c\u4ed6\u4eec\u82b1\u4e86\u5f88\u957f\u7684\u65f6\u95f4\uff0c\u53cd\u590d\u6c47\u62a5\u8bf4\u660e\u5408\u4f5c\u7684\u91cd\u8981\u6027\u201d\uff0c\u624d\u63a8\u52a8\u4e86\u4e2d\u56fd\u3001\u7f8e\u56fd\u548cWHO\u7684\u4e09\u65b9\u5408\u4f5c\u3002<\/p>\n

1983\u5e7412\u6708\uff0c\u7b49\u5f85\u534a\u5e74\u540e\uff0c\u9752\u6307\u59d4\u6536\u5230\u7f8e\u65b9\u548cWHO\u6709\u5173\u9752\u84bf\u7425\u916f\u7814\u7a76\u7684\u5408\u4f5c\u534f\u8bae\u4e66\u3002\u4e2d\u65b9\u5185\u90e8\u8ba8\u8bba\u8ba4\u4e3a\uff0c\u534f\u8bae\u6761\u6b3e\u5e76\u672a\u5efa\u7acb\u5728\u5e73\u7b49\u4e92\u5229\u548c\u53cb\u597d\u5408\u4f5c\u7684\u57fa\u7840\u4e0a\uff0c\u800c\u662f\u201c\u4e3b\u6b21\u98a0\u5012\uff0c\u53d6\u800c\u4ee3\u4e4b\uff1b\u6761\u4ef6\u82db\u523b\uff0c\u55a7\u5bbe\u593a\u4e3b\uff1b\u6df7\u6dc6\u53d1\u660e\uff0c\u4f01\u56fe\u83b7\u5229\u201d\uff0c\u751a\u81f3\u8ba4\u4e3aWHO\u4e0e\u7f8e\u56fd\u9632\u90e8\u4e32\u901a\u4e00\u6c14\uff0c\u4f01\u56fe\u4ee5\u201c\u6cd5\u6761\u201d\u628a\u6211\u65b9\u624b\u811a\u6346\u4f4f[6]\u3002<\/p>\n

\u5982\u4eca\u5df2\u5f88\u96be\u901a\u8fc7\u516c\u5f00\u8d44\u6599\uff0c\u63a2\u7a76\u7a76\u7adf\u54ea\u4e9b\u6761\u6b3e\u8ba9\u4e2d\u65b9\u4ea7\u751f\u5982\u6b64\u6fc0\u70c8\u7684\u6307\u63a7\u3002\u9ece\u6da6\u7ea2\u63a8\u6d4b\uff0c\u8fd9\u6216\u4e0e\u53d7\u5f53\u65f6\u4e2d\u7f8e\u5173\u7cfb\u4ee5\u53ca\u5bf9\u56fd\u5916\u533b\u836f\u79d1\u6280\u3001\u77e5\u8bc6\u4ea7\u6743\u53d1\u5c55\u4e0d\u4e86\u89e3\u6709\u5173\uff0c\u201c\u672c\u6765\u2018523\u2019\u662f\u4e3a\u4e86\u6297\u7f8e\u63f4\u8d8a\uff0c\u7f8e\u56fd\u5728\u4e0e\u6211\u4eec\u7ade\u4e89\u7684\u65f6\u5019\u6ca1\u6709\uff08\u628a\u6297\u759f\u836f\uff09\u505a\u51fa\u6765\uff0c\u6211\u4eec\u505a\u51fa\u6765\u4e86\u53c8\u8981\u628a\u6210\u679c\u7ed9\u7f8e\u65b9\u5f00\u53d1\u201d\uff0c\u4e3b\u7ba1\u90e8\u95e8\u4eba\u5458\u4ee5\u53ca\u4e00\u4e9b\u79d1\u7814\u5de5\u4f5c\u8005\u7684\u8fd9\u4e9b\u601d\u6f6e\u4e5f\u5bf9\u5408\u4f5c\u4ea7\u751f\u5f71\u54cd\u3002<\/p>\n

\u6b64\u540e\uff0c\u51fa\u4e8e\u5916\u4ea4\u548c\u653f\u6cbb\u65b9\u9762\u7684\u8003\u91cf\uff0c\u4e2d\u3001\u7f8e\u3001WHO\u4e09\u65b9\u5bf9\u534f\u8bae\u4e66\u4e2d\u591a\u9879\u6761\u6b3e\u7684\u4fee\u6539\u610f\u89c1\u4e0d\u4e00\uff0c\u5bf9\u5404\u65b9\u6743\u5229\u548c\u4e49\u52a1\u7684\u4e89\u8bae\u4e0d\u65ad\uff0c\u52a0\u4e4b\u6c9f\u901a\u4e0d\u7545\uff0c\u6bcf\u6b21\u6761\u6b3e\u4fee\u8ba2\u957f\u8fbe\u8fd1\u534a\u5e74\uff0c\u5408\u4f5c\u8fdb\u5c55\u7f13\u6162\u3002<\/p>\n

\u76f4\u81f31985\u5e74\u4e0b\u534a\u5e74\uff0c\u4e2d\u56fd\u5df2\u57fa\u672c\u540c\u610fWHO\u7684\u4fee\u8ba2\u610f\u89c1\uff0c\u4f46WHO\u5374\u6765\u51fd\u79f0\uff0c\u201c\u4e00\u4f4d\u4e2d\u56fd\u79d1\u5b66\u5bb6\u5728\u7f8e\u56fd\u56fd\u7acb\u536b\u751f\u9662\u90a6\u7f57\u897f\u535a\u58eb\uff08Arnold R. Brossi\uff09\u5b9e\u9a8c\u5ba4\u53d1\u73b0\u9752\u84bf\u7425\u916f\u5728\u67d0\u4e9b\u6761\u4ef6\u4e0b\u4e0d\u7a33\u5b9a\u201d\uff0c\u51b3\u5b9a\u653e\u5f03\u5f00\u53d1\u9752\u84bf\u7425\u916f\uff0c\u8fd9\u573a\u6301\u7eed\u4e09\u5e74\u7684\u4e09\u65b9\u5408\u4f5c\u65e0\u75be\u800c\u7ec8[5]\u3002<\/p>\n

\u5728\u6b64\u671f\u95f4\uff0c\u7f8e\u56fdWRAIR\u4e8e1984\u5e74\u4ece\u7f8e\u56fd\u672c\u571f\u7684\u82b1\u9ec4\u84bf\u690d\u7269\u4e2d\u63d0\u53d6\u51fa\u4e86\u9752\u84bf\u7d20\uff0c1985\u5e74\uff0cScience\u6742\u5fd7\u53d1\u8868WRAIR\u7814\u7a76\u4eba\u5458\u7684\u7efc\u8ff0\u6587\u7ae0\u80af\u5b9a\u9752\u84bf\u7d20\u7684\u529f\u6548\uff0c\u800c\u6700\u7ec8WHO\u4ee5\u9752\u84bf\u7425\u916f\u4e0d\u7a33\u5b9a\u4e3a\u7531\u653e\u5f03\u4e86\u4e0e\u4e2d\u56fd\u7684\u5408\u4f5c\u7814\u53d1[7]\u3002<\/p>\n

<\/p>\n

1984\u5e74\uff0cWHO\u5728\u5317\u4eac\u4e3e\u529e\u7684\u4f53\u6db2\u836f\u7269\u6d53\u5ea6\u6d4b\u5b9a\u5b66\u4e60\u73ed\u3002<\/p>\n

\u76f4\u63a5\u51fa\u53e3\uff0c\u518d\u906d\u78b0\u58c1<\/strong><\/p>\n

\u5728\u4e0eWHO\u53ca\u7f8e\u56fd\u7684\u5408\u4f5c\u76f8\u7ee7\u53d7\u632b\u4e4b\u540e\uff0c\u4e2d\u65b9\u56e2\u961f\u575a\u5b9a\u4e86\u201c\u81ea\u529b\u66f4\u751f\uff0c\u4ee5\u6211\u4e3a\u4e3b\uff0c\u4e24\u6761\u817f\u8d70\u8def\u201d\u7684\u65b9\u9488\uff0c\u4e00\u9762\u52aa\u529b\u586b\u8865\u65b0\u836f\u7814\u53d1\u548c\u5efa\u8bbeGMP\u8f66\u95f4\u7b49\u9886\u57df\u7684\u7a7a\u767d\uff0c\u53e6\u4e00\u65b9\u5f00\u59cb\u5c1d\u8bd5\u76f4\u63a5\u5e26\u836f\u53bb\u56fd\u5916\u505a\u4e34\u5e8a\u7814\u7a76\uff0c\u8bd5\u56fe\u901a\u8fc7\u6d77\u5916\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6548\u679c\u6269\u5927\u56fd\u9645\u5f71\u54cd\uff0c\u4ece\u800c\u5c06\u9752\u84bf\u7d20\u7c7b\u836f\u7269\u63a8\u5411\u56fd\u9645\u5e02\u573a\u3002<\/p>\n

\u5f53\u65f6\uff0c\u8001\u79d1\u5b66\u5bb6\u4eec\u666e\u904d\u76f8\u4fe1\uff0c\u53ea\u8981\u836f\u54c1\u8d28\u91cf\u8fc7\u786c\uff0c\u56fd\u9645\u79d1\u5b66\u754c\u80fd\u770b\u5230\u5176\u6548\u679c\u4e0e\u5f71\u54cd\uff0c\u9752\u84bf\u7d20\u7c7b\u836f\u7269\u4e0d\u53ef\u80fd\u8d70\u4e0d\u51fa\u56fd\u95e8\u3002<\/p>\n

1987\u5e74\uff0c\u519b\u4e8b\u533b\u5b66\u79d1\u5b66\u9662\u6559\u6388\u7126\u5cab\u537f\u7b49\u4eba\u5728\u5c3c\u65e5\u5229\u4e9a\u5f00\u5c55\u84bf\u7532\u919a\u7684\u4e34\u5e8a\u7814\u7a76\uff0c\u53d1\u73b0\u5176\u7597\u6548\u7b49\u591a\u65b9\u9762\u5747\u4f18\u4e8e\u6c2f\u55b9\u3002\u8fd9\u4e00\u7ed3\u679c\u88ab\u5f53\u5730\u5a92\u4f53\u62a5\u9053\uff0c\u79f0\u84bf\u7532\u919a\u662f\u201c\u795e\u836f\u201d\u201c\u7075\u4e39\u5999\u836f\u201d\u3002\u4f46\u7b2c\u4e8c\u5929\uff0c\u5f53\u5730\u7684\u53e6\u4e00\u5bb6\u62a5\u7eb8\u8bc4\u8bba\u79f0\uff0c\u4e2d\u56fd\u7684\u6297\u759f\u836f\u867d\u597d\uff0c\u4f46\u5b9e\u9a8c\u5ba4\u7814\u7a76\u4e0d\u7b26\u5408GLP\uff08\u826f\u597d\u5b9e\u9a8c\u5ba4\u7ba1\u7406\u89c4\u8303\uff09\u3001\u4e34\u5e8a\u7814\u7a76\u4e0d\u7b26\u5408GCP\uff08\u4e34\u5e8a\u8bd5\u9a8c\u89c4\u8303\u6807\u51c6\uff09\u3001\u751f\u4ea7\u6761\u4ef6\u4e0d\u7b26\u5408GMP\u3002\u4e2d\u56fd\u6297\u759f\u836f\u51fa\u6d77\u518d\u6b21\u5931\u8d25[8]\u3002<\/p>\n

1988\u5e745\u670824\u65e5\uff0c\u56fd\u5bb6\u79d1\u59d4\u4e3b\u6301\u53ec\u5f00\u201c\u5173\u4e8e\u63a8\u5e7f\u548c\u5f00\u53d1\u9752\u84bf\u7d20\u7c7b\u6297\u759f\u836f\u56fd\u9645\u5e02\u573a\u201d\u7684\u5ea7\u8c08\u4f1a\u4e0a\uff0c\u5468\u514b\u9f0e\u518d\u6b21\u6307\u51fa\u4e2d\u56fd\u836f\u54c1\u5728\u7814\u7a76\u548c\u751f\u4ea7\u4e0a\u4e0e\u56fd\u9645\u6807\u51c6\u5b58\u5728\u5dee\u8ddd\uff0c\u5fc5\u987b\u4f9d\u9760\u56fd\u5bb6\u653f\u7b56\uff0c\u501f\u52a9\u5916\u8d38\u516c\u53f8\u7684\u529b\u91cf\u8d70\u4e0e\u56fd\u9645\u5927\u516c\u53f8\u8054\u5408\u7684\u9053\u8def\uff0c\u8fd9\u4e00\u89c2\u70b9\u5f97\u5230\u4e0e\u4f1a\u8005\u4e00\u81f4\u8ba4\u53ef[8]\u3002<\/p>\n

<\/p>\n

1988\u5e74\uff0c\u519b\u4e8b\u533b\u5b66\u79d1\u5b66\u9662\u7126\u5cab\u537f\uff08\u53f3\u4e00\uff09\u4e0e\u4e13\u5bb6\u7ec4\u5728\u5c3c\u65e5\u5229\u4e9a\u8fdb\u884c\u84bf\u7532\u919a\u4e34\u5e8a\u9a8c\u8bc1\u8bd5\u9a8c\u3002<\/p>\n

\u7531\u4e8e\u4e0eWHO\u7684\u9752\u84bf\u7d20\u5408\u4f5c\u5df2\u7ecf\u7ec8\u6b62\uff0c\u540c\u5e746\u6708\uff0c\u5b8c\u6210\u4e86\u4f7f\u547d\u7684\u9752\u6307\u59d4\u6b63\u5f0f\u64a4\u9500\uff0c\u9752\u84bf\u7d20\u7c7b\u836f\u7269\u7684\u7814\u53d1\u5de5\u4f5c\u7eb3\u5165\u519b\u79d1\u9662\u3001\u79d1\u5b66\u9662\u548c\u536b\u751f\u90e8\u7b49\u7814\u53d1\u5355\u4f4d\u6240\u5c5e\u653f\u5e9c\u90e8\u95e8\u7ba1\u7406\uff0c\u56fd\u9645\u5e02\u573a\u5f00\u62d3\u7684\u7ec4\u7ec7\u4e0e\u534f\u8c03\u5de5\u4f5c\u5219\u7531\u56fd\u5bb6\u79d1\u59d4\u62c5\u5f53\u3002<\/p>\n

\u4e00\u5e74\u540e\uff0c\u8d1f\u8d23\u627f\u62c5\u9752\u84bf\u7d20\u7c7b\u6297\u759f\u836f\u56fd\u9645\u5e02\u573a\u5f00\u62d3\u7684\u5355\u4f4d\u7ade\u6807\u5de5\u4f5c\u542f\u52a8\uff0c\u62e5\u6709\u56fd\u5bb6\u6388\u4e88\u5916\u8d38\u6743\u7684\u4e2d\u56fd\u56fd\u9645\u4fe1\u6258\u6295\u8d44\u516c\u53f8\u6240\u5c5e\u7684\u4e2d\u4fe1\u6280\u672f\u516c\u53f8\uff08\u4ee5\u4e0b\u7b80\u79f0\u4e2d\u4fe1\u516c\u53f8\uff09\u6210\u4e3a\u5341\u51e0\u5bb6\u4e2d\u6807\u5355\u4f4d\u4e4b\u4e00\u3002<\/p>\n

\u4f5c\u4e3a\u56fd\u5bb6\u6539\u9769\u5f00\u653e\u7684\u7a97\u53e3\uff0c\u4e2d\u4fe1\u516c\u53f8\u662f\u5f53\u65f6\u56fd\u5185\u5c11\u6570\u62e5\u6709\u5916\u8d38\u6743\u3001\u80fd\u5c06\u56fd\u5185\u4ea7\u54c1\u5411\u6d77\u5916\u51fa\u53e3\u7684\u516c\u53f8\uff0c\u66fe\u57281980\u5e74\u4ee3\u5728\u56fd\u5185\u6295\u8d44\u4e86\u5927\u91cf\u5b9e\u4e1a\u8d38\u6613\u9879\u76ee\uff0c\u800c\u9752\u84bf\u7d20\u7c7b\u6297\u759f\u836f\u662f\u8be5\u516c\u53f8\u7b2c\u4e00\u6b21\u63a5\u89e6\u7684\u533b\u836f\u4ea7\u54c1\u51fa\u53e3\u8d38\u6613\u3002<\/p>\n

\u539f\u4e2d\u4fe1\u516c\u53f8\u9752\u84bf\u7d20\u9879\u76ee\u7ecf\u7406\u5218\u5929\u4f1f\u5728\u6700\u521d\u63a5\u89e6\u5230\u9752\u84bf\u7d20\u9879\u76ee\u65f6\uff0c\u521a\u4ece\u5927\u5b66\u6bd5\u4e1a\u4e0d\u4e45\u3002\u636e\u4ed6\u56de\u5fc6\uff0c\u7531\u4e8e\u5f53\u65f6\u4e2d\u56fd\u7684\u533b\u836f\u4ea7\u54c1\u4e0d\u66fe\u8de8\u51fa\u8fc7\u56fd\u95e8\uff0c\u52a0\u4e4b\u53c2\u4e0e\u9879\u76ee\u7684\u4eba\u5458\u4e2d\u7f3a\u4e4f\u533b\u836f\u9886\u57df\u4eba\u624d\uff0c\u6700\u521d\u4ed6\u4eec\u53ea\u80fd\u628a\u9752\u84bf\u7d20\u9879\u76ee\u6309\u5bfb\u5e38\u8d38\u6613\u9879\u76ee\u6765\u8ba4\u8bc6\u548c\u8fd0\u4f5c\u3002<\/p>\n

\u6839\u636e\u8fc7\u5f80\u7ecf\u9a8c\uff0c\u4e2d\u4fe1\u6700\u5148\u60f3\u5230\u7684\u529e\u6cd5\u5c31\u662f\u76f4\u63a5\u51fa\u53e3\u3002\u5218\u5929\u4f1f\u56de\u5fc6\uff0c\u4ed6\u4eec\u6700\u521d\u5411\u8d8a\u5357\u3001\u9a6c\u6765\u897f\u4e9a\u3001\u5df4\u897f\u3001\u8d1d\u5b81\u7b49\u759f\u75be\u9ad8\u8d1f\u62c5\u56fd\u5bb6\u51fa\u53e3\u84bf\u7532\u919a\u548c\u9752\u84bf\u7425\u916f\u65f6\uff0c\u5747\u5c61\u5c61\u78b0\u58c1\uff0c\u201c\u5f53\u65f6\u8fd8\u6709\u4eba\u89c9\u5f97\u975e\u6d32\u90a3\u4e48\u7a77\uff0c\u4e2d\u56fd\u80fd\u7528\u7684\u836f\u975e\u6d32\u51ed\u4ec0\u4e48\u4e0d\u80fd\u7528\uff0c\u4f46\u5b9e\u9645\u4e0a\u975e\u6d32\u7684\u836f\u5ba1\u6807\u51c6\u66f4\u897f\u5316\u3002\u201d<\/p>\n

\u4ed6\u8fd8\u5728\u8bbf\u8c08\u4e2d\u8bc4\u8bba\u9053\uff0c\u201c\uff08\u836f\u54c1\u51fa\u53e3\uff09\u9700\u8981\u4e34\u5e8a\u8bd5\u9a8c\uff08\u7ed3\u679c\uff09\u548c\u836f\u54c1\u6ce8\u518c\uff0c\u800c\u56fd\u5185\u7684\u4f01\u4e1a\u53c8\u4e0d\u5177\u5907\u89c4\u8303\u8d44\u6599\u3002\u201d<\/p>\n

\u76f4\u5230\u8fd9\u65f6\uff0c\u8001\u79d1\u5b66\u5bb6\u4eec\u624d\u9010\u6e10\u610f\u8bc6\u5230\uff0c\u9752\u84bf\u7d20\u51fa\u6d77\u5931\u8d25\u5e76\u975e\u662f\u56fd\u5916\u6709\u610f\u6253\u538b\uff0c\u800c\u662f\u836f\u54c1\u786e\u5b9e\u5b58\u5728\u201c\u5148\u5929\u4e0d\u8db3\u201d\uff0c\u4e0d\u7b26\u5408\u56fd\u9645\u516c\u8ba4\u7684\u6807\u51c6\uff0c\u60f3\u8981\u8d70\u51fa\u53bb\uff0c\u201c\u5c31\u5fc5\u987b\u4ee5\u79d1\u5b66\u7684\u6001\u5ea6\uff0c\u5b9e\u4e8b\u6c42\u662f\u5730\u6309\u836f\u54c1\u7684\u5e02\u573a\u89c4\u5f8b\u529e\u4e8b\u3002\u201d \u7126\u5cab\u537f\u8bf4[9]\u3002<\/p>\n

\u4e00\u8fb9\u8c08\u5224\uff0c\u4e00\u8fb9\u8865\u8bfe<\/strong><\/p>\n

\u4e3a\u63a8\u5e7f\u9752\u84bf\u7c7b\u836f\u7269\uff0c\u4e2d\u4fe1\u516c\u53f8\u4e0e\u519b\u4e8b\u533b\u5b66\u79d1\u5b66\u9662\u5fae\u751f\u7269\u6d41\u884c\u75c5\u7814\u7a76\u6240\u3001\u6606\u660e\u5236\u836f\u5382\u7ec4\u6210\u79d1\u5de5\u8d38\u8054\u5408\u4f53\uff0c\u91c7\u53d6\u4e86\u4e0e\u56fd\u9645\u4e0a\u77e5\u540d\u533b\u836f\u516c\u53f8\u5408\u4f5c\u7684\u7b56\u7565\u3002<\/p>\n

\u5728\u4e0e\u6cd5\u56fd\u7f57\u7eb3\u666e\u6717\u514b\u516c\u53f8\uff08\u540e\u5e76\u5165\u8d5b\u8bfa\u83f2\u516c\u53f8\uff09\u4ec5\u8fbe\u6210\u8d38\u6613\u6027\u8d28\u7684\u84bf\u7532\u919a\u6ce8\u5c04\u5242\u539f\u6599\u51fa\u53e3\u5408\u4f5c\u540e\uff0c\u84bf\u7532\u919a\u6ce8\u5c04\u5242\u4e5f\u6210\u7b2c\u4e00\u4e2a\u4ee5\u56fd\u5916\u516c\u53f8\u54c1\u724c\u9500\u552e\u7684\u9752\u84bf\u7d20\u7c7b\u6297\u759f\u836f\u5236\u5242\u3002\u540c\u65f6\uff0c\u4e2d\u4fe1\u516c\u53f8\u4ece\u56fd\u5bb6\u79d1\u59d4\u5f97\u5230\u745e\u58eb\u6c7d\u5df4-\u5609\u57fa\u516c\u53f8\uff08CIBA-GEIGY\uff0c\u7b80\u79f0CIBA\uff09\u613f\u610f\u5546\u8c08\u5408\u4f5c\u7684\u4fe1\u606f\u3002\u6c7d\u5df4-\u5609\u57fa\u662f\u5f53\u65f6\u745e\u58eb\u6700\u5927\u7684\u5316\u5de5\u516c\u53f8\uff0c1976\u5e74\u5373\u6210\u7acb\u4e86\u53ef\u6301\u7eed\u53d1\u5c55\u57fa\u91d1\u4f1a\uff0c\u5b97\u65e8\u5c31\u662f\u4e3a\u8d2b\u7a77\u56fd\u5bb6\u5927\u89c4\u6a21\u4eba\u53e3\u6d41\u884c\u75be\u75c5\u627e\u5230\u65b0\u7684\u6cbb\u7597\u836f\u7269\u3002\u81ea1987\u5e74\u5efa\u7acb\u5317\u4eac\u7b2c\u4e00\u5bb6\u4e2d\u5916\u533b\u836f\u5408\u8d44\u4f01\u4e1a\u4ee5\u6765\uff0cCIBA\u7ecf\u5e38\u4e0e\u56fd\u5bb6\u79d1\u59d4\u76f8\u5173\u90e8\u95e8\u8054\u7cfb\u4ea4\u6d41\uff0c\u540e\u8005\u5f97\u4ee5\u5411\u5176\u4ecb\u7ecd\u4e2d\u56fd\u7684\u9752\u84bf\u7d20\u7c7b\u836f\u7269\u9879\u76ee\uff0c\u5e0c\u671b\u4fc3\u6210\u56fd\u9645\u5408\u4f5c\uff0c\u800c\u9752\u84bf\u7d20\u7c7b\u6297\u759f\u836f\u6b63\u597d\u7b26\u5408\u5176\u57fa\u91d1\u4f1a\u7684\u7406\u5ff5\uff0cCIBA\u5bf9\u6b64\u5145\u6ee1\u5174\u8da3[10]\u3002<\/p>\n

<\/p>\n

1990\u5e74\uff0c\u4e2d\u4fe1\u516c\u53f8\u4e0e\u6cd5\u56fd\u7f57\u7eb3\u666e\u6717\u514b\u516c\u53f8\u7b7e\u7f72\u84bf\u7532\u919a\u6ce8\u5c04\u5242\u56fd\u9645\u63a8\u5e7f\u534f\u8bae\u3002<\/p>\n

\u7ecf\u8fc7\u4e00\u5e74\u7684\u63a5\u89e6\uff0c1990\u5e744\u6708\uff0cCIBA\u4e0e\u4e2d\u4fe1\u516c\u53f8\u5728\u4eac\u4e3e\u884c\u9996\u6b21\u6b63\u5f0f\u4f1a\u8c08\u3002<\/p>\n

\u4f1a\u4e0a\uff0c\u4e2d\u65b9\u6700\u521d\u63a8\u8350\u7684\u662f\u901a\u8fc7\u56fd\u5185\u65b0\u836f\u5ba1\u6279\u7684\u9752\u84bf\u7d20\u884d\u751f\u7269\u84bf\u7532\u919a\u3001\u9752\u84bf\u7425\u916f\u5355\u65b9\u7c7b\u836f\u7269\uff0c\u4f46\u56e0\u4e0d\u80fd\u7533\u8bf7\u56fd\u9645\u4e13\u5229\u548c\u6548\u679c\u4e0d\u7406\u60f3\u7b49\u56e0\u7d20\u88abCIBA\u62d2\u7edd\u3002\u5e94\u745e\u58eb\u4e13\u5bb6\u7684\u8be2\u95ee\uff0c\u4e2d\u65b9\u4e13\u5bb6\u548c\u9886\u5bfc\u4eec\u95ed\u95e8\u5546\u91cf\u540e\uff0c\u624d\u900f\u9732\u8bf4\u56fd\u5185\u7814\u7a76\u7684\u4e00\u6b3e\u590d\u65b9\u6297\u759f\u836f\u6b63\u5728\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\uff0cCIBA\u4e13\u5bb6\u4e3b\u52a8\u8981\u6c42\u4e2d\u65b9\u4e0d\u8981\u7ee7\u7eed\u4ecb\u7ecd\u5185\u5bb9\uff0c\u7b49\u7b7e\u7f72\u65b0\u7684\u4fdd\u5bc6\u534f\u8bae\u540e\u518d\u8bf4\u3002<\/p>\n

\u5f53\u65f6\uff0c\u4e0e\u5916\u65b9\u5408\u4f5c\u5f00\u53d1\u590d\u65b9\u6297\u759f\u836f\uff0c\u5e76\u5236\u6210\u4ea7\u54c1\u63a8\u5165\u56fd\u9645\u5e02\u573a\uff0c\u5c31\u9700\u8981\u5c06\u77e5\u8bc6\u4ea7\u6743\u8f6c\u8ba9\u7ed9\u5916\u65b9\uff0c\u8fd9\u4e0e\u5355\u65b9\u836f\u7684\u76f4\u63a5\u5408\u4f5c\u8d38\u6613\u4e0d\u540c\uff0c\u96be\u514d\u8ba9\u8001\u79d1\u5b66\u5bb6\u4eec\u611f\u5230\u8fdf\u7591\u3002\u4f46\u534a\u5e74\u540e\uff0c\u7ecf\u8bc4\u4f30\u548c\u8d44\u6599\u5ba1\u67e5\uff0cCIBA\u8ba4\u5b9a\u590d\u65b9\u84bf\u7532\u919a\u6709\u53ef\u80fd\u83b7\u5f97\u56fd\u9645\u4e13\u5229\uff0c\u5c06\u5176\u79f0\u4e3a\u201c\u5317\u4eac\u9e2d\u4e0b\u7684\u91d1\u86cb\u201d\u3002\u5218\u5929\u4f1f\u8ba4\u4e3a\uff0c\u8fd9\u8bc1\u660e\u4e86\u5373\u4f7f\u5f53\u65f6\u5b9e\u65bdGMP\u7684\u6761\u4ef6\u4e0d\u8db3\uff0c\u590d\u65b9\u84bf\u7532\u919a\u4f9d\u7136\u662f\u4e00\u9879\u8d70\u5728\u56fd\u9645\u524d\u6cbf\u7684\u521b\u65b0\u6027\u6210\u679c\u3002<\/p>\n

<\/p>\n

1990\u5e74\uff0cWHO\u4e13\u5bb6\u68c0\u67e5\u6606\u660e\u5236\u836fGMP\u3002<\/p>\n

\u5728CIBA\u7684\u5e2e\u52a9\u4e0b\uff0c\u7ecf\u5386\u4e86\u8270\u96be\u7684\u56fd\u9645\u4e13\u5229\u7533\u8bf7\u8fc7\u7a0b\u540e\uff0c\u4e2d\u56fd\u539f\u7814\u7684\u590d\u65b9\u84bf\u7532\u919a\u4ece\u4e13\u5229\u5230\u5546\u54c1\u770b\u8d77\u6765\u53ea\u5269\u4e34\u95e8\u4e00\u811a\u4e86\u3002\u4f46\u7531\u4e8e\u5148\u524d\u4e2d\u56fd\u79d1\u5b66\u5bb6\u6240\u505a\u7684400\u591a\u4f8b\u4e34\u5e8a\u8bd5\u9a8c\u5e76\u4e0d\u7b26\u5408\u6807\u51c6\uff0c\u745e\u65b9\u6000\u7591\u590d\u65b9\u84bf\u7532\u919a\u7684\u7597\u6548\u662f\u5426\u771f\u5b9e\uff0c\u8981\u6c42\u53cc\u65b9\u7b7e\u8ba2\u4e13\u5229\u8bb8\u53ef\u5408\u4f5c\u534f\u8bae\u524d\uff0c\u7531\u745e\u65b9\u51fa\u65b9\u6848\u51fa\u94b1\uff0c\u4e2d\u65b9\u6309GCP\u6807\u51c6\u518d\u505a100\u4f8b\u4e34\u5e8a\u8bd5\u9a8c\uff0cCIBA\u516c\u53f8\u4f1a\u6d3e\u76d1\u7763\u5458(Monitor)\u5168\u7a0b\u53c2\u4e0e\u3002<\/p>\n

\u4f46\u5728\u5f53\u65f6\uff0c\u4e2d\u56fd\u65e2\u6ca1\u6709GCP\u4e34\u5e8a\u8bd5\u9a8c\u57fa\u5730\uff0c\u4e5f\u672a\u5efa\u7acbGCP\u6807\u51c6\uff0c\u5bf9\u4e8e\u627f\u62c5\u8fd9\u6b21\u4e34\u5e8a\u8bd5\u9a8c\u7684\u4e09\u4e9a\u5e02\u519c\u57a6\u533b\u9662\u800c\u8a00\uff0cGCP\u66f4\u662f\u4e00\u4e2a\u5168\u65b0\u7684\u540d\u8bcd\uff0c\u4ed6\u4eec\u8981\u6311\u6218\u6b64\u524d\u4ece\u672a\u505a\u8fc7\u7684\u9ad8\u6807\u51c6\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/p>\n

\u597d\u5728\u8d1f\u8d23\u6b64\u6b21\u9009\u62e9\u8bd5\u9a8c\u533b\u9662\u7684\u7126\u5cab\u537f\uff0c\u975e\u5e38\u4e86\u89e3\u5f53\u65f6\u56fd\u5185\u5916GCP\u6807\u51c6\u548c\u8ba4\u77e5\u7684\u5dee\u8ddd\uff0c\u4ed6\u63d0\u51fa\u5c06\u533b\u9662\u5df2\u6709\u7684\u89c4\u7ae0\u5236\u5ea6\u3001\u5404\u7ea7\u4eba\u5458\u804c\u8d23\u88c5\u8ba2\u6210\u518c\u5e76\u4e88\u4ee5\u547d\u540d\uff1b\u5c06\u76f8\u5173\u4eea\u5668\u8bbe\u5907\u4f7f\u7528\u8bf4\u660e\u4e66\u4e2d\u7684\u64cd\u4f5c\u89c4\u7a0b\u90e8\u5206\u6458\u5f55\u51fa\u6765\u5e76\u653e\u5728\u4eea\u5668\u8fb9\uff0c\u7ef4\u4fee\u4fdd\u517b\u8bb0\u5f55\u51c6\u5907\u597d\u4ee5\u5f85\u68c0\u67e5\uff1b\u75c5\u623f\u4fdd\u969c\u8db3\u591f\u7684\u5e8a\u4f4d\uff0c\u5e76\u505a\u597d\u6d88\u6bd2\u3001\u6740\u866b\u3001\u9632\u868a\u5de5\u4f5c\u7b49\u5efa\u8bae\u3002\u6700\u7ec8\uff0c\u519c\u57a6\u533b\u9662\u867d\u672a\u5b8c\u5168\u8fbe\u5230GCP\u6807\u51c6\uff0c\u4f46\u57fa\u672c\u80fd\u6ee1\u8db3\u8bd5\u9a8c\u8981\u6c42\u3002\u5728\u745e\u65b9\u7684\u5b9e\u9a8c\u8bbe\u5907\u652f\u6301\u4e0b\uff0c\u7ecf\u8fc7\u4e3a\u671f5\u4e2a\u6708\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u590d\u65b9\u84bf\u7532\u919a\u7684\u7597\u6548\u518d\u6b21\u5f97\u5230\u8bc1\u5b9e[8]\u3002<\/p>\n

\u4e2d\u745e\u53cc\u65b9\u4ea4\u6d41\u65f6\u95f4\u957f\u4e86\uff0c\u76f8\u4e92\u4fe1\u4efb\u548c\u7406\u89e3\u9010\u6b65\u52a0\u6df1\u3002\u51e0\u5e74\u6765\u5728\u745e\u65b9\u7684\u76d1\u7763\u548c\u652f\u6301\u4e0b\uff0c\u4e2d\u65b9\u4e00\u8fb9\u8c08\u5224\uff0c\u4e00\u8fb9\u8865\u8bfe\uff0c\u53c8\u7ecf\u53d7\u4f4f\u4e86\u51e0\u6b21GCP\u53caGLP\u6807\u51c6\u7684\u8003\u5bdf\u3002<\/p>\n

1994\u5e749\u670820\u65e5\uff0c\u53cc\u65b9\u4e8e\u6b63\u5f0f\u7b7e\u7f72\u300a\u8bb8\u53ef\u548c\u5f00\u53d1\u534f\u8bae\u300b\uff0c\u8fd9\u4e0e\u53cc\u65b9\u7b2c\u4e00\u6b21\u7b7e\u7f72\u5907\u5fd8\u5f55\u8fc7\u53bb\u4e864\u5e74\u591a\u7684\u65f6\u95f4\u3002<\/p>\n

<\/p>\n

1994\u5e74\u4e2d\u745e\u53cc\u65b9\u7b7e\u7f72\u4e13\u5229\u5b9e\u65bd\u534f\u8bae\u3002<\/p>\n

\u6839\u636e\u534f\u8bae\uff0cCIBA\u4e00\u6b21\u6027\u652f\u4ed8\u4e2d\u65b9150\u4e07\u7f8e\u5143\u524d\u671f\u79d1\u7814\u8865\u507f\u8d39\uff1b\u5e76\u5728\u4e13\u5229\u6709\u6548\u671f\u5185\uff0c\u6bcf\u5e74\u6309\u590d\u65b9\u84bf\u7532\u919a\u51c0\u9500\u552e\u989d\u76844%\u4f5c\u4e3a\u4e2d\u65b9\u4e13\u5229\u8bb8\u53ef\u4f7f\u7528\u8d39\uff0c\u63d0\u621020\u5e74\uff1b\u590d\u65b9\u4e2d\u7684\u4e24\u4e2a\u539f\u6599\u836f\u4e5f\u7531\u4e2d\u65b9\u72ec\u4f9b\u3002\u7126\u5cab\u537f\u66fe\u900f\u9732\uff0c\u6709\u5173\u90e8\u95e8\u8bc1\u5b9e\uff0c\u6b64\u6b21\u65b0\u836f\u56fd\u9645\u5408\u4f5c\u83b7\u5f97\u7684\u7ecf\u6d4e\u6548\u76ca\u5728\u5f53\u65f6\u5c45\u5168\u56fd\u4e4b\u9996[9]\u3002\u540e\u6765\uff0c\u6d59\u6c5f\u65b0\u660c\u5236\u836f\u5382\u4e5f\u52a0\u5165\u6b64\u9879\u76ee\uff0c\u8d1f\u8d23\u672c\u82b4\u9187\u539f\u6599\u7684\u751f\u4ea7\u3002<\/p>\n

1996\u5e74\uff0cCIBA\u4e0e\u5c71\u5fb7\u58eb\u5408\u5e76\uff0c\u7ec4\u6210\u4e86\u73b0\u5728\u7684\u5236\u836f\u5de8\u5934\u8bfa\u534e\u516c\u53f8\uff0c\u540e\u8005\u9700\u5bf9\u5408\u5e76\u524d\u542f\u52a8\u4e14\u6b63\u5728\u8fdb\u884c\u7684\u9879\u76ee\u8fdb\u884c\u5185\u90e8\u5ba1\u67e5\u548c\u7b5b\u9009\u3002\u65f6\u4efb\u8bfa\u534e\u516c\u53f8\u65b0CEO\u7684\u4e39\u5c3c\u5c14\u00b7\u9b4f\u601d\u4e50\u575a\u6301\u4ee5\u7597\u6548\u6765\u786e\u8ba4\u65b0\u836f\u5f00\u53d1\u9879\u76ee\uff0c\u590d\u65b9\u84bf\u7532\u919a\u4f18\u5f02\u7684\u7597\u6548\u8ba9\u4ed6\u8ba4\u8bc6\u5230\u8be5\u836f\u5bf9\u8d2b\u7a77\u60a3\u8005\u7684\u610f\u4e49\uff0c\u5408\u4f5c\u9879\u76ee\u56e0\u6b64\u5f97\u4ee5\u4fdd\u7559\uff0c\u8bfa\u534e\u516c\u53f8\u4e5f\u968f\u4e4b\u6210\u4e3a20\u4e16\u7eaa\u4e2d\u5168\u7403\u7b2c\u4e00\u5bb6\u63a8\u51fa\u6709\u660e\u786e\u63a8\u8350\u4f7f\u7528\u5242\u91cf\u7684\u9752\u84bf\u7d20\u8054\u5408\u836f\u54c1\uff08ACT\uff09\u7684\u5236\u836f\u516c\u53f8\u3002<\/p>\n

\u6b64\u540e\u6570\u5e74\u91cc\uff0c\u8bfa\u534e\u516c\u53f8\u4e3a\u590d\u65b9\u84bf\u7532\u919a\u5728\u5168\u7403\u505a\u4e86\u5f88\u591a\u5de5\u4f5c\uff0c\u5305\u62ec\u591a\u4e2d\u5fc3\u4e34\u5e8a\u8bd5\u9a8c\u3001\u5242\u578b\u518d\u5f00\u53d1\uff0c\u4ee5\u53ca\u538b\u7247\u5de5\u827a\u3001WHO\u4f9d\u4ece\u6027\u5305\u88c5\uff08\u5361\u7247\u5f0f\uff09\u8bbe\u8ba1\u7b49\u65b9\u9762\u7684\u521b\u65b0\uff0c\u5e76\u91c7\u53d6\u53cc\u54c1\u724c\u3001\u6210\u672c\u4ef7\u683c\u3001\u591a\u79cd\u4f9d\u4ece\u6027\u5305\u88c5\u3001\u624b\u673a\u77ed\u4fe1\u5e93\u5b58\u7ba1\u7406\u7684\u65b0\u6a21\u5f0f\uff0c\u53c2\u4e0e\u591a\u6837\u7684\u56fd\u9645\u884c\u52a8\uff0c\u5c06\u836f\u54c1\u9001\u5230\u975e\u6d32\u504f\u8fdc\u6751\u5e84\uff0c\u7279\u522b\u662f\u513f\u7ae5\u759f\u75be\u60a3\u8005\u7684\u624b\u4e2d\u3002<\/p>\n

\u6b64\u5916\uff0c\u8bfa\u534e\u516c\u53f8\u8fd8\u6301\u7eed\u591a\u5e74\u6d3e\u51fa\u591a\u4f4d\u4e13\u5bb6\u6307\u5bfc\u4e2d\u56fd\u836f\u4f01\u8fdb\u884cGMP\u6539\u9020\u548c\u7ef4\u6301\u3002\u5176\u4e2d\uff0c\u6606\u660e\u5236\u836f\u548c\u6d59\u6c5f\u65b0\u660c\u5236\u836f\u5747\u5728\u51e0\u5e74\u5185\u5206\u522b\u901a\u8fc7\u4e86WHO\u548c\u7f8e\u56fdFDA\u7684GMP\u68c0\u67e5\uff0c\u590d\u65b9\u84bf\u7532\u919a\u4e5f\u987a\u5229\u901a\u8fc7\u4e86\u5728\u7f8e\u56fd\u7684\u6ce8\u518c\u3002\u901a\u8fc7\u4e0e\u8bfa\u534e\u516c\u53f8\u7684\u5408\u4f5c\uff0c\u8fd1\u5e74\u6765\u6d59\u6c5f\u65b0\u660c\u7684\u5236\u836f\u6280\u672f\u6c34\u5e73\u5b9e\u529b\u4e0d\u65ad\u589e\u5f3a\uff0c\u5728\u590d\u65b9\u84bf\u7532\u919a\u9879\u76ee\u4e2d\u4ece\u539f\u6599\u836f\u7684\u4f9b\u5e94\u5546\u5347\u683c\u4e3a\u5927\u5305\u88c5\u5236\u5242\u7684\u4f9b\u5e94\u5546\u3002\u591a\u4f4d\u4eb2\u5386\u8fd9\u6bb5\u5408\u4f5c\u5386\u7a0b\u7684\u8001\u79d1\u5b66\u5bb6\u5747\u8ba4\u4e3a\uff0c\u5982\u679c\u6ca1\u6709\u8fd9\u6b21\u56fd\u9645\u5408\u4f5c\uff0c\u590d\u65b9\u84bf\u7532\u919a\u6050\u96be\u6210\u529f\u8fdb\u5165\u56fd\u9645\u5e02\u573a\uff0c\u65b0\u836f\u7814\u53d1\u3001\u751f\u4ea7\u4e5f\u5f88\u96be\u8fc5\u901f\u5b9e\u73b0\u4e0e\u56fd\u9645\u5148\u8fdb\u6280\u672f\u6807\u51c6\u63a5\u8f68\u3002<\/p>\n

<\/p>\n

2006\u5e74\u8bfa\u534e\u516c\u53f8\u4e13\u5bb6\u8bb2\u6388GMP\u7ba1\u7406\u3002<\/p>\n

\u9664\u4e86\u5b9e\u4e8b\u6c42\u662f\u7684\u79d1\u5b66\u6001\u5ea6\uff0c\u5218\u5929\u4f1f\u8ba4\u4e3a\uff0c\u56fd\u9645\u5408\u4f5c\u4e2d\u7684\u6c9f\u901a\u4e0e\u534f\u8c03\u4e5f\u5f88\u91cd\u8981\u3002\u5728\u4e2d-\u7f8e-WHO\u5408\u4f5c\u65f6\u671f\uff0c\u4e09\u65b9\u4e4b\u95f4\u672a\u80fd\u5f62\u6210\u6709\u6548\u7684\u6c9f\u901a\u4e0e\u534f\u8c03\uff1b\u800c\u4e2d\u4fe1\u516c\u53f8\u5728\u590d\u65b9\u84bf\u7532\u919a\u7684\u5408\u4f5c\u4e2d\u53d1\u6325\u4e86\u201c\u7f13\u51b2\u6c60\u201d\u4f5c\u7528\uff0c\u4e00\u65b9\u9762\u4ece\u6574\u4f53\u6548\u76ca\u51fa\u53d1\u8981\u6c42\u8bfa\u534e\u516c\u53f8\u52aa\u529b\u5f00\u62d3\u6d77\u5916\u5e02\u573a\uff0c\u5e76\u8d1f\u8d23\u7763\u4fc3\u4e2d\u56fd\u4f01\u4e1a\u901a\u8fc7GMP\uff1b\u53e6\u4e00\u65b9\u9762\u4e5f\u7ad9\u5728\u4e2d\u56fd\u4f01\u4e1a\u7684\u89d2\u5ea6\uff0c\u5411\u8bfa\u534e\u516c\u53f8\u8981\u6c42\u4eba\u5458\u548c\u6280\u672f\u652f\u6301\uff0c\u4e14\u5728\u5e02\u573a\u9700\u6c42\u4e0d\u65ad\u589e\u52a0\u65f6\uff0c\u534f\u8c03\u4f18\u5148\u7a33\u5b9a\u4e2d\u56fd\u539f\u6599\u836f\u4f9b\u8d27\u8ba2\u5355\u7684\u4ef7\u683c\u4e0e\u6570\u91cf\u3002<\/p>\n

\u201c\u4e2d\u4fe1\u516c\u53f8\u6240\u53c2\u4e0e\u7684\u4e2d\u56fd\u9752\u84bf\u7d20\u7c7b\u6297\u759f\u65b0\u836f\u56fd\u9645\u5316\u8fc7\u7a0b\uff0c\u4f34\u968f\u7740\u4e2d\u56fd\u6539\u9769\u5f00\u653e\u7684\u8fdb\u7a0b\u548c\u533b\u836f\u8d28\u91cf\u7ba1\u7406\u4e0d\u65ad\u63d0\u5347\u8fdb\u6b65\u7684\u8fc7\u7a0b\u3002\u8fd9\u662f\u4e00\u79cd\u5728\u591a\u91cd\u4f19\u4f34\u5173\u7cfb\u3001\u591a\u4e2a\u6240\u5c5e\u7ba1\u7406\u90e8\u95e8\u4e0d\u540c\u7684\u5355\u4f4d\u4e4b\u95f4\u3001\u8de8\u5de5\u519c\u884c\u4e1a\u548c\u56fd\u5185\u5916\u653f\u6cbb\u7ecf\u6d4e\u73af\u5883\u7684\u590d\u6742\u5408\u4f5c\u6a21\u5f0f\u4e0b\uff0c\u6bd4\u8f83\u6210\u529f\u7684\u7ed3\u679c\u3002\u201d\u5218\u5929\u4f1f\u8bf4\u3002<\/p>\n

<\/p>\n

2009\u5e74\u519b\u79d1\u9662\u590d\u65b9\u84bf\u7532\u919a\u56e2\u961f\u8363\u83b7\u6b27\u6d32\u53d1\u660e\u4eba\u5956<\/p>\n

\u8f6c\u5411\u516c\u7acb\u5e02\u573a\uff0c\u8fce\u63a5\u65b0\u7684\u6807\u51c6\u6311\u6218<\/strong><\/p>\n

\u5c31\u5728\u4e2d\u4fe1\u516c\u53f8\u4e0eCIBA\u5408\u4f5c\u5982\u706b\u5982\u837c\u5f00\u5c55\u7684\u540c\u65f6\uff0c\u4ece1990\u5e74\u4ee3\u5f00\u59cb\uff0c\u56fd\u5185\u4e00\u4e9b\u836f\u5382\u4e5f\u5c1d\u8bd5\u5c06\u81ea\u5df1\u751f\u4ea7\u7684\u9752\u84bf\u7d20\u7c7b\u6297\u759f\u836f\u63a8\u5411\u6d77\u5916\u3002\u4ed6\u4eec\u5f88\u5feb\u53d1\u73b0\uff0c\u5c3d\u7ba1\u975e\u6d32\u56fd\u5bb6\u7ecf\u6d4e\u53d1\u5c55\u6c34\u5e73\u4e0d\u5982\u56fd\u5185\uff0c\u4f46\u836f\u54c1\u51c6\u5165\u548c\u76d1\u7ba1\u4f53\u7cfb\u5374\u90fd\u53c2\u7167\u897f\u65b9\u53d1\u8fbe\u56fd\u5bb6\u6807\u51c6\u6267\u884c\uff0c\u8fdc\u6bd4\u56fd\u5185\u5b8c\u5584\uff0c\u56fd\u4ea7\u836f\u7269\u7684\u4e34\u5e8a\u8bd5\u9a8c\u65e0\u6cd5\u6ee1\u8db3\u5728\u975e\u6d32\u56fd\u5bb6\u4e0a\u5e02\u7684\u8981\u6c42\u3002\u800c\u4e14\uff0c\u9752\u84bf\u7d20\u7c7b\u836f\u7269\u76f8\u5bf9\u8f83\u9ad8\u7684\u4ef7\u683c\u3001\u8f83\u957f\u7684\u7528\u836f\u65f6\u95f4\u4e5f\u8ba9\u5927\u591a\u975e\u6d32\u5bb6\u5ead\u65e0\u6cd5\u8d1f\u62c5\u3002<\/p>\n

\u5c3d\u7ba1\u4e2d\u56fd\u4f01\u4e1a\u521d\u5165\u975e\u6d32\u5e02\u573a\u65f6\u78b0\u4e86\u58c1\uff0c\u9752\u84bf\u7d20\u7c7b\u836f\u7269\u7684\u6548\u679c\u5374\u5f97\u5230\u4e86\u56fd\u9645\u793e\u4f1a\u7684\u5e7f\u6cdb\u8ba4\u53ef\u30022001\u5e74\uff0cWHO\u9996\u6b21\u5728\u6280\u672f\u6307\u5357\u4e2d\u63a8\u8350\u4f7f\u7528\u9752\u84bf\u7d20\u8054\u5408\u7597\u6cd5\u6cbb\u7597\u6076\u6027\u759f\uff0c\u540e\u5c06\u5176\u5217\u4e3a\u4e00\u7ebf\u7597\u6cd5\u30022002\u5e74\u6297\u51fb\u827e\u6ecb\u75c5\u3001\u7ed3\u6838\u75c5\u548c\u759f\u75be\u5168\u7403\u57fa\u91d1\uff08\u4ee5\u4e0b\u7b80\u79f0\u5168\u7403\u57fa\u91d1\uff09\u6210\u7acb\u540e\uff0c\u9752\u84bf\u7d20\u7c7b\u836f\u7269\u7684\u5168\u7403\u5e02\u573a\u4e5f\u5212\u4e3a\u516c\u3001\u79c1\u7acb\u4e24\u4e2a\u9635\u8425\uff0c\u5176\u4e2d\u516c\u7acb\u5e02\u573a\u7531\u5168\u7403\u57fa\u91d1\u4e3b\u5bfc\uff0c\u5360\u5168\u90e8\u5e02\u573a\u4efd\u989d\u768480%\u4ee5\u4e0a\u3002<\/p>\n

\u759f\u75be\u662f\u4e00\u4e2a\u201c\u7a77\u75c5\u201d\uff0c\u8d8a\u662f\u5728\u793e\u4f1a\u7ecf\u6d4e\u53d1\u5c55\u76f8\u5bf9\u843d\u540e\u7684\u5730\u533a\uff0c\u653f\u5e9c\u5c31\u8d8a\u7f3a\u4e4f\u8db3\u591f\u8d44\u91d1\u6765\u91c7\u8d2d\u68c0\u6d4b\u8bd5\u5242\u548c\u6297\u759f\u836f\uff0c\u759f\u75be\u8d1f\u62c5\u5f80\u5f80\u8d8a\u91cd\u3002\u5bf9\u6b64\uff0c\u5168\u7403\u57fa\u91d1\u91c7\u53d6\u4e86\u201c\u8584\u5229\u591a\u9500\u201d\u7684\u7b56\u7565\uff0c\u901a\u8fc7\u7ade\u6807\u548c\u8c08\u5224\u5c06\u4ea7\u54c1\u5355\u4ef7\u5927\u5e45\u538b\u4f4e\uff0c\u518d\u901a\u8fc7\u7b7e\u8ba22-3\u5e74\u7684\u5927\u4f53\u91cf\u91c7\u8d2d\u8ba2\u5355\u786e\u4fdd\u4f01\u4e1a\u80fd\u591f\u5b9e\u73b0\u76c8\u5229\u3002\u76ee\u524d\uff0c\u5168\u7403\u57fa\u91d1\u5df2\u6210\u4e3a\u5168\u7403\u6297\u759f\u4ea7\u54c1\u516c\u5171\u91c7\u8d2d\u7684\u6700\u5927\u4e3b\u4f53\uff0c\u6bcf\u5e74\u7ea62\u4ebf\u7f8e\u5143\u7528\u4e8e\u91c7\u8d2d\u6297\u759f\u836f\u3002<\/p>\n

\u516c\u7acb\u5e02\u573a\u5bb9\u91cf\u5de8\u5927\uff0c\u7ed9\u6297\u759f\u836f\u4f01\u5e26\u6765\u5f88\u5927\u53d1\u5c55\u673a\u9047\uff0c\u4f46\u95e8\u69db\u9887\u9ad8\uff1a\u53ea\u6709\u901a\u8fc7WHO\u836f\u54c1\u9884\u8ba4\u8bc1\uff08PQ\uff09\u7684\u4ea7\u54c1\u624d\u80fd\u8fdb\u5165\u8054\u5408\u56fd\u548c\u56fd\u9645\u7ec4\u7ec7\u7684\u836f\u54c1\u91c7\u8d2d\u76ee\u5f55\uff0c\u6709\u673a\u4f1a\u4e0e\u5168\u7403\u57fa\u91d1\u8fbe\u6210\u91c7\u8d2d\u534f\u8bae\u3002\u65b0\u51c6\u5165\u95e8\u69db\u7684\u51fa\u73b0\uff0c\u6709\u52a9\u4e8e\u89e3\u51b3\u56e0\u5404\u56fd\u836f\u54c1\u76d1\u7ba1\u6807\u51c6\u4e0d\u4e00\uff0c\u6216\u5f71\u54cd\u91c7\u8d2d\u836f\u54c1\u8d28\u91cf\u3001\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u95ee\u9898\u3002<\/p>\n

\u6297\u759f\u836f\u65b9\u9762\uff0c\u66fe\u4e0e\u4e2d\u56fd\u6210\u529f\u5408\u4f5c\u7684\u8bfa\u534e\u516c\u53f8\u65e9\u57282004\u5e74\u5c31\u901a\u8fc7\u4e86\u590d\u65b9\u84bf\u7532\u919a\u7684WHO\u9884\u8ba4\u8bc1\uff0c\u6210\u4e3a\u5168\u7403\u57fa\u91d1\u6297\u759f\u836f\u7269\u6700\u5927\u7684\u4f9b\u5e94\u5546\uff0c\u52302011\u5e74\uff0c\u5176\u5360\u516c\u7acb\u5e02\u573a\u4efd\u989d\u768450%\uff0c\u8d5b\u8bfa\u83f2\u548c\u5370\u5ea6\u4eff\u5236\u836f\u4f01\u7684\u6297\u759f\u836f\u4e5f\u76f8\u7ee7\u901a\u8fc7WHO\u9884\u8ba4\u8bc1\uff0c\u5404\u536020%\uff0c\u201c\u4e09\u8db3\u9f0e\u7acb\u201d\u7684\u5e02\u573a\u683c\u5c40\u9010\u6e10\u5f62\u6210\u3002\u5269\u4e0b10%\u7684\u516c\u7acb\u5e02\u573a\u5219\u7531\u5404\u56fd\u4f01\u4e1a\u74dc\u5206\uff0c\u4e2d\u4f01\u4e5f\u5728\u5176\u4e2d[11]\u3002<\/p>\n

\u6842\u6797\u5357\u836f\uff08\u590d\u661f\u533b\u836f\uff09\u662f\u76ee\u524d\u56fd\u5185\u552f\u4e00\u4e00\u5bb6\u62e5\u6709\u9752\u84bf\u7d20\u836f\u7269WHO\u9884\u8ba4\u8bc1\u7684\u4f01\u4e1a\u3002\u5c3d\u7ba1\u5176\u751f\u4ea7\u7684\u9752\u84bf\u7425\u916f\u57281987\u5e74\u5c31\u83b7\u5f97\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u536b\u751f\u90e8\u9881\u53d1\u7684\u65b0\u836f\u8bc1\u4e66\uff0887\u536b\u836f\u8bc1\u5b57X-01\u53f7\uff09\uff0c\u4f46\u7531\u4e8e\u5f53\u65f6\u6ca1\u6709\u4e00\u5bb6\u4e2d\u56fd\u5236\u836f\u516c\u53f8\u7b26\u5408\u4e16\u536b\u7ec4\u7ec7\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff0c\u56e0\u6b64\u4ea7\u54c1\u8fdf\u8fdf\u672a\u80fd\u8fdb\u5165\u56fd\u9645\u5e02\u573a[12]\u30021988\u5e74\uff0c\u6842\u6797\u5236\u836f\u5382\u4e0e\u6cd5\u56fd\u8d5b\u8bfa\u83f2\u5723\u5fb7\u62c9\u5821\u96c6\u56e2\uff08Sanofi-Synthelabo\uff09\u8fdb\u884c\u4ee3\u5de5\u5408\u4f5c\uff0c\u5176\u751f\u4ea7\u7684\u9752\u84bf\u7425\u916f\u7247\u4ea4\u7531\u540e\u8005\u8d34\u724c\u9500\u552e\u3002\u8fd9\u6b21\u5408\u4f5c\u4e5f\u5927\u5e45\u63d0\u5347\u4e86\u6842\u6797\u5236\u836f\u5382\u7684\u6574\u4f53\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u6c34\u5e73\u3002<\/p>\n

<\/p>\n

1977\u5e74\uff0c\u9752\u84bf\u7425\u916f\u53d1\u660e\u4eba\u3001\u6842\u6797\u5357\u836f\uff08\u524d\u8eab\u4e3a\u6842\u6797\u5236\u836f\u5382\uff09\u603b\u5de5\u7a0b\u5e08\u5218\u65ed\u5728\u4e2d\u8bd5\u8bd5\u9a8c\u5ba4\u3002<\/p>\n

2003\u5e74\uff0c\u590d\u661f\u533b\u836f\u6536\u8d2d\u6842\u6797\u5357\u836f\u540e\uff0c\u770b\u5230\u4e86\u9752\u84bf\u7425\u916f\u7684\u56fd\u9645\u4ef7\u503c\uff0c\u5bf9\u9752\u84bf\u7d20\u7c7b\u4ea7\u54c1\u8fdb\u884c\u6539\u9020\uff0c\u540c\u65f6\u542f\u52a8WHO\u9884\u8ba4\u8bc1\u7533\u8bf7\u6d41\u7a0b\uff0c\u4e8e2005\u5e74\u83b7\u5f97\u4e86\u9752\u84bf\u7425\u916f\u7247\u7684WHO\u9884\u8ba4\u8bc1\uff0c\u6210\u4e3a\u9996\u4e2a\u901a\u8fc7WHO\u9884\u8ba4\u8bc1\u7684\u4e2d\u56fd\u9752\u84bf\u7d20\u7c7b\u6297\u759f\u836f\u5236\u5242\u3002\u968f\u540e\u53c8\u4e8e2006\u5e74\u83b7\u5f97\u76d0\u9178\u963f\u83ab\u5730\u55b9\u7247\u7684WHO\u9884\u8ba4\u8bc1\uff0c\u6210\u4e3a\u7ee7\u8bfa\u534e\u516c\u53f8\u540e\u6700\u65e9\u4e00\u6279\u901a\u8fc7WHO\u9884\u8ba4\u8bc1\u7684\u6297\u759f\u836f\u751f\u4ea7\u5546[13]\u3002<\/p>\n

\u5c3d\u7ba1\u9752\u84bf\u7425\u916f\u7247\u83b7\u5f97\u4e86WHO\u9884\u8ba4\u8bc1\uff0c\u4f46\u57282005\u5e74\uff0c\u4e2d\u4f01\u7684\u9500\u552e\u6e20\u9053\u548c\u56fd\u9645\u77e5\u540d\u5ea6\u8fdc\u4e0d\u53ca\u8bfa\u534e\u548c\u8d5b\u8bfa\u83f2\uff0c\u5373\u4fbf\u6709\u539f\u6599\u751f\u4ea7\u548c\u4ef7\u683c\u4f18\u52bf\uff0c\u9752\u84bf\u7425\u916f\u7247\u5728\u53e3\u670d\u6297\u759f\u836f\u5e02\u573a\u7684\u7ade\u4e89\u529b\u975e\u5e38\u6709\u9650\uff0c\u672a\u83b7\u5f97\u592a\u591a\u516c\u7acb\u5e02\u573a\u8ba2\u5355\uff0c\u4e8e\u662f\u6842\u6797\u5357\u836f\u5c06\u91cd\u70b9\u8f6c\u5411\u6ce8\u5c04\u7528\u9752\u84bf\u7425\u916f\uff0c\u5e76\u4e8e\u540c\u5e74\u542f\u52a8\u4e86\u6ce8\u5c04\u7528\u9752\u84bf\u7425\u916f\u7684WHO\u9884\u8ba4\u8bc1\u9879\u76ee[14]\u3002<\/p>\n

\u9884\u8ba4\u8bc1\u7533\u8bf7\u521a\u5f00\u59cb\u5e76\u4e0d\u987a\u5229\uff0c\u5b66\u4e60\u548c\u7406\u89e3WHO\u7684\u6807\u51c6\u662f\u4e00\u5927\u6311\u6218\u3002\u5bfb\u6c42\u56fd\u9645\u5408\u4f5c\u518d\u6b21\u6210\u4e3a\u7a81\u7834\u53e3\uff0c\u759f\u75be\u836f\u54c1\u4e8b\u4e1a\u4f1a\uff08Medicines for Malaria Venture\uff0c\u7b80\u79f0 MMV\uff09\u968f\u4e4b\u8fdb\u5165\u89c6\u7ebf\u3002<\/p>\n

MMV\u662f\u4e00\u4e2a\u975e\u8425\u5229\u6027\u56fd\u9645\u7ec4\u7ec7 \uff0c\u81f4\u529b\u4e8e\u5f00\u53d1\u548c\u4fc3\u8fdb\u521b\u65b0\u6709\u6548\u7684\u6297\u759f\u836f\uff0c\u5e76\u786e\u4fdd\u5176\u80fd\u591f\u60e0\u53ca\u5f31\u52bf\u7fa4\u4f53\u30022008\u5e74\uff0c\u6842\u6797\u5357\u836f\u53c2\u52a0\u7531MMV\u4e3e\u529e\u7684\u9752\u84bf\u7d20\u4f9b\u5e94\u56fd\u9645\u7814\u8ba8\u4f1a\u65f6\uff0c\u63d0\u51fa\u4e86\u5f53\u524d\u4f01\u4e1a\u9762\u4e34\u7684GMP\u6311\u6218\uff0c\u5f15\u8d77MMV\u7684\u5173\u6ce8[15]\u3002\u53cc\u65b9\u968f\u540e\u8fbe\u6210\u6ce8\u5c04\u7528\u9752\u84bf\u7425\u916f\u7533\u8bf7WHO\u9884\u8ba4\u8bc1\u7684\u5408\u4f5c\u534f\u8bae\uff0c\u7531MMV\u63d0\u4f9b\u6709\u9488\u5bf9\u6027\u7684\u54a8\u8be2\u3001\u6307\u5bfc\u548c\u57f9\u8bad\uff0c\u786e\u4fdd\u5176\u6ce8\u5c04\u7528\u9752\u84bf\u7425\u916f\u7684\u751f\u4ea7\u8bbe\u65bd\u548c\u5de5\u827a\u7b26\u5408\u7b26\u5408\u9884\u8ba4\u8bc1\u6807\u51c6\u30022010\u5e74\uff0c\u6ce8\u5c04\u7528\u9752\u84bf\u7425\u916f\u987a\u5229\u83b7\u5f97\u4e86WHO\u9884\u8ba4\u8bc1[16] \u3002MMV\u8fd8\u79ef\u6781\u63a8\u52a8\u4e86\u6ce8\u5c04\u7528\u9752\u84bf\u7425\u916f\u5728\u975e\u6d32\u56fd\u5bb6\u7684\u63a8\u5e7f\u548c\u4f7f\u7528\u3002<\/p>\n

2011\u5e74\uff0cWHO\u6307\u5357\u63a8\u8350\u5c06\u6ce8\u5c04\u7528\u9752\u84bf\u7425\u916f\u4f5c\u4e3a\u6cbb\u7597\u91cd\u75c7\u759f\u75be\u7684\u4e00\u7ebf\u7597\u6cd5\u3002\u622a\u81f32021\u5e74\uff0c\u6842\u6797\u5357\u836f\u751f\u4ea7\u7684\u6ce8\u5c04\u7528\u9752\u84bf\u7425\u916f\u5df2\u7d2f\u8ba1\u5411\u5168\u7403\u63d0\u4f9b\u8d852\u4ebf\u652f\uff0c\u662f\u5168\u7403\u6700\u5927\u7684\u6ce8\u5c04\u7528\u9752\u84bf\u7425\u916f\u4f9b\u5e94\u5546\uff0c\u633d\u6551\u4e86\u7ea64000\u4e07\u91cd\u75c7\u759f\u75be\u60a3\u8005\u751f\u547d\uff0c\u5176\u4e2d\u5927\u90e8\u5206\u662f5\u5c81\u4ee5\u4e0b\u975e\u6d32\u513f\u7ae5[17]\u3002<\/p>\n

\u201c\u770b\u5230\u6211\u4eec\u652f\u6301\u7684\u4ea7\u54c1\uff08\u6ce8\u5c04\u7528\u9752\u84bf\u7425\u916f\uff09\u80fd\u591f\u88ab\u4f7f\u7528\u5e76\u633d\u6551\u60a3\u513f\u751f\u547d\uff0c\u6211\u611f\u5230\u975e\u5e38\u6b23\u6170\u201d\uff0cMMV\u6ce8\u5c04\u7528\u9752\u84bf\u7425\u916f\u9879\u76ee\u8d1f\u8d23\u4eba\u76ae\u57c3\u5c14\u00b7\u96e8\u679c\u611f\u53f9\u9053[18]\u3002<\/p>\n

\u73b0\u5728\uff0c\u590d\u661f\u533b\u836f\u5df2\u6210\u4e3a\u5168\u7403\u57fa\u91d1\u7684\u4e3b\u8981\u4f9b\u5e94\u5546\u4e4b\u4e00\uff0c\u5176\u901a\u8fc7WHO\u9884\u8ba4\u8bc1\u7684\u4ea7\u54c1\u603b\u6570\u5df2\u589e\u81f330\u4e2a\uff0c\u5305\u62ec26\u4e2a\u5236\u5242\u548c4\u4e2a\u539f\u6599\u836f\uff0c\u836f\u54c1\u6db5\u76d6\u759f\u75be\u9884\u9632\u3001\u4e00\u822c\u759f\u75be\u6cbb\u7597\u548c\u91cd\u75c7\u759f\u75be\u62a2\u6551\u3002<\/p>\n

\u7528\u6297\u759f\u65b0\u7b56\u7565\u53bb\u5851\u9020\u65b0\u5e02\u573a\u00a0<\/strong><\/p>\n

2010\u5e74\u4e4b\u540e\uff0c\u968f\u7740\u56fd\u9645\u6297\u759f\u836f\u54c1\u516c\u7acb\u5e02\u573a\u4f9b\u5e94\u9010\u6e10\u9971\u548c \uff0c\u65b0\u73a9\u5bb6\u4eec\u60f3\u8981\u8fdb\u5165\u8fd9\u4e00\u5e02\u573a\u53d8\u5f97\u8d8a\u6765\u8d8a\u56f0\u96be\u3002<\/p>\n

\u902f\u6625\u660e\u53c2\u4e0e\u9886\u5bfc\u7684\u5e7f\u4e1c\u65b0\u5357\u65b9\u9752\u84bf\u836f\u4e1a\uff08\u4ee5\u4e0b\u7b80\u79f0\u65b0\u5357\u65b9\uff09\u51b3\u5b9a\u53e6\u8f9f\u8e4a\u5f84\uff0c\u4ece\u66f4\u4e3a\u5b8f\u89c2\u7684\u6297\u759f\u7b56\u7565\u5c42\u9762\u5165\u624b\uff0c\u8bd5\u56fe\u5728\u52a0\u901f\u6d88\u9664\u759f\u75be\u8fdb\u7a0b\u7684\u540c\u65f6\u6269\u5927\u65b0\u5357\u65b9\u6297\u759f\u836f\u54c1\u7684\u5e02\u573a\u4efd\u989d\u3002<\/p>\n

<\/p>\n

1999\u5e74\uff0c\u5f53\u65f6\u5728\u5317\u4eac\u5e02\u79d1\u6cf0\u65b0\u6280\u672f\u516c\u53f8\u8d1f\u8d23\u9752\u84bf\u7d20\u56fd\u9645\u5e02\u573a\u5f00\u62d3\u7684\u902f\u6625\u660e\uff0c\u6df1\u5165\u5c3c\u65e5\u5229\u4e9a\u4e0e\u4e4d\u5f97\u4ea4\u754c\u7684Borno\u5dde\u5e9cMaiduguri\u5f00\u5c55\u53cc\u6c22\u9752\u84bf\u7d20\uff08\u79d1\u6cf0\u65b0\uff09\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/p>\n

2000\u5e74\u4ee5\u6765\uff0c\u968f\u7740\u4e2d\u975e\u5408\u4f5c\u8bba\u575b\u7684\u4e3e\u884c\uff0c\u4e2d\u975e\u53cc\u8fb9\u63f4\u52a9\u9879\u76ee\u8d8a\u6765\u8d8a\u591a\uff0c\u902f\u6625\u660e\u4f5c\u4e3a\u4f01\u4e1a\u4ee3\u8868\u8ddf\u968f\u4e13\u5bb6\u56e2\u961f\u8d70\u8bbf\u4e86\u5c3c\u65e5\u5229\u4e9a\u3001\u4e4d\u5f97\u3001\u5580\u9ea6\u9686\u3001\u5766\u6851\u5c3c\u4e9a\u3001\u4e4c\u5e72\u8fbe\u7b49\u5341\u6570\u4e2a\u975e\u6d32\u56fd\u5bb6\uff0c\u5f00\u5c55\u57f9\u8bad\u9879\u76ee\u3001\u6297\u759f\u7269\u8d44\u63f4\u52a9\u3001\u6297\u759f\u4e2d\u5fc3\u5efa\u8bbe\u3002\u8fd9\u4e9b\u63f4\u5916\u9879\u76ee\u4ee4\u975e\u6d32\u66f4\u52a0\u4e86\u89e3\u9752\u84bf\u7d20\u4ea7\u54c1\uff0c\u5e2e\u52a9\u4e2d\u4f01\u5b9e\u73b0\u975e\u6d32\u5e02\u573a\u7684\u65e9\u671f\u7834\u51b0\u3002\u901a\u8fc7\u4e0e\u56fd\u5185\u5916\u4e13\u5bb6\u7684\u63a5\u89e6\uff0c\u902f\u6625\u660e\u4e5f\u4e86\u89e3\u5230\u4e2d\u56fd\u7684\u54ea\u4e9b\u7ecf\u9a8c\u548c\u6280\u672f\u4f18\u52bf\u80fd\u5e2e\u975e\u6d32\u56fd\u5bb6\u51cf\u8f7b\u759f\u75be\u8d1f\u62c5\uff0c\u4e3a\u4eca\u540e\u7684\u5e02\u573a\u5e03\u5c40\u57cb\u4e0b\u4f0f\u7b14\u3002<\/p>\n

\u4ed6\u8ba1\u5212\u5728\u73b0\u6709\u4ee5\u201c\u4e2a\u4f53\u6cbb\u7597\u201d\u4e3a\u4e3b\u7684\u516c\u7acb\u5e02\u573a\u4e2d\uff0c\u5f00\u521b\u4e00\u4e2a\u201c\u7fa4\u4f53\u670d\u836f\u201d\u5e02\u573a\uff0c\u5b9e\u65bd\u7fa4\u4f53\u670d\u836f\u7b56\u7565\uff0c\u8ba9\u65b0\u5357\u65b9\u7684\u65b0\u7ec4\u65b9\u4ea7\u54c1\u53d1\u6325\u914d\u65b9\u4f18\u52bf\uff0c\u633d\u6551\u66f4\u591a\u751f\u547d\u3002<\/p>\n

\u674e\u56fd\u6865\u662f\u6700\u65e9\u5728\u975e\u6d32\u56fd\u5bb6\u4f7f\u7528\u9752\u84bf\u7d20\u7c7b\u836f\u7269\u5f00\u5c55\u7fa4\u4f53\u670d\u836f\u7684\u4e13\u5bb6\u3002\u7fa4\u4f53\u670d\u836f\u6307\u901a\u8fc7\u7ed9\u759f\u75be\u6d41\u884c\u5730\u533a\u7684\u9ad8\u98ce\u9669\u4eba\u7fa4\u670d\u7528\u6297\u759f\u836f\uff0c\u6765\u5feb\u901f\u964d\u4f4e\u5f53\u5730\u759f\u75be\u6d41\u884c\u7a0b\u5ea6\uff0c\u8fd9\u4e00\u7b56\u7565\u7684\u6709\u6548\u6027\u5728\u4e2d\u56fd\u6d88\u9664\u759f\u75be\u8fc7\u7a0b\u4e2d\u5df2\u7ecf\u5728\u5b89\u5fbd\u3001\u6cb3\u5357\u7b49\u5730\u5f97\u5230\u9a8c\u8bc1\u30022007\u5e74\uff0c\u7531\u674e\u56fd\u6865\u548c\u5b8b\u5065\u5e73\u5e26\u9886\u7684\u5e7f\u5dde\u4e2d\u533b\u836f\u5927\u5b66\u5728\u975e\u6d32\u79d1\u6469\u7f57\u7684\u83ab\u57c3\u5229\u5c9b\uff08Moh\u00e9li\uff09\u542f\u52a8\u4e86\u4ee5\u8be5\u7b56\u7565\u4e3a\u6838\u5fc3\u7684\u6297\u759f\u9879\u76ee\uff0c\u4f7f\u7528\u65b0\u5357\u65b9\u751f\u4ea7\u7684\u9752\u84bf\u7d20\u54cc\u55b9\u7247\u4f5c\u4e3a\u5e72\u9884\u836f\u54c1\u3002\u76f4\u52302014\u5e74\u9879\u76ee\u8986\u76d6\u79d1\u6469\u7f57\u5168\u5883\uff0c\u4ec5\u75287\u5e74\u65f6\u95f4\uff0c\u6240\u6709\u5e72\u9884\u5730\u533a\u5747\u5b9e\u73b0\u4e86\u96f6\u759f\u75be\u6b7b\u4ea1\u75c5\u4f8b\uff0c\u759f\u75be\u611f\u67d3\u7387\u4e5f\u4ece\u6bcf\u5343\u4eba\u53e3142\u4f8b\u4e0b\u964d\u81f32.8\u4f8b\u3002<\/p>\n

\u8fd9\u4e00\u6210\u679c\u4e5f\u5f15\u8d77\u4e86WHO\u7684\u5173\u6ce8\u30022014\u5e74\uff0cWHO\u5728\u585e\u62c9\u5229\u6602\u5f00\u5c55\u4e86\u4e3a\u671f5\u5468\u7684\u7fa4\u4f53\u670d\u836f\u5e72\u9884\uff0c\u7ed3\u679c\u53d1\u73b0\u5f53\u5730\u759f\u75be\u53d1\u75c5\u7387\u663e\u8457\u4e0b\u964d\u4e86\u8d85\u8fc740%[19]\u3002\u8fd9\u6781\u5927\u589e\u5f3a\u4e86WHO\u5bf9\u7fa4\u4f53\u670d\u836f\u7b56\u7565\u7684\u4fe1\u5fc3\u3002\u968f\u77402015\u5e74\u540e\u5168\u7403\u759f\u75be\u75c5\u4f8b\u6570\u4e0b\u964d\u8d8b\u52bf\u51cf\u7f13\uff0c\u759f\u9632\u5de5\u4f5c\u9047\u5230\u74f6\u9888\uff0cWHO\u610f\u8bc6\u5230\u4ec5\u9760\u4f20\u7edf\u9632\u63a7\u624b\u6bb5\u96be\u4ee5\u5b9e\u73b02030\u76ee\u6807\uff0c\u8feb\u5207\u9700\u8981\u521b\u65b0\u6709\u6548\u7684\u65b0\u7b56\u7565\u3001\u65b9\u6cd5\u548c\u5de5\u5177\u30022017\u5e74\uff0cWHO\u6b63\u5f0f\u63a8\u8350\u7fa4\u4f53\u670d\u836f\u4e3a\u63a7\u5236\u6076\u6027\u759f\u6d41\u884c\u7684\u6709\u6548\u624b\u6bb5[20]\u3002<\/p>\n

<\/p>\n

2014\u5e74\uff0c\u975e\u6d32\u56fd\u5bb6\u79d1\u6469\u7f57\u8054\u76df\u526f\u603b\u7edf\u517c\u536b\u751f\u90e8\u957f\uff08\u4e2d\uff09\u4e3a\u5e7f\u5dde\u4e2d\u533b\u836f\u5927\u5b66\u7684\u674e\u56fd\u6865\uff08\u53f3\u4e00\uff09\u548c\u5b8b\u5efa\u5e73\uff08\u5de6\u4e00\uff09\u9881\u5956\uff0c\u8868\u5f70\u4ed6\u4eec\u5e26\u9886\u7684\u56e2\u961f\u5728\u5feb\u901f\u706d\u6e90\u706d\u759f\u5de5\u4f5c\u4e2d\u7684\u7a81\u51fa\u8d21\u732e\u3002<\/p>\n

\u5c3d\u7ba1\u9752\u84bf\u7d20-\u54cc\u55b9\u5df2\u7ecf\u5728\u79d1\u6469\u7f57\u548c\u5df4\u5e03\u4e9a\u65b0\u51e0\u5185\u4e9a\u7b49\u5730\u7684\u6297\u759f\u9879\u76ee\u4e2d\u201c\u5927\u663e\u795e\u901a\u201d\uff0c\u4f46\u7531\u4e8e\u8be5\u836f\u672a\u7533\u8bf7WHO\u9884\u8ba4\u8bc1\uff0c\u5f15\u53d1\u4e86\u56fd\u9645\u793e\u4f1a\u5bf9\u836f\u7269\u5b89\u5168\u6027\u7684\u8d28\u7591\u3002\u591a\u5e74\u7684\u56fd\u9645\u5e02\u573a\u63a8\u5e7f\u7ecf\u5386\uff0c\u4ee4\u902f\u6625\u660e\u7406\u89e3WHO\u9884\u8ba4\u8bc1\u7684\u91cd\u8981\u6027\u30022017-18\u5e74\uff0c\u4ed6\u5e26\u9886\u65b0\u5357\u65b9\u56e2\u961f\uff0c\u53ec\u96c6WHO\u3001\u76d6\u8328\u57fa\u91d1\u4f1a\u3001\u5317\u4eac\u5927\u5b66\u7b49\u673a\u6784\u7684\u759f\u75be\u4e13\u5bb6\uff0c\u5f00\u5c55\u591a\u8f6e\u6280\u672f\u7814\u8ba8\u548c\u8bba\u8bc1\u4f1a\uff0c\u5728\u5927\u91cf\u7684\u8d44\u6599\u548c\u5b9e\u8bc1\u6570\u636e\u7684\u57fa\u7840\u4e0a\uff0c\u5404\u65b9\u8fbe\u6210\u4e00\u81f4\uff1a\u5c06\u539f\u7ec4\u65b9\u4e2d\u7684\u9752\u84bf\u7d20\u8fdb\u884c\u66ff\u6362\uff0c\u7528\u65b0\u7684\u7ec4\u65b9\u7533\u8bf7WHO\u9884\u8ba4\u8bc1\u3002\u6b64\u524d\uff0c\u6240\u6709\u7533\u8bf7WHO\u9884\u8ba4\u8bc1\u7684\u836f\u54c1\u5fc5\u987b\u9996\u5148\u901a\u8fc7\u7f8e\u56fd\u3001\u6b27\u76df\u7b49\u4e25\u683c\u836f\u54c1\u76d1\u7ba1\u673a\u6784\uff08Stringent Regulatory Authority\uff0cSRA\uff09\u8ba4\u8bc1\uff0c\u800c\u65b0\u7684\u7ec4\u65b9\u4f5c\u4e3a\u539f\u7814\u836f\u672a\u901a\u8fc7SRA\u673a\u6784\u8ba4\u8bc1\uff0c\u8fd9\u4e5f\u5f00\u521b\u4e86\u539f\u7814\u836f\u76f4\u63a5\u7533\u8bf7WHO\u9884\u8ba4\u8bc1\u7684\u5148\u4f8b\u3002<\/p>\n

\u76ee\u524d\uff0c\u65b0\u5357\u65b9\u7684WHO\u9884\u8ba4\u8bc1\u9879\u76ee\u4ecd\u5728\u7a33\u6b65\u63a8\u8fdb\u8fc7\u7a0b\u4e2d\uff0c\u6216\u9700\u6570\u5e74\u65f6\u95f4\u624d\u80fd\u6210\u529f\u3002\u4f46\u8fd9\u53ea\u662f\u4ed6\u4eec\u5e03\u5c40\u7684\u5f00\u7aef\u3002\u76f8\u6bd4\u4ec5\u9760WHO\u9884\u8ba4\u8bc1\u89e3\u51b3\u4ea7\u54c1\u8d28\u91cf\u95ee\u9898\uff0c\u5728\u73b0\u6709\u5e02\u573a\u7a7a\u95f4\u4e2d\u7ade\u4e89\u640f\u6740\uff0c\u902f\u6625\u660e\u5e0c\u671b\u63a2\u7d22\u4e00\u6761\u201c\u53cc\u8d62\u201d\u8def\u5f84\uff0c\u65e2\u80fd\u53d1\u6325\u4ea7\u54c1\u4f18\u52bf\uff0c\u6539\u5584\u5f53\u524d\u5168\u7403\u505c\u6ede\u4e0d\u524d\u7684\u6297\u759f\u5f62\u52bf\uff0c\u540c\u65f6\u4e5f\u80fd\u62d3\u5bbd\u5e02\u573a\u5bb9\u91cf\uff0c\u8ba9\u4e2d\u56fd\u7684\u9752\u84bf\u7d20\u4ea7\u54c1\u901a\u8fc7\u65b0\u7684\u201c\u7fa4\u4f53\u670d\u836f\u201d\u5e02\u573a\u5360\u636e\u4e00\u5e2d\u4e4b\u5730\u3002<\/p>\n

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