{"id":42708,"date":"2024-10-24T05:10:45","date_gmt":"2024-10-24T05:10:45","guid":{"rendered":"https:\/\/zydq.1006ss.com\/?p=42708"},"modified":"2024-10-24T05:10:45","modified_gmt":"2024-10-24T05:10:45","slug":"%e4%b8%80%e6%96%87%e7%90%86%e6%b8%85ec%e3%80%81ema%e3%80%81hma-nca%e5%8f%8aedqm%e5%9c%a8%e6%ac%a7%e6%b4%b2%e8%8d%af%e5%93%81%e6%b3%a8%e5%86%8c%e4%b8%ad%e7%9a%84%e8%81%8c%e8%83%bd%e5%92%8c%e5%85%b3","status":"publish","type":"post","link":"http:\/\/zydq.1006ss.com\/?p=42708","title":{"rendered":"\u4e00\u6587\u7406\u6e05EC\u3001EMA\u3001HMA, NCA\u53caEDQM\u5728\u6b27\u6d32\u836f\u54c1\u6ce8\u518c\u4e2d\u7684\u804c\u80fd\u548c\u5173\u7cfb"},"content":{"rendered":"

\u4e00\u6587\u7406\u6e05EC\u3001EMA\u3001HMA, NCA\u53caEDQM\u5728\u6b27\u6d32\u836f\u54c1\u6ce8\u518c\u4e2d\u7684\u804c\u80fd\u548c\u5173\u7cfb<\/p>\n<\/h2>\n

2022-07-18 16:24<\/p>\n

\u6b27\u6d32\u4f5c\u4e3a\u836f\u54c1\u6d88\u8d39\u4e3b\u6d41\u5e02\u573a\u4e4b\u4e00\uff0c\u83b7\u5f97\u6b27\u6d32\u836f\u54c1\u4e0a\u5e02\u8bb8\u53ef\uff0c\u5bf9\u4e8e\u4e2d\u56fd\u4f01\u4e1a\u610f\u4e49\u91cd\u5927\u3002\u8fd1\u671f\uff0c\u79d1\u5a01\u5229\u534e\u5c06\u9646\u7eed\u5bf9\u6b27\u6d32\u836f\u54c1\u7533\u62a5\u7ba1\u7406\u5236\u5ea6\u8fdb\u884c\u5168\u65b9\u4f4d\u4ecb\u7ecd\uff0c\u656c\u8bf7\u5173\u6ce8\u3002\u672c\u671f\uff0c\u7b14\u8005\u5c06\u7740\u91cd\u4ecb\u7ecd\u6b27\u6d32\u836f\u54c1\u76d1\u7ba1\u673a\u6784\uff0c\u5305\u62ec\u6b27\u76df\u59d4\u5458\u4f1a\uff08EC\uff09\u3001\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u3001\u56fd\u5bb6\u4e3b\u7ba1\u5f53\u5c40\uff08NCA\uff09\u3001\u836f\u54c1\u5c40\u603b\u90e8\uff08HMA\uff09\u4ee5\u53ca\u6b27\u6d32\u836f\u54c1\u8d28\u91cf\u7ba1\u7406\u5c40\uff08EDQM\uff09\u3002<\/p>\n

1. \u524d\u8a00<\/h2>\n

\u5728\u4ecb\u7ecd\u6b27\u6d32\u836f\u54c1\u76d1\u7ba1\u673a\u6784\u4e4b\u524d\uff0c\u6211\u4eec\u5148\u6765\u4e86\u89e3\u6b27\u6d32\u7684\u4e24\u4e2a\u56fd\u9645\u7ec4\u7ec7\uff0c\u5373\u6b27\u6d32\u8054\u76df\uff08\u7b80\u79f0\u6b27\u76df\uff0cEuropean Union\uff09\u548c\u6b27\u6d32\u59d4\u5458\u4f1a\uff08Council of Europe\uff09\u3002\u9700\u8981\u5f3a\u8c03\u7684\u662f\u6b27\u6d32\u59d4\u5458\u4f1a\u4e0d\u662f\u5c5e\u4e8e\u6b27\u76df\u7684\u673a\u6784\uff0c\u800c\u662f\u548c\u6b27\u76df\u4e00\u6837\uff0c\u662f\u4e00\u4e2a\u56fd\u9645\u7ec4\u7ec7\uff0c\u5176\u81f4\u529b\u4e8e\u5b9e\u73b0\u6574\u4e2a\u6b27\u6d32\u5927\u9646\u53ca\u5176\u4ed6\u5730\u533a\u5b89\u5168\u836f\u7269\u8d28\u91cf\u6807\u51c6\u7684\u7edf\u4e00\u3002\u800c\u6b27\u76df\u836f\u54c1\u76d1\u7ba1\u4f53\u7cfb\u662f\u4e00\u4e2a\u7531\u6765\u81ea\u6b27\u6d32\u7ecf\u6d4e\u533a\u768430\u4e2a\u56fd\u5bb6\uff08\u5305\u62ec27\u4e2a\u6b27\u76df\u6210\u5458\u56fd\u548c3\u4e2a\u6b27\u6d32\u7ecf\u6d4e\u533a\u56fd\u5bb6\u51b0\u5c9b\u3001\u5217\u652f\u6566\u58eb\u767b\u53ca\u632a\u5a01\uff09\u7684\u7ea6\u51e0\u5341\u4e2a\u836f\u54c1\u76d1\u7ba1\u673a\u6784\u3001\u6b27\u76df\u59d4\u5458\u4f1a\u548cEMA\u6784\u6210\u7684\u7f51\u7edc\uff0c\u8fd9\u4e2a\u7f51\u7edc\u6b63\u662f\u6b27\u76df\u76d1\u7ba1\u4f53\u7cfb\u72ec\u7279\u6240\u5728\u3002<\/p>\n

\u6b27\u76df\u548c\u6b27\u6d32\u59d4\u5458\u4f1a\u5bf9\u6bd4\u5982\u4e0b\uff1a<\/p>\n<\/p>\n

2. \u6b27\u76df\u59d4\u5458\u4f1a\uff08EC\uff09<\/p>\n

\u6b27\u76df\u59d4\u5458\u4f1a\uff08European Commission\uff0cEC\uff09\u4f5c\u4e3a\u6b27\u76df\u7684\u884c\u653f\u673a\u6784\uff0c\u5927\u81f4\u76f8\u5f53\u4e8e\u4e00\u4e2a\u56fd\u5bb6\u7cfb\u7edf\u5f53\u4e2d\u7684\u653f\u5e9c\uff0c\u8d1f\u8d23\u7ef4\u62a4\u6b27\u76df\u6761\u7ea6\u548c\u7ba1\u7406\u65e5\u5e38\u4e8b\u52a1\uff0c\u5236\u5b9a\u6b27\u76df\u5e74\u5ea6\u9884\u7b97\u548c\u76f8\u5e94\u76d1\u7763\u5de5\u4f5c\uff0c\u8fd8\u662f\u6b27\u76df\u7acb\u6cd5\u7684\u552f\u4e00\u53d1\u8d77\u8005\u3002<\/p>\n

\u6b27\u76df\u59d4\u5458\u4f1a\u5bf9\u6b27\u76df\u836f\u54c1\u76d1\u7ba1\u6709\u7740\u975e\u5e38\u91cd\u8981\u7684\u4f5c\u7528\uff1a<\/p>\n

– \u5728EMA\u8fdb\u884c\u7684\u79d1\u5b66\u8bc4\u5ba1\u7684\u57fa\u7840\u4e0a\uff0c\u6b27\u76df\u59d4\u5458\u4f1a\u6279\u51c6\u3001\u62d2\u7edd\u6216\u6682\u505c\u901a\u8fc7\u96c6\u4e2d\u7a0b\u5e8f\u9012\u4ea4\u7684\u4e0a\u5e02\u7533\u8bf7\uff1b<\/p>\n

– \u5f53\u67d0\u4e2a\u83b7\u5f97\u6210\u5458\u56fd\u4e0a\u5e02\u6279\u51c6\u7684\u836f\u54c1\u51fa\u73b0\u5b89\u5168\u95ee\u9898\uff0c\u7ecfEMA\u836f\u7269\u8b66\u6212\u98ce\u9669\u8bc4\u4ef7\u59d4\u5458\u4f1a\uff08PRAC\uff09\u7684\u8bc4\u4ef7\u8ba4\u5b9a\u5728\u6240\u6709\u6210\u5458\u56fd\u90fd\u6709\u5fc5\u8981\u91c7\u53d6\u534f\u8c03\u76d1\u7ba1\u63aa\u65bd\u65f6\uff0c\u6b27\u76df\u59d4\u5458\u4f1a\u53ef\u4ee5\u5728\u6b27\u6d32\u8303\u56f4\u5185\u91c7\u53d6\u76f8\u5e94\u63aa\u65bd\uff1b<\/p>\n

– \u6b27\u76df\u59d4\u5458\u4f1a\u4e5f\u53ef\u4ee5\u5728\u63d0\u8bae\u65b0\u7684\u836f\u7269\u6cd5\u89c4\u6216\u4fee\u6539\u73b0\u6709\u6cd5\u89c4\u65b9\u9762\u53d1\u6325\u4f5c\u7528\u3002<\/p>\n

3. \u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09<\/h2>\n

\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08European Medicine Agency\uff0cEMA\uff09\uff0c\u524d\u8eab\u4e3a1993\u5e74\u5efa\u7acb\u7684\u6b27\u6d32\u836f\u54c1\u8bc4\u4ef7\u5c40\uff08European Medicine Evaluation Agency, EMEA\uff09\uff0c\u539f\u603b\u90e8\u5728\u82f1\u56fd\u4f26\u6566\uff0c\u73b0\u5728\u642c\u8fc1\u81f3\u8377\u5170\u963f\u59c6\u65af\u7279\u4e39\u3002EMA\u4e0b\u8bbe7\u4e2a\u79d1\u5b66\u59d4\u5458\u4f1a\uff08\u89c1\u4e0b\u56fe\uff09\uff0c\u8d1f\u8d23\u5bf9\u5236\u836f\u516c\u53f8\u63d0\u4ea4\u7684\u836f\u54c1\u7533\u8bf7\u8fdb\u884c\u79d1\u5b66\u8bc4\u4f30\u3002<\/p>\n<\/p>\n

\u5176\u4e2d\uff0c\u6700\u4e3a\u719f\u6089\u7684\u662f\u4eba\u7528\u836f\u54c1\u59d4\u5458\u4f1a\uff08CHMP\uff09\uff0c\u5176\u8d1f\u8d23\u6b27\u76df\u5e02\u573a\u836f\u54c1\u7533\u8bf7\u96c6\u4e2d\u7a0b\u5e8f\uff08CP\uff09\u7684\u5ba1\u8bc4\uff1b\u540c\u65f6\uff0c\u5f53\u5206\u6563\u5ba1\u8bc4\u7a0b\u5e8f\uff08DCP\uff09\u548c\u4e92\u8ba4\u7a0b\u5e8f\uff08MRP\uff09\u51fa\u73b0\u6210\u5458\u56fd\u610f\u89c1\u4e0d\u4e00\u81f4\u65f6\uff0c\u7531CHMP\u8d1f\u8d23\u534f\u8c03\u3002 <\/p>\n

EMA\u4e3a\u6574\u4e2a\u6b27\u76df\u836f\u54c1\u76d1\u7ba1\u7684\u6700\u9ad8\u673a\u6784\uff0c\u7531\u5404\u6210\u5458\u56fd\u4ee3\u8868\u5145\u5f53EMA\u59d4\u5458\u4f1a\u7684\u6210\u5458\uff0c\u5176\u4e3b\u8981\u804c\u80fd\u662f\uff1a<\/p>\n

– \u8d1f\u8d23\u6b27\u76df\u5e02\u573a\u836f\u54c1\u7533\u8bf7\u96c6\u4e2d\u7a0b\u5e8f\uff08CP\uff09\u7684\u5ba1\u8bc4\uff0c\u8bc4\u4f30\u836f\u54c1\u79d1\u5b66\u7814\u7a76\uff0c\u76d1\u7763\u836f\u54c1\u5728\u6b27\u76df\u7684\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\uff1b<\/p>\n

– \u8d1f\u8d23\u534f\u8c03\u3001\u68c0\u67e5\u3001\u76d1\u7763\u5404\u6210\u5458\u56fd\u7684GXP\u68c0\u67e5\uff0c\u5305\u62ecGAP\u3001GMP\u3001GLP\u3001GCP\u3001GDP\u7b49\uff1b<\/p>\n

– \u89e3\u51b3\u7ea0\u7eb7\uff0c\u534f\u8c03\u9012\u4ea4\u5230\u59d4\u5458\u4f1a\u7684\u836f\u54c1\u79d1\u5b66\u8bc4\u4ef7\u610f\u89c1\uff0c\u5e76\u5728\u6b27\u76df\u5185\u90e8\u4fc3\u8fdb\u79d1\u5b66\u6280\u672f\u7684\u521b\u65b0\u3001\u53d1\u5c55\u548c\u4ea4\u6d41\u3002<\/p>\n

4. \u56fd\u5bb6\u4e3b\u7ba1\u5f53\u5c40\uff08NCA\uff09<\/h2>\n

\u9664\u4e86\u6b27\u76df\u5c42\u9762\u5bf9\u836f\u54c1\u4e0a\u5e02\u7533\u8bf7\u7684\u5ba1\u6279\u53ca\u5bf9\u836f\u54c1\u8d28\u91cf\u7684\u76d1\u7ba1\u8fdb\u884c\u7edf\u4e00\u7ec4\u7ec7\u534f\u8c03\u5916\uff0c\u6b27\u76df\u5404\u6210\u5458\u56fd\u4e5f\u5747\u6709\u5404\u81ea\u7684\u56fd\u5bb6\u4e3b\u7ba1\u5f53\u5c40\uff08National Competent Authority, NCA\uff09\uff0c\u5176\u4e3b\u8981\u804c\u80fd\u6709\uff1a<\/p>\n

– \u8d1f\u8d23\u5ba1\u6279\u56fd\u5bb6\u7a0b\u5e8f\uff08NP\uff09\u7684\u836f\u54c1\u4e0a\u5e02\u7533\u8bf7\uff1b<\/p>\n

– \u4f5c\u4e3a\u4e3b\u5ba1\u56fd\u6216\u53c2\u5ba1\u56fd\u53c2\u4e0e\u5206\u6563\u5ba1\u8bc4\u7a0b\u5e8f\uff08DCP\uff09\u7684\u836f\u54c1\u4e0a\u5e02\u7533\u8bf7\u5ba1\u6279\uff1b<\/p>\n

– \u8d1f\u8d23\u836f\u7269\u5b89\u5168\u76d1\u63a7\uff1b<\/p>\n

– \u6267\u884cGXP\u68c0\u67e5\u3002<\/p>\n

5. \u836f\u54c1\u5c40\u603b\u90e8\uff08HMA\uff09<\/h2>\n

\u836f\u54c1\u5c40\u603b\u90e8\uff08Heads of Medicines Agencies, HMA\uff09\u662f\u7531\u56fd\u5bb6\u4e3b\u7ba1\u5f53\u5c40\uff08NCA\uff09\u8d1f\u8d23\u4eba\u7ec4\u6210\uff0c\u4e0e\u6b27\u76df\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u548c\u6b27\u76df\u59d4\u5458\u4f1a\uff08EC\uff09\u5408\u4f5c\u8fd0\u8425\u6b27\u76df\u836f\u54c1\u76d1\u7ba1\u7f51\u7edc\u3002<\/p>\n

HMA\u7531\u4e00\u4e2a\u7ba1\u7406\u7ec4\u534f\u8c03\u548c\u76d1\u7763\uff0c\u5e76\u5f97\u5230\u591a\u4e2a\u5de5\u4f5c\u7ec4\u53ca\u5e38\u8bbe\u79d8\u4e66\u5904\u7684\u652f\u6301\uff0c\u8d1f\u8d23\u6b27\u6d32\u7ecf\u6d4e\u533a\u4eba\u7528\u548c\u517d\u7528\u836f\u54c1\u7684\u76d1\u7ba1\uff0c\u5e76\u5728\u4eba\u7528\u548c\u517d\u7528\u836f\u54c1\u76d1\u7ba1\u9886\u57df\u5206\u522b\u8bbe\u7acb\u4e86\u534f\u8c03\u7ec4\u7ec7\uff0c\u5206\u522b\u4e3a\u4eba\u7528\u836f\u4e92\u8ba4\u7a0b\u5e8f\u548c\u5206\u6563\u5ba1\u8bc4\u7a0b\u5e8f\u534f\u8c03\u7ec4\uff08CMDh\uff09\u548c\u517d\u836f\u4e92\u8ba4\u7a0b\u5e8f\u548c\u5206\u6563\u5ba1\u8bc4\u7a0b\u5e8f\u534f\u8c03\u7ec4\uff08CMDv\uff09\uff0c\u4e3b\u8981\u8d1f\u8d23\u5ba1\u67e5\u548c\u534f\u8c03\u5728\u4e92\u8ba4\u7a0b\u5e8f\u548c\u5206\u6563\u5ba1\u8bc4\u7a0b\u5e8f\u4e2d\u4e0e\u4e24\u4e2a\u6216\u591a\u4e2a\u6210\u5458\u56fd\u7684\u836f\u54c1\u4e0a\u5e02\u8bb8\u53ef\u6709\u5173\u7684\u95ee\u9898\u3002<\/p>\n

\u7b80\u800c\u8a00\u4e4b\uff0cHMA\u7684\u804c\u80fd\u4e3b\u8981\u6709\uff1a<\/p>\n

– \u89e3\u51b3\u6b27\u76df\u836f\u54c1\u76d1\u7ba1\u7f51\u7edc\u7684\u5173\u952e\u6218\u7565\u95ee\u9898\uff0c\u4f8b\u5982\u4fe1\u606f\u4ea4\u6d41\u3001IT\u53d1\u5c55\u548c\u6700\u4f73\u5b9e\u8df5\u5171\u4eab\uff1b<\/p>\n

– \u4e13\u6ce8\u4e8e\u6b27\u76df\u836f\u54c1\u76d1\u7ba1\u4f53\u7cfb\u7684\u5f00\u53d1\u3001\u534f\u8c03\u548c\u4e00\u81f4\u6027\uff1b<\/p>\n

– \u786e\u4fdd\u6700\u6709\u6548\u548c\u9ad8\u6548\u5730\u4f7f\u7528\u6574\u4e2a\u6b27\u76df\u836f\u54c1\u76d1\u7ba1\u7f51\u7edc\u7684\u8d44\u6e90\uff0c\u5305\u62ec\u5236\u5b9a\u548c\u76d1\u7763\u5de5\u4f5c\u5171\u4eab\u5b89\u6392\uff1b<\/p>\n

– \u534f\u8c03\u4e92\u8ba4\u7a0b\u5e8f\uff08MRP\uff09\u548c\u5206\u6563\u5ba1\u8bc4\u7a0b\u5e8f\uff08DCP\uff09\u3002<\/p>\n

6. \u6b27\u6d32\u836f\u54c1\u8d28\u91cf\u7ba1\u7406\u5c40\uff08EDQM\uff09<\/h2>\n

\u6b27\u6d32\u836f\u54c1\u8d28\u91cf\u7ba1\u7406\u5c40\uff08European directorate for quality of medicines and health care, EDQM\uff09\uff0c\u5176\u521b\u7acb\u4e8e1964\u5e74\uff0c\u539f\u540d\u79f0\u4e3a\u201cEuropean Pharmacopoeia Secretariat\u201d\uff0c\u96b6\u5c5e\u4e8e1949\u5e74\u521b\u7acb\u7684\u6b27\u6d32\u59d4\u5458\u4f1a\uff08Council of Europe\uff09\uff0c1996\u5e74\u7ecf\u6b27\u5171\u4f53\u4e0e\u6b27\u6d32\u8bae\u4f1a\u534f\u5546\u540e\uff0c\u4ee5\u8bbe\u5728\u6cd5\u56fd\u7684\u6b27\u6d32\u836f\u5178\u59d4\u5458\u4f1a\u79d8\u4e66\u5904\u4e3a\u57fa\u7840\u6210\u7acb\u4e86\u6b27\u6d32\u836f\u54c1\u8d28\u91cf\u7ba1\u7406\u5c40\uff08EDQM\uff09\u3002<\/p>\n

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EDQM\u5177\u4f53\u804c\u80fd\u4e3b\u8981\u6709\uff1a<\/p>\n

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7. \u7ed3\u8bed<\/h2>\n

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\u4e00\u6587\u7406\u6e05EC\u3001EMA\u3001HMA, NCA\u53caEDQM\u5728\u6b27\u6d32\u836f\u54c1\u6ce8\u518c\u4e2d\u7684\u804c\u80fd\u548c\u5173\u7cfb 2 … \u7ee7\u7eed\u9605\u8bfb →<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[70],"tags":[],"class_list":["post-42708","post","type-post","status-publish","format-standard","hentry","category-70"],"_links":{"self":[{"href":"http:\/\/zydq.1006ss.com\/index.php?rest_route=\/wp\/v2\/posts\/42708","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/zydq.1006ss.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/zydq.1006ss.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/zydq.1006ss.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/zydq.1006ss.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=42708"}],"version-history":[{"count":0,"href":"http:\/\/zydq.1006ss.com\/index.php?rest_route=\/wp\/v2\/posts\/42708\/revisions"}],"wp:attachment":[{"href":"http:\/\/zydq.1006ss.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=42708"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/zydq.1006ss.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=42708"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/zydq.1006ss.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=42708"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}