{"id":4133,"date":"2025-09-04T13:58:09","date_gmt":"2025-09-04T05:58:09","guid":{"rendered":"https:\/\/rohs.ac.cn\/?p=4133"},"modified":"2025-09-04T13:58:09","modified_gmt":"2025-09-04T05:58:09","slug":"%e4%b8%89%e7%b1%bb%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e6%80%8e%e4%b9%88%e5%8a%9e%e7%90%86","status":"publish","type":"post","link":"https:\/\/rohs.ac.cn\/?p=4133","title":{"rendered":"\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u600e\u4e48\u529e\u7406"},"content":{"rendered":"

\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u600e\u4e48\u529e\u7406\u662f\u8bb8\u591a\u533b\u7597\u5668\u68b0\u751f\u4ea7\u4e0e\u7ecf\u8425\u4f01\u4e1a\u9ad8\u5ea6\u5173\u6ce8\u7684\u6838\u5fc3\u95ee\u9898\uff0c\u4f5c\u4e3a\u533b\u7597\u5668\u68b0\u5206\u7c7b\u4e2d\u98ce\u9669\u7b49\u7ea7\u6700\u9ad8\u3001\u76d1\u7ba1\u6700\u4e3a\u4e25\u683c\u7684\u7c7b\u522b\uff0c\u5176\u6ce8\u518c\u4e0e\u5907\u6848\u6d41\u7a0b\u4e0d\u4ec5\u73af\u8282\u590d\u6742\u3001\u5468\u671f\u957f\uff0c\u800c\u4e14\u8981\u6c42\u7533\u62a5\u4e3b\u4f53\u5177\u5907\u624e\u5b9e\u7684\u4e13\u4e1a\u77e5\u8bc6\u548c\u5145\u5206\u7684\u8d44\u6e90\u51c6\u5907\u3002<\/p>\n<\/p>\n

\u672c\u6587\u5c06\u7cfb\u7edf\u6027\u5730\u89e3\u6790\u5728\u4e2d\u56fd\u5883\u5185\u529e\u7406\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7684\u5168\u6d41\u7a0b\u3001\u5173\u952e\u73af\u8282\u4e0e\u5e38\u89c1\u96be\u70b9\uff0c\u4e3a\u76f8\u5173\u4f01\u4e1a\u63d0\u4f9b\u6e05\u6670\u3001\u5b9e\u7528\u7684\u64cd\u4f5c\u6307\u5357\uff0c\u52a9\u529b\u4ea7\u54c1\u5408\u89c4\u4e0a\u5e02\u3002<\/p>\n<\/p>\n

\u4e00\u3001 \u8ba4\u8bc6\u4e09\u7c7b\u533b\u7597\u5668\u68b0\uff1a\u4e3a\u4f55\u529e\u7406\u6d41\u7a0b\u5982\u6b64\u4e25\u683c\uff1f<\/strong><\/p>\n

\u5728\u6df1\u5165\u63a2\u8ba8\u201c\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u600e\u4e48\u529e\u7406\u201d\u4e4b\u524d\uff0c\u9996\u5148\u9700\u660e\u786e\u5176\u5b9a\u4e49\u4e0e\u76d1\u7ba1\u80cc\u666f\u3002<\/p>\n

\u6839\u636e\u300a\u533b\u7597\u5668\u68b0\u76d1\u7763\u7ba1\u7406\u6761\u4f8b\u300b\uff0c\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u662f\u6307\u690d\u5165\u4eba\u4f53\uff0c\u7528\u4e8e\u652f\u6301\u3001\u7ef4\u6301\u751f\u547d\uff0c\u6216\u5bf9\u4eba\u4f53\u5177\u6709\u6f5c\u5728\u5371\u9669\uff0c\u5fc5\u987b\u4e25\u683c\u63a7\u5236\u5176\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u7684\u533b\u7597\u5668\u68b0\u3002<\/p>\n<\/p>\n

\u5e38\u89c1\u7684\u4ea7\u54c1\u5305\u62ec\u5fc3\u810f\u8d77\u640f\u5668\u3001\u4eba\u5de5\u5173\u8282\u3001\u8840\u7ba1\u652f\u67b6\u3001\u690d\u5165\u6027\u836f\u7269\u91ca\u653e\u7cfb\u7edf\u7b49\u3002<\/p>\n<\/p>\n

\u7531\u4e8e\u5176\u76f4\u63a5\u5173\u7cfb\u5230\u4f7f\u7528\u8005\u7684\u751f\u547d\u5065\u5eb7\uff0c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u5bf9\u5176\u91c7\u53d6\u6700\u4e25\u683c\u7684\u4e0a\u5e02\u524d\u5ba1\u6279\u5236\u5ea6\uff0c\u786e\u4fdd\u5176\u98ce\u9669\u53ef\u63a7\u3001\u7597\u6548\u786e\u51ff\u3002<\/p>\n<\/p>\n

\u4e8c\u3001 \u4e09\u7c7b\u533b\u7597\u5668\u68b0\u6ce8\u518c\u529e\u7406\u5168\u6d41\u7a0b\u6838\u5fc3\u6b65\u9aa4\u89e3\u6790<\/strong><\/p>\n

\u529e\u7406\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u6ce8\u518c\u662f\u4e00\u4e2a\u7cfb\u7edf\u6027\u5de5\u7a0b\uff0c\u4e3b\u8981\u53ef\u5206\u4e3a\u4ee5\u4e0b\u51e0\u4e2a\u5173\u952e\u9636\u6bb5\uff1a<\/p>\n<\/p>\n

1. \u524d\u671f\u51c6\u5907\u4e0e\u4ea7\u54c1\u5b9a\u6027<\/strong><\/p>\n

\u7b2c\u4e00\u6b65\u662f\u786e\u8ba4\u4ea7\u54c1\u662f\u5426\u5c5e\u4e8e\u533b\u7597\u5668\u68b0\uff0c\u5e76\u51c6\u786e\u5224\u5b9a\u5176\u7ba1\u7406\u7c7b\u522b\u3002<\/p>\n<\/p>\n

\u4f01\u4e1a\u9700\u53c2\u8003\u300a\u533b\u7597\u5668\u68b0\u5206\u7c7b\u76ee\u5f55\u300b\u6216\u7533\u8bf7\u5206\u7c7b\u754c\u5b9a\uff0c\u660e\u786e\u4ea7\u54c1\u4e3a\u4e09\u7c7b\u533b\u7597\u5668\u68b0\uff0c\u8fd9\u662f\u6240\u6709\u540e\u7eed\u5de5\u4f5c\u7684\u57fa\u7840\u3002<\/p>\n<\/p>\n

2. \u5efa\u7acb\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb<\/strong><\/p>\n

\u4f01\u4e1a\u5fc5\u987b\u5728\u6ce8\u518c\u7533\u62a5\u524d\uff0c\u5efa\u7acb\u5e76\u8fd0\u884c\u7b26\u5408\u300a\u533b\u7597\u5668\u68b0\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff09\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u3002<\/p>\n<\/p>\n

\u8be5\u4f53\u7cfb\u9700\u6db5\u76d6\u8bbe\u8ba1\u5f00\u53d1\u3001\u751f\u4ea7\u3001\u8d28\u91cf\u63a7\u5236\u548c\u653e\u884c\u7b49\u5168\u8fc7\u7a0b\uff0c\u5e76\u6700\u7ec8\u901a\u8fc7\u836f\u76d1\u90e8\u95e8\u7684\u73b0\u573a\u6838\u67e5\u3002<\/p>\n<\/p>\n

3. \u4ea7\u54c1\u68c0\u9a8c\u4e0e\u578b\u5f0f\u68c0\u9a8c<\/strong><\/p>\n

\u5c06\u4ea7\u54c1\u9001\u4ea4\u5177\u6709\u8d44\u8d28\u7684\u533b\u7597\u5668\u68b0\u68c0\u9a8c\u673a\u6784\u8fdb\u884c\u578b\u5f0f\u68c0\u9a8c\u3002<\/p>\n<\/p>\n

\u68c0\u9a8c\u5185\u5bb9\u4e3b\u8981\u5305\u62ec\u4ea7\u54c1\u6027\u80fd\u6307\u6807\u3001\u5b89\u5168\u6307\u6807\uff08\u7535\u6c14\u5b89\u5168\u3001\u751f\u7269\u76f8\u5bb9\u6027\u3001\u7535\u78c1\u517c\u5bb9\u6027\u7b49\uff09\u3002<\/p>\n<\/p>\n

\u68c0\u9a8c\u5408\u683c\u540e\uff0c\u5c06\u53d6\u5f97\u68c0\u9a8c\u62a5\u544a\uff0c\u8fd9\u662f\u6ce8\u518c\u7533\u62a5\u7684\u5173\u952e\u652f\u6301\u6027\u6587\u4ef6\u4e4b\u4e00\u3002<\/p>\n<\/p>\n

4. \u4e34\u5e8a\u8bc4\u4ef7<\/strong><\/p>\n

\u8fd9\u662f\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u6ce8\u518c\u4e2d\u6700\u590d\u6742\u3001\u6700\u5173\u952e\u7684\u73af\u8282\u4e4b\u4e00\u3002<\/p>\n<\/p>\n

\u4f01\u4e1a\u9700\u901a\u8fc7\u4e34\u5e8a\u8bd5\u9a8c\u6216\u540c\u54c1\u79cd\u6bd4\u5bf9\u7684\u65b9\u5f0f\uff0c\u8bc1\u660e\u4ea7\u54c1\u7684\u5b89\u5168\u6709\u6548\u6027\u3002<\/p>\n<\/p>\n

\u82e5\u9700\u8981\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5219\u5fc5\u987b\u5411\u836f\u76d1\u5c40\u63d0\u4ea4\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\uff0c\u83b7\u6279\u540e\u5728\u5b9a\u70b9\u533b\u7597\u673a\u6784\u5f00\u5c55\u8bd5\u9a8c\uff0c\u5468\u671f\u957f\u3001\u6295\u5165\u5927\u3002<\/p>\n<\/p>\n

\u5b8c\u6210\u540e\u9700\u64b0\u5199\u8be6\u7ec6\u7684\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\u3002<\/p>\n<\/p>\n

5. \u6ce8\u518c\u7533\u62a5\u8d44\u6599\u51c6\u5907\u4e0e\u63d0\u4ea4<\/strong><\/p>\n

\u6c47\u96c6\u6240\u6709\u6280\u672f\u8d44\u6599\uff0c\u64b0\u5199\u5e76\u51c6\u5907\u6ce8\u518c\u7533\u62a5\u8d44\u6599\u3002<\/p>\n<\/p>\n

\u8fd9\u5957\u8d44\u6599\u4f53\u7cfb\u5e9e\u5927\uff0c\u901a\u5e38\u5305\u62ec\uff1a\u6ce8\u518c\u7533\u8bf7\u8868\u3001\u7814\u7a76\u8d44\u6599\uff08\u6027\u80fd\u7814\u7a76\u3001\u751f\u7269\u76f8\u5bb9\u6027\u3001\u7a33\u5b9a\u6027\u7b49\uff09\u3001\u751f\u4ea7\u5236\u9020\u4fe1\u606f\u3001\u4e34\u5e8a\u8bc4\u4ef7\u8d44\u6599\u3001\u4ea7\u54c1\u98ce\u9669\u5206\u6790\u3001\u4ea7\u54c1\u6280\u672f\u8981\u6c42\u3001\u4ea7\u54c1\u8bf4\u660e\u4e66\u548c\u6807\u7b7e\u6837\u7a3f\u7b49\u3002<\/p>\n<\/p>\n

\u51c6\u5907\u5b8c\u6bd5\u540e\uff0c\u901a\u8fc7\u56fd\u5bb6\u836f\u76d1\u5c40\u7f51\u4e0a\u529e\u4e8b\u5927\u5385\u63d0\u4ea4\u7535\u5b50\u7533\u62a5\u8d44\u6599\u3002<\/p>\n<\/p>\n

6. \u6280\u672f\u5ba1\u8bc4\u4e0e\u53d1\u8865<\/strong><\/p>\n

NMPA\u533b\u7597\u5668\u68b0\u6280\u672f\u5ba1\u8bc4\u4e2d\u5fc3\uff08CMDE\uff09\u5c06\u5bf9\u7533\u62a5\u8d44\u6599\u8fdb\u884c\u8be6\u5c3d\u7684\u6280\u672f\u5ba1\u8bc4\u3002<\/p>\n<\/p>\n

\u5728\u6b64\u8fc7\u7a0b\u4e2d\uff0c\u5ba1\u8bc4\u8001\u5e08\u5f88\u53ef\u80fd\u53d1\u51fa\u8865\u5145\u8d44\u6599\u901a\u77e5\uff08\u53d1\u8865\uff09\uff0c\u8981\u6c42\u4f01\u4e1a\u5bf9\u8d44\u6599\u4e2d\u7684\u7591\u95ee\u6216\u7f3a\u5931\u8fdb\u884c\u89e3\u91ca\u8bf4\u660e\u548c\u8865\u5145\u3002<\/p>\n<\/p>\n

\u4f01\u4e1a\u9700\u5728\u89c4\u5b9a\u65f6\u9650\u5185\u5b8c\u6210\u53d1\u8865\u56de\u590d\u3002<\/p>\n<\/p>\n

7. \u4f53\u7cfb\u6838\u67e5\u4e0e\u884c\u653f\u5ba1\u6279<\/strong><\/p>\n

\u5728\u6280\u672f\u5ba1\u8bc4\u8fc7\u7a0b\u4e2d\u6216\u4e4b\u540e\uff0c\u836f\u76d1\u90e8\u95e8\u4f1a\u7ec4\u7ec7\u4e13\u5bb6\u5bf9\u751f\u4ea7\u573a\u5730\u8fdb\u884c\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u73b0\u573a\u6838\u67e5\uff0c\u4ee5\u9a8c\u8bc1\u751f\u4ea7\u6761\u4ef6\u7684\u5408\u89c4\u6027\u4e0e\u4e00\u81f4\u6027\u3002<\/p>\n<\/p>\n

\u901a\u8fc7\u6280\u672f\u5ba1\u8bc4\u548c\u4f53\u7cfb\u6838\u67e5\u540e\uff0c\u5c06\u8fdb\u5165\u884c\u653f\u5ba1\u6279\u73af\u8282\u3002<\/p>\n<\/p>\n

\u6700\u7ec8\uff0c\u7b26\u5408\u89c4\u5b9a\u7684\u4ea7\u54c1\u5c06\u88ab\u51c6\u4e88\u6ce8\u518c\uff0c\u9881\u53d1\u300a\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8bc1\u300b\u3002<\/p>\n<\/p>\n

\u4e09\u3001 \u529e\u7406\u8fc7\u7a0b\u4e2d\u7684\u5e38\u89c1\u96be\u70b9\u4e0e\u5e94\u5bf9\u7b56\u7565<\/strong><\/p>\n

\u4f01\u4e1a\u5728\u529e\u7406\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u6ce8\u518c\u65f6\uff0c\u5e38\u4f1a\u9047\u5230\u4ee5\u4e0b\u6311\u6218\uff1a<\/p>\n<\/p>\n

\u96be\u70b9\u4e00\uff1a\u4e34\u5e8a\u8bc4\u4ef7\u8def\u5f84\u9009\u62e9\u4e0e\u5b9e\u65bd<\/strong><\/p>\n

\u4e34\u5e8a\u8bd5\u9a8c\u8017\u8d44\u5de8\u5927\u3001\u5468\u671f\u6f2b\u957f\uff0c\u4e14\u65b9\u6848\u8bbe\u8ba1\u79d1\u5b66\u6027\u8981\u6c42\u6781\u9ad8\u3002<\/p>\n<\/p>\n

\u7b56\u7565\uff1a\u5c3d\u65e9\u4e0e\u4e34\u5e8a\u4e13\u5bb6\u548c\u7edf\u8ba1\u4e13\u5bb6\u5408\u4f5c\uff0c\u8bbe\u8ba1\u4e25\u8c28\u7684\u8bd5\u9a8c\u65b9\u6848\uff1b\u82e5\u80fd\u901a\u8fc7\u540c\u54c1\u79cd\u6bd4\u5bf9\u8def\u5f84\u5b8c\u6210\u4e34\u5e8a\u8bc4\u4ef7\uff0c\u5c06\u5927\u5e45\u8282\u7701\u65f6\u95f4\u548c\u6210\u672c\uff0c\u4f46\u9700\u786e\u4fdd\u5bf9\u6bd4\u6570\u636e\u7684\u53ef\u53ca\u6027\u4e0e\u5145\u5206\u6027\u3002<\/p>\n<\/p>\n

\u96be\u70b9\u4e8c\uff1a\u6ce8\u518c\u8d44\u6599\u7f16\u5199\u8d28\u91cf<\/strong><\/p>\n

\u6ce8\u518c\u8d44\u6599\u662f\u5ba1\u8bc4\u7684\u6838\u5fc3\u4f9d\u636e\uff0c\u5176\u79d1\u5b66\u6027\u3001\u903b\u8f91\u6027\u548c\u89c4\u8303\u6027\u81f3\u5173\u91cd\u8981\u3002<\/p>\n<\/p>\n

\u7b56\u7565\uff1a\u7ec4\u5efa\u4e13\u4e1a\u7684\u6ce8\u518c\u7533\u62a5\u56e2\u961f\uff08RA\uff09\uff0c\u6216\u59d4\u6258\u7ecf\u9a8c\u4e30\u5bcc\u7684CRO\uff08\u5408\u540c\u7814\u7a76\u7ec4\u7ec7\uff09\u534f\u52a9\uff0c\u786e\u4fdd\u8d44\u6599\u5185\u5bb9\u8be6\u5b9e\u3001\u683c\u5f0f\u89c4\u8303\u3001\u8bba\u8bc1\u5145\u5206\u3002<\/p>\n<\/p>\n

\u96be\u70b9\u4e09\uff1a\u4e0e\u5ba1\u8bc4\u90e8\u95e8\u7684\u6c9f\u901a<\/strong><\/p>\n

\u5e94\u5bf9\u53d1\u8865\u548c\u6c9f\u901a\u4ea4\u6d41\u4f1a\u9700\u8981\u4e13\u4e1a\u7684\u6c9f\u901a\u6280\u5de7\u548c\u6df1\u539a\u7684\u4e13\u4e1a\u77e5\u8bc6\u3002<\/p>\n<\/p>\n

\u7b56\u7565\uff1a\u63d0\u524d\u5145\u5206\u51c6\u5907\uff0c\u9488\u5bf9\u5ba1\u8bc4\u4e2d\u5fc3\u63d0\u51fa\u7684\u95ee\u9898\uff0c\u63d0\u4f9b\u6e05\u6670\u3001\u51c6\u786e\u3001\u57fa\u4e8e\u79d1\u5b66\u8bc1\u636e\u7684\u7b54\u590d\uff0c\u5fc5\u8981\u65f6\u7533\u8bf7\u9762\u5bf9\u9762\u6c9f\u901a\u3002<\/p>\n<\/p>\n

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\u53d6\u5f97\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8bc1\u5e76\u4e0d\u610f\u5473\u7740\u76d1\u7ba1\u7684\u7ed3\u675f\uff0c\u800c\u662f\u65b0\u4e00\u8f6e\u7ba1\u7406\u7684\u5f00\u59cb\u3002<\/p>\n<\/p>\n

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