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      2022\u5e7412\u6708\uff0c\u7f8e\u56fd\u56fd\u4f1a\u901a\u8fc7\u4e86\u201c\u5316\u5986\u54c1\u6cd5\u89c4\u73b0\u4ee3\u5316\u6cd5\u6848\u201d\uff08\u201cMoCRA\u201d\uff09\uff0c\u8be5\u6cd5\u6848\u5927\u5e45\u63d0\u9ad8\u4e86\u5bf9\u5316\u5986\u54c1\u7684\u8981\u6c42\u3002\u5b83\u5305\u62ec\u9999\u6c34\u8fc7\u654f\u539f\u7684\u65b0\u6807\u7b7e\u8981\u6c42\u548c\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a\u8054\u7cfb\u4eba\u3002\u5b83\u73b0\u5728\u8fd8\u8981\u6c42\u67d0\u4e9b\u4f01\u4e1a\u5411FDA\u6ce8\u518c\u548c\/\u6216\u5217\u51fa\u5176\u4ea7\u54c1\u3002[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”\u6211\u8ba4\u4e3a\u6211\u7684\u4ea7\u54c1\u53ef\u80fd\u4f5c\u4e3a\u975e\u5904\u65b9\u836f\u53d7\u5230\u76d1\u7ba1\uff1b\u6211\u5982\u4f55\u624d\u80fd\u77e5\u9053\uff1f\u53c8\u8be5\u5982\u4f55\u6807\u6ce8\uff1f” tab_id=”faq7″ el_class=”prior-faq-sec”][vc_column_text]\u6839\u636eFDA\u7684\u5b9a\u4e49\uff0c\u836f\u54c1\u662f\u6307\u201c\u7528\u4e8e\u8bca\u65ad\u3001\u6cbb\u6108\u3001\u7f13\u89e3\u3001\u6cbb\u7597\u6216\u9884\u9632\u75be\u75c5\u201d\u548c\u201c(\u98df\u7269\u9664\u5916)\u5f71\u54cd\u8eab\u4f53\u7ed3\u6784\u6216\u4efb\u4f55\u529f\u80fd\u7684\u4efb\u4f55\u4ea7\u54c1\u3002\u201d \u4efb\u4f55\u7b26\u5408\u8be5\u5b9a\u4e49\u7684\u4ea7\u54c1\u90fd\u53ef\u4ee5\u4f5c\u4e3a\u836f\u54c1\u7531FDA\u76d1\u7ba1\u3002\u56e0\u6b64\uff0c\u8bb8\u591a\u901a\u5e38\u4f5c\u4e3a\u5316\u5986\u54c1\u9500\u552e\u7684\u4ea7\u54c1\u53ef\u80fd\u4f1a\u88ab\u4f5c\u4e3a\u836f\u54c1\u53d7\u5230FDA\u7684\u76d1\u7ba1\uff0c\u4f8b\u5982\u9632\u6652\u971c\uff0c\u75e4\u75ae\u6cbb\u7597\u4ea7\u54c1\uff0c\u542b\u6c1f\u7259\u818f\u548c\u5e72\u88c2\u62a4\u80a4\u971c\u3002<\/p>\n

      \u836f\u54c1\u5fc5\u987b\u7b26\u5408\u6700\u7ec8\u7248\u836f\u5178\u4e13\u9898\u7684\u8981\u6c42\uff0c\u6216\u901a\u8fc7\u65b0\u836f\u7533\u8bf7(\u201cNDA\u201d)\u6d41\u7a0b\u83b7\u5f97FDA\u6279\u51c6\u3002\u4e13\u9898\u89c4\u5b9a\u4e86\u7279\u5b9a\u836f\u7269\u7c7b\u522b\u5141\u8bb8\u4f7f\u7528\u7684\u6d3b\u6027\u6210\u5206\uff0c\u5e76\u8981\u6c42\u5728\u6807\u7b7e\u4e2d\u5305\u542b\u5177\u4f53\u8bf4\u660e\u3002\u4e00\u822c\u6765\u8bf4\uff0c\u836f\u54c1\u6807\u7b7e\u8981\u6c42\u6ce8\u660e\u836f\u54c1\u540d\u79f0\u3001\u51c0\u542b\u91cf\u3001\u201c\u836f\u7269\u6210\u5206\u201d\u3001\u7528\u4e8e\u62a5\u544a\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u7684\u7f8e\u56fd\u7535\u8bdd\u53f7\u7801\u6216\u90ae\u5bc4\u5730\u5740\uff0c\u4ee5\u53ca\u751f\u4ea7\u5546\u3001\u5305\u88c5\u5546\u6216\u5206\u9500\u5546\u7684\u540d\u79f0\u3002\u6807\u7b7e\u8981\u6c42\u53ef\u5728\u8054\u90a6\u6cd5\u89c4\u7b2c21\u7bc7\u3001FDA\u53d1\u5e03\u7684\u6307\u5bfc\u6587\u4ef6\u4ee5\u53ca\u7279\u5b9a\u836f\u7269\u7c7b\u522b\u7684\u4e13\u9898\u4e2d\u627e\u5230\u3002<\/p>\n

      \u836f\u54c1\u5728\u7f8e\u56fd\u4e0a\u5e02\u4e4b\u524d\uff0c\u987b\u9075\u5faa\u6ce8\u518c\u548c\u4ea7\u54c1\u5217\u540d\u8981\u6c42\u3002[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”\u6211\u751f\u4ea7\u5ba0\u7269\u98df\u54c1\u3002FDA\u5bf9\u6b64\u7c7b\u4ea7\u54c1\u662f\u5426\u6709\u7279\u5b9a\u7684\u6807\u7b7e\u8981\u6c42\uff1f” tab_id=”faq8″ el_class=”prior-faq-sec”][vc_column_text]FDA\u6709\u6743\u76d1\u7ba1\u52a8\u7269\u9972\u6599\uff0c\u5305\u62ec\u5ba0\u7269\u98df\u54c1\u548c\u8865\u5145\u5242\u4ea7\u54c1\u3002\u8be5\u673a\u6784\u4e0e\u7f8e\u56fd\u9972\u6599\u63a7\u5236\u5b98\u5458\u534f\u4f1a\uff08\u201cAAFCO\u201d\uff09\u5408\u4f5c\uff0c\u540e\u8005\u662f\u7f8e\u56fd\u5404\u5dde\u548c\u8054\u90a6\u653f\u5e9c\u673a\u6784\u81ea\u613f\u7ec4\u6210\u7684\u4f1a\u5458\u7ec4\u7ec7\uff0c\u8d1f\u8d23\u7ba1\u7406\u52a8\u7269\u9972\u6599\u7684\u751f\u4ea7\uff0c\u6807\u7b7e\uff0c\u7ecf\u9500\uff0c\u4f7f\u7528\u548c\u9500\u552e\u3002<\/p>\n

      FDA\u6807\u7b7e\u8981\u6c42\u5305\u62ec\u540d\u79f0\u3001\u51c0\u542b\u91cf\u3001\u6210\u5206\u8868\u4ee5\u53ca\u751f\u4ea7\u5546\u3001\u5305\u88c5\u5546\u6216\u5206\u9500\u5546\u7684\u540d\u79f0\u3002\u5ba0\u7269\u98df\u54c1\u6807\u7b7e\u901a\u5e38\u7531AAFCO\u5728\u5b98\u65b9\u51fa\u7248\u7269 \uff08\u201cOP\u201d\uff09 \u4e2d\u89c4\u5b9a\u7684\u8981\u6c42\u8fdb\u884c\u8865\u5145\u3002\u8fd9\u4e9b\u8981\u6c42\u5305\u62ec\u5404\u4e2a\u5dde\u7684\u8981\u6c42\uff0c\u4f8b\u5982\u201c\u4fdd\u8bc1\u5206\u6790\u201d\u3001\u76ee\u7684\u58f0\u660e\uff0c\u4ee5\u53ca\u53ef\u4ee5\u53c2\u8003\u7684\u4ea7\u54c1\u6216\u5176\u6210\u5206\u7684\u58f0\u660e\u7c7b\u578b\u7684\u989d\u5916\u9650\u5236\u3002[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”\u6211\u7684\u533b\u7597\u5668\u68b0\u6807\u7b7e\u4e0a\u5fc5\u987b\u8868\u660e\u54ea\u4e9b\u5185\u5bb9\uff1f” tab_id=”faq9″ el_class=”prior-faq-sec”][vc_column_text]\u533b\u7597\u5668\u68b0\u6807\u7b7e\u6cd5\u89c4\u5c06\u8981\u6c42\u975e\u5904\u65b9\uff08\u201cOTC\u201d\uff09\u4ea7\u54c1\u7684\u7279\u6027\u548c\u51c0\u542b\u91cf\u8fdb\u884c\u8bf4\u660e\u3002\u6240\u6709\u533b\u7597\u5668\u68b0\uff08\u5305\u62ec\u5904\u65b9\u5668\u68b0\uff09\u5e94\u58f0\u660e\u9884\u671f\u7528\u9014\u3001\u8be6\u7ec6\u7684\u4f7f\u7528\u8bf4\u660e\u3001\u7981\u5fcc\u75c7\u548c\u8b66\u544a\u4ee5\u53ca\u552f\u4e00\u7684\u5668\u68b0\u6807\u8bc6\u7b26\uff08\u201cUDI\u201d\uff09\u3002\u5904\u65b9\u533b\u7597\u5668\u68b0\u8fd8\u5fc5\u987b\u6709\u989d\u5916\u7684\u58f0\u660e\u6216\u7b26\u53f7\u6765\u6807\u8bc6\u81ea\u5df1\u3002<\/p>\n

      \u533b\u7597\u5668\u68b0\u6807\u7b7e\u6cd5\u89c4\u9002\u7528\u4e8e\u624b\u672f\u5200\u7b49\u7b80\u5355\u4ea7\u54c1\u548c\u8d85\u58f0\u673a\u5668\u7b49\u590d\u6742\u4ea7\u54c1\uff0c\u8fd9\u610f\u5473\u7740\u5b83\u4eec\u53ef\u80fd\u5dee\u5f02\u5f88\u5927\u3002\u9664\u4e00\u822c\u6807\u7b7e\u6cd5\u89c4\u5916\uff0c\u516c\u53f8\u8fd8\u5e94\u7814\u7a76FDA\u53ef\u80fd\u9488\u5bf9\u5176\u7279\u5b9a\u5668\u68b0\u5236\u5b9a\u7684\u4efb\u4f55\u5177\u4f53\u6307\u5bfc\u6587\u4ef6\uff0c\u4ee5\u786e\u4fdd\u5305\u542b\u6240\u6709\u5f3a\u5236\u6027\u6216\u5efa\u8bae\u6027\u7684\u58f0\u660e\u3002[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”\u6211\u5982\u4f55\u77e5\u9053\u6211\u7684\u539f\u6599\u662f\u5426\u9002\u5408\u7f8e\u56fd\u5e02\u573a\uff1f” tab_id=”faq10″ el_class=”prior-faq-sec”][vc_column_text]\u4e0d\u540c\u5e02\u573a\u7684\u6210\u5206\u89c4\u5b9a\u53ef\u80fd\u5b58\u5728\u5f88\u5927\u5dee\u5f02\u3002\u5728\u7f8e\u56fd\u4ee5\u5916\u88ab\u8ba4\u4e3a\u53ef\u63a5\u53d7\u7684\u6210\u5206\u53ef\u80fd\u4e0eFDA\u7684\u8981\u6c42\u4e0d\u540c\u3002\u5176\u4e2d\u4e00\u4e2a\u91cd\u8981\u4f8b\u5b50\u662f\u8272\u7d20\u6dfb\u52a0\u5242\u3002\u8272\u7d20\u6dfb\u52a0\u5242\u8fdd\u89c4\u5f88\u5e38\u89c1\uff0c\u56e0\u4e3aFDA\u8981\u6c42\u6bcf\u79cd\u8272\u7d20\u6dfb\u52a0\u5242\uff08\u751a\u81f3\u662f\u5929\u7136\u6765\u6e90\u7684\u6dfb\u52a0\u5242\uff09\u90fd\u7ecf\u8fc7\u6279\u51c6\u3002<\/p>\n

      \u5e38\u89c4\u98df\u54c1\u914d\u6599\u5fc5\u987b\u88ab\u6279\u51c6\u4f5c\u4e3a\u98df\u54c1\u6dfb\u52a0\u5242\uff0c\u6216\u88ab\u516c\u8ba4\u4e3a\u5bf9\u5176\u9884\u671f\u7528\u9014\u662f\u5b89\u5168\u7684\uff08\u201cGRAS\u201d\uff09\u3002\u8865\u5145\u5242\u4e2d\u542b\u6709\u7684\u81b3\u98df\u6210\u5206\u4e0d\u53d7\u6b64\u8981\u6c42\u7684\u9650\u5236\uff0c\u4f46\u5982\u679c\u57281994\u5e7410\u670815\u65e5\u4e4b\u524d\u5728\u7f8e\u56fd\u6ca1\u6709\u4ee5\u8865\u5145\u5242\u5f62\u5f0f\u9500\u552e\uff0c\u5219\u987b\u9075\u5b88\u201c\u65b0\u81b3\u98df\u6210\u5206\u901a\u77e5\u201d\u7684\u8981\u6c42\u3002<\/p>\n

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