{"id":1799,"date":"2024-12-17T15:53:42","date_gmt":"2024-12-17T07:53:42","guid":{"rendered":"https:\/\/www.vcro.com.tw\/cn\/?p=1799"},"modified":"2024-12-17T15:53:45","modified_gmt":"2024-12-17T07:53:45","slug":"%e4%b8%8efda%e7%9a%84%e6%ad%a3%e5%bc%8f%e4%bc%9a%e8%ae%ae%e8%a7%a3%e8%af%bb","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/cn\/?p=1799","title":{"rendered":"\u4e0eFDA\u7684\u6b63\u5f0f\u4f1a\u8bae\u89e3\u8bfb"},"content":{"rendered":"\n

FDA\u4e0e\u7533\u529e\u65b9\u4e4b\u95f4\u7684\u4f1a\u8bae\u5212\u5206\u4e3a\u516d\u79cd\u4e0d\u540c\u7c7b\u578b\uff0c\u4ee5\u534f\u52a9\u63a8\u52a8\u4ea7\u54c1\u5f00\u53d1\u5e76\u63d0\u4f9b\u76d1\u7ba1\u5efa\u8bae\u3002
\u8fd9\u4e9b\u4f1a\u8bae\u6db5\u76d6\u4e86\u4e0d\u540c\u7684\u4ea7\u54c1\u5f00\u53d1\u9636\u6bb5\u53ca\u9700\u6c42\uff0c\u5e76\u6709\u4e0d\u540c\u7684\u7533\u8bf7\u6761\u4ef6\u548c\u65f6\u9650\u3002<\/p>\n\n\n\n

\u4f1a\u8bae\u7c7b\u578b<\/summary>\n
    \n
  1. A\u7c7b\u4f1a\u8bae
    A\u7c7b\u4f1a\u8bae\u9002\u7528\u4e8e\u4ea7\u54c1\u5f00\u53d1\u53d7\u963b\u6216\u6709\u91cd\u5927\u5b89\u5168\u95ee\u9898\u9700\u8981\u89e3\u51b3\u7684\u60c5\u51b5\u3002\u4f8b\u5982\uff0c\u4e89\u8bae\u89e3\u51b3\u4f1a\u8bae\u3001\u8ba8\u8bba\u4e34\u5e8a\u6682\u505c\u7684\u4f1a\u8bae\u3001FDA\u4e0d\u8ba4\u53ef\u7684\u7279\u6b8a\u65b9\u6848\u8bc4\u4f30\u7ed3\u679c\u7684\u4f1a\u8bae\uff0c\u6216\u662f\u5728\u6536\u5230\u4e0d\u6279\u51c6\u4fe1\u540e\u7684\u4e09\u4e2a\u6708\u5185\u7533\u8bf7\u7684\u4f1a\u8bae\u3002A\u7c7b\u4f1a\u8bae\u7684\u7533\u8bf7\u9700\u9644\u4e0a\u4f1a\u8bae\u6570\u636e\u62a5\uff0c\u4ee5\u4fbf\u4e8eFDA\u8bc4\u4f30\u4f1a\u8bae\u7684\u5fc5\u8981\u6027\u3002<\/li>\n\n\n\n
  2. B\u7c7b\u4f1a\u8bae
    B\u7c7b\u4f1a\u8bae\u6db5\u76d6\u4ea7\u54c1\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u7684\u91cd\u8981\u91cc\u7a0b\u7891\u4f1a\u8bae\uff0c\u5305\u62ec\uff1a
    – \u524d\u671f\u65b0\u836f\uff08pre-IND\uff09\u4f1a\u8bae
    – \u7d27\u6025\u6388\u6743\u524d\u4f1a\u8bae
    – \u65b0\u836f\u6216\u751f\u7269\u5236\u54c1\u8bb8\u53ef\u8bc1\uff08pre-NDA\/BLA\uff09\u4f1a\u8bae
    – \u9488\u5bf9\u7a81\u7834\u6027\u7597\u6cd5\u6216\u518d\u751f\u533b\u5b66\u5148\u8fdb\u7597\u6cd5\u4ea7\u54c1\u7684\u53d1\u5c55\u8ba1\u5212\u4f1a\u8bae<\/li>\n\n\n\n
  3. B\uff08EOP\uff09\u7c7b\u4f1a\u8bae
    B\uff08EOP\uff09\u7c7b\u4f1a\u8bae\u662f\u6307\u7279\u5b9a\u7684\u9636\u6bb5\u7ed3\u675f\u4f1a\u8bae\uff0c\u5982\u7b2c\u4e00\u9636\u6bb5\u7ed3\u675f\u4f1a\u8bae\uff08EOP1\uff09\u548c\u7b2c\u4e8c\u9636\u6bb5\u7ed3\u675f\u6216\u7b2c\u4e09\u9636\u6bb5\u524d\u4f1a\u8bae\uff08EOP2\uff09\uff0c\u901a\u5e38\u9488\u5bf9\u6709\u6761\u4ef6\u52a0\u901f\u6279\u51c6\u7684\u4ea7\u54c1\u6216\u5177\u6709\u7279\u6b8a\u7528\u9014\u7684\u4ea7\u54c1\u8fdb\u884c\u5ba1\u67e5\u3002<\/li>\n\n\n\n
  4. C\u7c7b\u4f1a\u8bae
    C\u7c7b\u4f1a\u8bae\u9002\u7528\u4e8e\u9664\u4e0a\u8ff0\u4ee5\u5916\u7684\u4ea7\u54c1\u5f00\u53d1\u53ca\u5ba1\u67e5\u95ee\u9898\uff0c\u4f8b\u5982\u5c31\u65b0\u66ff\u4ee3\u7ec8\u70b9\u6807\u8bb0\u7684\u65e9\u671f\u54a8\u8be2\u6216FDA\u5728\u7279\u5b9a\u4f7f\u7528\u60c5\u5883\u4e2d\u5bf9\u5176\u8fdb\u884c\u9996\u6b21\u6279\u51c6\u7684\u610f\u89c1\u3002<\/li>\n\n\n\n
  5. D\u7c7b\u4f1a\u8bae
    D\u7c7b\u4f1a\u8bae\u4e13\u6ce8\u4e8e\u5c11\u6570\u7279\u5b9a\u8bae\u9898\uff0c\u901a\u5e38\u6d89\u53ca\u4e00\u5230\u4e24\u4e2a\u95ee\u9898\uff0c\u63d0\u4f9b\u5173\u952e\u6027\u610f\u89c1\u4ee5\u652f\u6301\u4ea7\u54c1\u5f00\u53d1\u3002\u4f8b\u5982\uff0c\u5728\u4e4b\u524d\u7684\u6b63\u5f0f\u4f1a\u8bae\u540e\u7684\u7279\u5b9a\u8ddf\u8fdb\u95ee\u9898\u3001\u5173\u4e8e\u521b\u65b0\u5f00\u53d1\u65b9\u6cd5\u7684\u7b80\u5355\u95ee\u9898\u7b49\u3002<\/li>\n\n\n\n
  6. INTERACT\u4f1a\u8bae
    INTERACT\u4f1a\u8bae\u65e8\u5728\u652f\u6301\u65b0\u9896\u7684\u4ea7\u54c1\u548c\u53d1\u5c55\u8ba1\u5212\uff0c\u89e3\u51b3\u65e9\u671f\u5f00\u53d1\u4e2d\u9762\u4e34\u7684\u72ec\u7279\u6311\u6218\uff0c\u901a\u5e38\u5728\u63d0\u4ea4IND\u4e4b\u524d\u8fdb\u884c\u3002\u8fd9\u7c7b\u4f1a\u8bae\u591a\u6d89\u53ca\u6bd2\u7406\u5b66\u7814\u7a76\u3001\u590d\u6742\u5236\u9020\u6280\u672f\u3001\u521b\u65b0\u8bbe\u5907\u7684\u4f7f\u7528\u7b49\u95ee\u9898\u3002<\/li>\n<\/ol>\n<\/details>\n\n\n\n
    \u4f1a\u8bae\u5f62\u5f0f<\/summary>\n

    \u4f1a\u8bae\u53ef\u4ee5\u91c7\u53d6\u4ee5\u4e0b\u56db\u79cd\u5f62\u5f0f\uff1a
    –\u00a0 \u9762\u5bf9\u9762\u4f1a\u8bae\uff1a\u53c2\u4f1a\u4eba\u5458\u4eb2\u81ea\u5230FDA\u53c2\u52a0\uff0c\u5e76\u53ef\u8bbe\u6709\u865a\u62df\u53c2\u52a0\u8005
    –\u00a0 \u865a\u62df\u9762\u5bf9\u9762\u4f1a\u8bae\uff1a\u6240\u6709\u53c2\u4e0e\u8005\u901a\u8fc7\u89c6\u9891\u4f1a\u8bae\u5e73\u53f0\u8fdc\u7a0b\u53c2\u52a0
    –\u00a0 \u7535\u8bdd\u4f1a\u8bae\uff1a\u4ec5\u901a\u8fc7\u8bed\u97f3\u8054\u673a\u7684\u65b9\u5f0f\u8fdb\u884c\u4f1a\u8bae
    – \u4e66\u9762\u56de\u590d\uff08WRO\uff09\uff1a\u82e5\u4f1a\u8bae\u9700\u6c42\u53ef\u4ee5\u4ee5\u4e66\u9762\u56de\u590d\u89e3\u51b3\uff0cFDA\u5c06\u9009\u62e9\u4e66\u9762\u5f62\u5f0f\u4f5c\u4e3a\u66ff\u4ee3<\/p>\n<\/details>\n\n\n\n

    \u65f6\u7a0b\u5b89\u6392<\/summary>\n

    \u4e0d\u540c\u7c7b\u578b\u4f1a\u8bae\u7684\u54cd\u5e94\u548c\u53ec\u5f00\u65f6\u9650\u5982\u4e0b\uff1a
    – A\u7c7b\u4f1a\u8bae\uff1a\u81ea\u6536\u5230\u7533\u8bf7\u4e4b\u65e5\u8d7730\u5929\u5185\u53ec\u5f00
    –\u00a0 B\u7c7b\u4f1a\u8bae\uff1a60\u5929\u5185\u53ec\u5f00
    –\u00a0 B\uff08EOP\uff09\u7c7b\u4f1a\u8bae\uff1a70\u5929\u5185\u53ec\u5f00
    –\u00a0 C\u7c7b\u4f1a\u8bae\uff1a75\u5929\u5185\u53ec\u5f00
    –\u00a0 D\u7c7b\u4f1a\u8bae\uff1a50\u5929\u5185\u53ec\u5f00
    –\u00a0 INTERACT\u4f1a\u8bae\uff1a75\u5929\u5185\u53ec\u5f00
    – \u4e66\u9762\u56de\u590d\u5219\u4e0e\u4e0a\u8ff0\u4f1a\u8bae\u5b89\u6392\u7684\u65f6\u9650\u76f8\u540c<\/p>\n<\/details>\n\n\n\n

    \u4f1a\u8bae\u5f62\u5f0f\u7684\u6700\u7ec8\u51b3\u5b9a\u6743\u5728FDA\u624b\u4e2d\u3002\u867d\u7136\u7533\u529e\u65b9\u53ef\u4ee5\u63d0\u51fa\u5e0c\u671b\u7684\u4f1a\u8bae\u5f62\u5f0f\uff08\u4f8b\u5982\u9762\u5bf9\u9762\u3001\u7535\u8bdd\u4f1a\u8bae\u6216\u4e66\u9762\u56de\u590d\uff09\uff0c\u4f46FDA\u5c06\u6839\u636e\u4f1a\u8bae\u9700\u6c42\u7684\u5177\u4f53\u60c5\u51b5\u6765\u51b3\u5b9a\u662f\u5426\u6279\u51c6\u8be5\u5f62\u5f0f\u3002<\/p>\n\n\n\n

    \u5bf9\u4e8e\u67d0\u4e9b\u4f1a\u8bae\uff08\u5982pre-IND\u3001C\u7c7b\u3001D\u7c7b\u548cINTERACT\u4f1a\u8bae\uff09\uff0c\u5373\u4f7f\u7533\u529e\u65b9\u8981\u6c42\u9762\u5bf9\u9762\u6216\u865a\u62df\u4f1a\u8bae\uff0cFDA\u4e5f\u53ef\u80fd\u51b3\u5b9a\u4ee5\u4e66\u9762\u56de\u590d\uff08WRO\uff09\u65b9\u5f0f\u63d0\u4f9b\u53cd\u9988\u3002\u5982\u679cFDA\u8ba4\u4e3a\u4e66\u9762\u56de\u590d\u80fd\u66f4\u6709\u6548\u5730\u6ee1\u8db3\u4f1a\u8bae\u9700\u6c42\uff0c\u5219\u4f1a\u901a\u77e5\u7533\u529e\u65b9\u9884\u8ba1\u53d1\u9001\u56de\u590d\u7684\u65f6\u95f4\u3002\u5982\u679c\u7533\u529e\u65b9\u4ecd\u7136\u8ba4\u4e3a\u6709\u5fc5\u8981\u8fdb\u884c\u4f1a\u8bae\uff0c\u53ef\u4ee5\u63d0\u4f9b\u8fdb\u4e00\u6b65\u7406\u7531\uff0cFDA\u4f1a\u6839\u636e\u8fd9\u4e9b\u7406\u7531\u91cd\u65b0\u8003\u8651\u662f\u5426\u6539\u4e3a\u53ec\u5f00\u4f1a\u8bae\u3002<\/p>\n\n\n\n

    \u4f1a\u8bae\u7684\u7c7b\u578b\uff0c\u4f8b\u5982Type D\uff0cInteract\u4f1a\u8bae\u7684\u9009\u62e9\uff0c\u662f\u7531\u7533\u529e\u65b9\u8fd8\u662fFDA\u51b3\u5b9a\u5462?<\/summary>\n

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    \u7136\u800c\uff0cFDA\u5728\u8bc4\u4f30\u540e\u53ef\u80fd\u8ba4\u4e3a\u53e6\u4e00\u7c7b\u578b\u7684\u4f1a\u8bae\u66f4\u4e3a\u9002\u5408\uff0c\u5c24\u5176\u5f53\u8bae\u9898\u8f83\u590d\u6742\u6216\u6d89\u53ca\u591a\u4e2a\u5b66\u79d1\u65f6\uff0cFDA\u4f1a\u901a\u77e5\u7533\u529e\u65b9\u8f6c\u6362\u4e3a\u66f4\u5408\u9002\u7684\u4f1a\u8bae\u7c7b\u578b\uff08\u5982\u5c06Type D\u6539\u4e3aType C\u6216Type B\u4f1a\u8bae\uff09\u3002<\/p>\n\n\n\n

    \u4f8b\u5982\uff0cType D\u4f1a\u8bae\u4e00\u822c\u9002\u7528\u4e8e\u8303\u56f4\u8f83\u7a84\u7684\u95ee\u9898\uff0c\u82e5\u7533\u529e\u65b9\u63d0\u51fa\u7684\u95ee\u9898\u8fc7\u591a\u6216\u8fc7\u4e8e\u590d\u6742\uff0cFDA\u53ef\u80fd\u4f1a\u5efa\u8bae\u8f6c\u4e3aType C\u4f1a\u8bae\u3002\u6b64\u5916\uff0cINTERACT\u4f1a\u8bae\u901a\u5e38\u7528\u4e8e\u4ea7\u54c1\u65e9\u671f\u5f00\u53d1\u9636\u6bb5\uff08\u4f8b\u5982IND\u63d0\u4ea4\u524d\uff09\uff0c\u5982FDA\u8ba4\u4e3a\u5176\u4ed6\u7c7b\u578b\u7684\u4f1a\u8bae\uff08\u4f8b\u5982Type B\u4f1a\u8bae\uff09\u66f4\u9002\u5408\u65f6\uff0c\u4e5f\u4f1a\u8fdb\u884c\u8f6c\u6362\u3002<\/p>\n<\/details>\n\n\n\n

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    \"VCRO<\/figure>\n\n\n\n

    Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry
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