{"id":74984,"date":"2019-01-17T00:00:50","date_gmt":"2019-02-01T05:39:24","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/74984\/"},"modified":"2019-02-01T13:39:25","modified_gmt":"2019-02-01T05:39:25","slug":"7f06897df6","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/74984\/","title":{"rendered":"\u5e72\u8d27 | \u4e00\u6587\u8bb2\u900f\u7f8e\u56fdDMF"},"content":{"rendered":"
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\u524d\u8a00<\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/section>\n


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\u7b14\u8005\u5728\u67e5\u8d44\u6599\u7684\u8fc7\u7a0b\u4e2d\u53d1\u73b0\uff0c\u6b27\u6d32\u7684ASMFs\u6700\u521d\u7684\u8ba8\u8bba\u6587\u4ef6\u662f\u57282006\u5e74\uff0cCEPs\u6700\u5f00\u59cb\u7684\u8d77\u6e90\uff0c\u4e5f\u5f97\u52302001\u5e74(EDQM\u662f\u6839\u636e2001\/83 EC\u6307\u4ee4\u6765\u8fdb\u884cCEPs\u8ba4\u8bc1\u7684)\u3002\u800c\u7f8e\u56fd\u7684DMF\u6307\u5357\uff0c1989\u5e74\u5c31\u5f00\u59cb\u5b9e\u65bd\u4e86\uff0c\u5e76\u4e14\u4e00\u76f4\u5ef6\u7eed\u5230\u73b0\u5728\u3002\u8bf4\u8d77\u6d3b\u6027\u7269\u8d28\u4e3b\u6587\u4ef6\uff0c\u7f8e\u56fdDMF\u5236\u5ea6\u662f\u9996\u521b\uff0c\u6b27\u6d32\u4ee5\u53ca\u5176\u4ed6\u540e\u7eed\u7684\u52a0\u62ff\u5927\u3001\u6fb3\u5927\u5229\u4e9a\u7b49\uff0c\u90fd\u662f\u5728\u4eff\u7f8e\u56fd\u7684DMF\u5236\u5ea6\u3002
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DMF\u5236\u5ea6\u786e\u5b9e\u662f\u4e00\u4e2a\u521b\u65b0\uff0c\u5bf9\u6d3b\u6027\u7269\u8d28\u3001\u8f85\u6599\u3001\u836f\u5305\u6750\u7684\u751f\u4ea7\u5546\uff08DMF\u7684\u6301\u6709\u8005\uff09\u3001FDA\u548c\u5236\u5242\u4e0a\u5e02\u7533\u8bf7\u8005\u90fd\u6709\u597d\u5904\uff1a\u4e00\u662f\u6d3b\u6027\u7269\u8d28\u6216\u8f85\u6599\u6216\u836f\u5305\u6750\u7684\u751f\u4ea7\u5546\u53ea\u9700\u8981\u5411FDA\u9012\u4ea4\u8d44\u6599\uff0c\u4e0d\u9700\u8981\u628a\u8d44\u6599\u7ed9\u5236\u5242\u4e0a\u5e02\u7533\u8bf7\u8005\uff0c\u8fd9\u6837\u4fdd\u62a4\u4e86\u6d3b\u6027\u7269\u8d28\u6216\u8f85\u6599\u6216\u836f\u5305\u6750\u7684\u751f\u4ea7\u5546\u7684\u5546\u4e1a\u673a\u5bc6\u3002\u4e8c\u662f\u4e0d\u540c\u5236\u5242\u4e0a\u5e02\u7533\u8bf7\u8005\u7528\u5230\u76f8\u540c\u7684DMF\uff0cFDA\u4e5f\u4e0d\u9700\u8981\u591a\u6b21\u5ba1\u8bc4\uff0c\u8282\u7ea6\u4e86\u5ba1\u8bc4\u8d44\u6e90\u3002\u4e09\u662f\u5bf9\u5236\u5242\u4e0a\u5e02\u7533\u8bf7\u8005\u6765\u8bf4\u53ef\u4ee5\u628a\u4e3b\u8981\u7cbe\u529b\u653e\u5728\u5236\u5242\u4e0a\u3002\u6240\u4ee5\u4ecb\u7ecd\u6d3b\u6027\u7269\u8d28\u7684\u4e3b\u6587\u4ef6\uff0c\u4e0d\u5f97\u4e0d\u4ecb\u7ecd\u7f8e\u56fdDMF\u5236\u5ea6\u3002<\/p>\n

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DMF\u7b80\u4ecb<\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/section>\n


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\u4e00\u5957DMF(Drug Master File)\u6587\u4ef6\u662f\u9012\u4ea4\u7ed9FDA\u7684\uff0c\u5305\u542b\u5728\u751f\u4ea7\u3001\u64cd\u4f5c\u3001\u5305\u88c5\u548c\u50a8\u5b58\u4e00\u4e2a\u6216\u591a\u4e2a\u4eba\u7528\u836f\u8fc7\u7a0b\u4e2d\uff0c\u4f7f\u7528\u5230\u7684\u5382\u623f\uff0c\u64cd\u4f5c\u6d41\u7a0b\u6216\u4f7f\u7528\u7684\u7269\u8d28\u7684\u4fdd\u5bc6\u7ec6\u8282\u4fe1\u606f\u3002DMF\u4e0d\u662f\u6cd5\u5f8b\u6cd5\u89c4\u8981\u6c42\u9012\u4ea4\u7684\uff0c\u800c\u662f\u4f01\u4e1a\u51b3\u5b9a\u8981\u4e0d\u8981\u9012\u4ea4\u3002DMF\u5305\u542b\u7684\u5185\u5bb9\u53ef\u652f\u6301: \u4e34\u5e8a\u7814\u7a76\u7533\u8bf7(Investigational New Drug, IND), \u65b0\u836f\u6ce8\u518c(New Drug Application,NDA) \u548c\u4eff\u5236\u836f\u6ce8\u518c(Abbreviated New Drug Application, ANDA), \u53e6\u4e00\u4e2aDMF\uff0c\u6216\u662f\u51fa\u53e3\u7533\u8bf7\u6ce8\u518c(Export Application),\u4ee5\u53ca\u8fd9\u4e9b\u7533\u8bf7\u6ce8\u518c\u7684\u53d8\u66f4\u6216\u662f\u8865\u5145\u7533\u8bf7\u3002<\/p>\n

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DMF\u6ce8\u518c<\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/section>\n


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DMF\u6709\u4e94\u79cd\u7c7b\u578b\uff0c\u5176\u4e2d\uff1a2000\u5e74\u540e\uff0cI\u578bDMF  FDA\u5df2\u4e0d\u518d\u63a5\u53d7\u3002
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I \u578b\uff1a\u7ec4\u7ec7\u4e0e\u4eba\u5458\u3001\u8bbe\u65bd\u4e0e\u8bbe\u5907\u548c\u6807\u51c6\u64cd\u4f5c\u7a0b\u5e8f\uff1b<\/p>\n

II\u578b\uff1a\u539f\u6599\u836f\u3001\u4e2d\u95f4\u4ea7\u54c1\u53ca\u5176\u539f\u6599\uff0c\u5236\u5242\u836f\uff1b<\/p>\n

III\u578b\uff1a\u5305\u88c5\u6750\u6599\u2014\u2014\u5bb9\u5668\uff1b<\/p>\n

IV\u578b\uff1a\u8d4b\u5f62\u5242\uff0c\u7740\u8272\u5242\uff0c\u9999\u6599\u53ca\u5176\u539f\u6599\uff1b<\/p>\n

V\u578b\uff1a\u53ef\u88abFDA\u63a5\u53d7\u7684\u5176\u5b83\u4fe1\u606f\uff1b<\/p>\n

DMF\u7684\u72b6\u6001\u5206\u6210\u4e24\u79cd\uff0c<\/p>\n

\u201cA\u201d=active\uff1a\u6fc0\u6d3b\u72b6\u6001\uff0c\u610f\u5473\u7740DMF\u53ef\u7528\uff0c\u6ca1\u6709\u5173\u95ed\uff1b<\/p>\n

 \u201cI\u201d=Inactive\uff1a\u672a\u6fc0\u6d3b\u72b6\u6001\uff0c\u610f\u5473\u7740DMF\u88abDMF\u6301\u6709\u8005\u6216FDA\u5173\u95ed\u3002<\/p>\n

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\u91cd\u65b0\u6fc0\u6d3b<\/span>DMF<\/span><\/strong><\/span><\/p>\n


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\u672a\u6fc0\u6d3b\u7684DMF\uff08\u6216\u662f\u5173\u95ed\u7684DMF\uff09\u60f3\u53d8\u6210\u6fc0\u6d3b\u72b6\u6001\uff0c\u53ea\u80fd\u901a\u8fc7\u9012\u4ea4\u6fc0\u6d3b\u7533\u8bf7\u6765\u6fc0\u6d3b\u3002\u6fc0\u6d3b\u7533\u8bf7\u5e94\u5305\u542b\u4e00\u6574\u5957DMF\u6587\u4ef6\uff0c\u5e76\u7b26\u5408\u73b0\u884c\u6cd5\u89c4\u3002\u5c01\u9762\u4fe1\u5fc5\u987b\u6ce8\u660e\u662f\u6fc0\u6d3b\u7533\u8bf7\u3002\u6216\u8005DMF\u6301\u6709\u8005\u53ef\u4ee5\u9012\u4ea4\u4e00\u4e2a\u65b0\u7684DMF\u3002<\/p>\n

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FDA\u6bcf\u4e2a\u5b63\u5ea6\u5bf9DMF\u7684\u5217\u8868\u6e05\u5355\u8fdb\u884c\u66f4\u65b0\uff0c\u53ef\u5728\u5b98\u7f51\u627e\u5230Excel\u7248\u548cTXT\u7248\u7684\u5217\u8868\u3002\u76ee\u524dDMF\u6e05\u5355\u662f2016\u5e746\u670830\u65e5\u4e4b\u524d\u6536\u5230\u7684\u6587\u4ef6\uff0c\u786e\u8ba4\u63a5\u53d7\u4fe1\u51fd(acknowledgment letters)\u57282016\u5e747\u67086\u53f7\u4e4b\u524d\u53d1\u51fa\u3002<\/p>\n

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\u7b14\u8005\u5bf9\u8fd9\u4efd\u5217\u8868\u8fdb\u884c\u4e86\u7edf\u8ba1\u5206\u6790\uff0c\u622a\u6b622016\u5e74\u7b2c\u4e8c\u5b63\u5ea6\uff0c\u603b\u670929414\u4efdDMFs\uff0c\u5176\u4e2d52%\u5c5e\u4e8e\u672a\u6fc0\u6d3b\u72b6\u6001\u3002<\/p>\n


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\"\u5e72\u8d27<\/p>\n


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\u6ce8\uff1a\u88ab\u53d6\u6d88\u7684DMF\u53f7\uff0c\u9884\u5206\u914d\u7684DMF\u53f7\u548c\u5f85\u5b9a\u6216\u662f\u88ab\u5206\u914d\u5230\u5176\u4ed6\u4e2d\u7684DMF\u53f7\u4e0d\u5728DMF\u6e05\u5355\u4e2d\u3002DMF\u72b6\u6001\u4e0d\u4f20\u8fbe\u5176\u4ed6\u4fe1\u606f\uff0c\u4f8b\u5982DMF\u662f\u5426\u6280\u672f\u5ba1\u8bc4\u8fc7\uff0c\u6216\u8005\u662f\u4e0d\u662f\u6b63\u5728\u8fdb\u884c\u5b8c\u6574\u6027\u5ba1\u8bc4(Completeness Assessment); \u5982\u60f3\u8be2\u95eeDMF\u662f\u4e0d\u662f\u5728\u5b8c\u6574\u6027\u5ba1\u8bc4\u4e2d\uff0c\u53ef\u53d1\u9001\u90ae\u4ef6\u81f3DMFOGD@fda.hhs.gov, \u8fdb\u884c\u8be2\u95ee\u3002 \u5728\u6fc0\u6d3b\u7684DMF\u4e2d\uff0cII\u578bDMF\u6700\u591a\uff0c\u5360\u670970%\uff1bV\u578b\u6700\u5c11\uff0c\u53602%\uff1b<\/span><\/span><\/p>\n


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\"\u5e72\u8d27<\/p>\n


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DMF\u7684\u6ce8\u518c\u683c\u5f0f<\/span><\/strong><\/span><\/p>\n


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\u867d\u7136\u76ee\u524d\u4e3a\u6b62\uff0cDMF\u6ca1\u6709\u8981\u6c42\u7528\u7535\u5b50\u7248\uff0c\u4f46\u52302017\u5e745\u6708\u4efd\u540e\uff0c\u65b0\u9012\u4ea4\u7684DMF\u90fd\u8981\u7528eCTD\u683c\u5f0f\u9012\u4ea4\uff1b\u5982\u679c\u4e0d\u7528eCTD\u683c\u5f0f\u9012\u4ea4\uff0c\u5c06\u4f1a\u88abCDER\u62d2\u6536\u3002\u4e4b\u524d\u4e00\u76f4\u90fd\u7528\u7eb8\u8d28\u9012\u4ea4\u7684DMF\uff0c\u6ca1\u6709\u5f3a\u5236\u8981\u6c42\u4f7f\u7528eCTD\u683c\u5f0f\u3002<\/p>\n

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\u7535\u5b50\u7248\u7684DMF\u53ef\u901a\u8fc7FDA\u7684ESG\u9012\u4ea4(Eelectronic Submission Gateway). 10GB\u4ee5\u4e0b\u7684\u6ce8\u518c\u8d44\u6599\u90fd\u53ef\u901a\u8fc7ESG\u9012\u4ea4\uff0c\u5927\u90e8\u5206DMF\u90fd\u4e0d\u8d85\u8fc710GB\uff1bFDA\u9f13\u52b1DMF\u6301\u6709\u8005\u5c3d\u65e9\u83b7\u5f97ESG\u7684\u8d26\u53f7\u3002\u5bf9\u4e8e\u8d85\u8fc710GB\u7684\u6ce8\u518c\u8d44\u6599\uff0c\u53ef\u7528\u7269\u7406\u5a92\u4ecb\u9012\u4ea4\uff0c\u4f8b\u5982\u5149\u76d8\u7b49\u3002<\/p>\n

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\u57282017\u5e745\u6708\u4efd\u4e4b\u524d\uff0c\u4efb\u4f55\u65f6\u5019\uff0cDMF\u6301\u6709\u8005\u5747\u53ef\u9009\u62e9\u4ece\u76ee\u524d\u7684\u7eb8\u8d28DMF\u8f6c\u5230eCTD\u683c\u5f0f\u3002\u5982\u679cDMF\u6301\u6709\u8005\u51b3\u5b9a\u8f6c\u6210eCTD\u683c\u5f0f\uff0cDMF\u53f7 (DMF number)\u5c06\u4fdd\u6301\u4e0d\u53d8\u3002\u5982\u679cDMF\u53f7\u4e4b\u524d\u662f4\u4f4d\u6570\u7684\uff0c\u8981\u8f6c\u6210eCTD\u683c\u5f0f\uff0c\u9700\u5728\u524d\u9762\u8865\u5145\u4e24\u4e2a00\uff0c\u8fbe\u52306\u4f4d\u6570\u3002\u4f8b\u5982\uff0c\u7eb8\u8d28\u7248\u65f6\uff0cDMF\u53f7\u662f1234\uff0c\u8f6c\u6210eCTD\u65f6\uff0cDMF\u53f7\u4f4d001234\uff1b\u6b64\u5916\uff0cDMF\u6301\u6709\u8005\u51b3\u5b9a\u8f6c\u6210eCTD\u683c\u5f0f\uff0c\u5982\u679c\u56e0\u4e3a\u683c\u5f0f\u7684\u8f6c\u53d8\uff0cDMF\u7684\u5185\u5bb9\u9700\u8981\u8c03\u6574\u53d8\u66f4\uff0c\u8fd9\u4e9b\u8c03\u6574\u548c\u53d8\u66f4\u9700\u8981\u5728\u5c01\u9762\u4fe1(Cover Letter)\u4e0a\u5199\u6e05\u695a\u3002<\/p>\n

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2017\u5e745\u6708\u4e4b\u524d\uff0c\u5bf9\u73b0\u884c\u7eb8\u8d28\u7248DMF\u7684\u6ce8\u518c\u8d44\u6599\uff0c\u9700\u8981\u4e24\u4efd\u7eb8\u8d28\u7248\uff1b\u5982\u679c\u6709DVD\u6216CD\u548c\u7eb8\u8d28\u7248\u7684\u6ce8\u518c\u8d44\u6599\u4e00\u8d77\u9012\u4ea4\uff0cDVD\u6216\u662fCD\u4e0d\u88ab\u63a5\u53d7\u3002\u901a\u8fc7e-mail\u9012\u4ea4\u7684\u6ce8\u518c\u8d44\u6599\u4e5f\u4e0d\u88ab\u63a5\u53d7\u3002\u7eb8\u8d28\u7248\u7684\u6ce8\u518c\u8d44\u6599\u53ef\u4ee5\u53cc\u9762\u6253\u5370\u3002<\/span><\/p>\n

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\u9884\u5206\u914d<\/span>DMF<\/span><\/strong>\u53f7<\/span><\/strong><\/span><\/p>\n


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DMF\u6301\u6709\u8005\u5e0c\u671b\u7535\u5b50\u9012\u4ea4DMF\u6587\u4ef6\u5fc5\u987b\u4e8b\u5148\u83b7\u53d6\u4e00\u4e2aDMF\u9884\u5206\u914d\u53f7\u3002\u7eb8\u8d28\u9012\u4ea4DMF\u7684\u6301\u6709\u8005\u4e5f\u53ef\u83b7\u53d6\u3002<\/p>\n


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\u516c\u53f8\u5982\u679c\u60f3\u83b7\u5f97V\u578b\u7684DMF\u53f7\uff0c\u5e94\u83b7\u5f97DMF\u7684\u6e05\u6670\u7406\u7531(Clearance);\u5982\u679c\u6ca1\u6709\u83b7\u5f97Clearance,\u5728\u7533\u8bf7\u83b7\u5f97DMF\u53f7\u65f6\uff0c\u5e94\u5728\u8bf4\u660e\u6e05\u695aDMF\u6240\u5305\u542b\u7684\u5185\u5bb9\uff0c\u4f8b\u5982\u65e0\u83cc\u5904\u7406\u8bbe\u65bd\u7533\u8bf7\u4e2dCMC\uff08Chemistry, Manufacturing and Controls\uff09\u90e8\u5206\u7684\u8d44\u6599\u7f16\u5199\u683c\u5f0f\u3002<\/p>\n

 <\/p>\n

DMFs\u5e94\u8be5\u6839\u636eCTD\u683c\u5f0f\u6765\u7f16\u5199\u3002MaPP(Manual of Policies and Procedures) \u4e2d\u5305\u542b\u4e86\u5ba1\u8bc4\u8005\u7684\u804c\u8d23\u3002\u5ba1\u8bc4\u8005\u6309\u7167Question-based Review(QbR) format \u6765\u5ba1\u8bc4\u3002\u6240\u6709II\u578bDMF\u4e2d\u7684\u539f\u6599\u836f\u548c\u5236\u5242\u90e8\u5206\uff0c\u4e5f\u53ef\u53c2\u8003QbR\u683c\u5f0f\u6765\u5199\uff0c\u5c3d\u7ba1\u8fd9\u5e76\u4e0d\u662f\u8981\u6c42\u3002<\/p>\n


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\u8f6c\u6210<\/span>CTD<\/span><\/strong>\u683c\u5f0f<\/span><\/strong><\/span><\/p>\n


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\u516c\u53f8\u53ef\u80fd\u628a\u73b0\u884c\u7684\u7eb8\u8d28\u7684\u3001\u975eCTD\u683c\u5f0f\u7684\u6587\u4ef6\u8f6c\u6210\u7eb8\u8d28\u7684CTD\u683c\u5f0f\u3002\u5728\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0c\u5efa\u8baeDMF\u6301\u6709\u8005\u9012\u4ea4\u8865\u5145\u7533\u8bf7\uff0c\u5305\u542b\u6240\u6709CTD\u683c\u5f0f\u4e2d\u7684section\uff0c\u8fd9\u4e9b\u5185\u5bb9\u5728\u4e4b\u524d\u7684\u975eCTD\u683c\u5f0f\u4e2d\u4e5f\u90fd\u5305\u542b\u3002\u6bcf\u4e2a\u90e8\u5206\u7684\u4fe1\u606f\u90fd\u5e94\u8be5\u662f\u5b8c\u6574\u7684\u548c\u6700\u65b0\u7684\u3002\u5bf9\u4e8e\u539f\u6599\u836f(drug substance)\u548c\u8f85\u6599\u9700\u8981\u9012\u4ea43.2.S\u548c2.3.S\u6a21\u5757\u7684\u8d44\u6599\u3002\u5bf9\u4e8e\u5236\u5242\uff0c\u9700\u8981\u9012\u4ea4\u6240\u67093.2.P\u548c2.3.P\u6a21\u5757\u8d44\u6599\u3002\u5982\u56e0\u683c\u5f0f\u6539\u53d8\u5f15\u8d77\u4e86DMF\u6280\u672f\u6587\u4ef6\u7684\u53d8\u5316\uff0c\u4f8b\u5982\u589e\u52a0\u65b0\u7684\u4fe1\u606f\uff0c\u65b0\u683c\u5f0f\u6ce8\u518c\u7684\u5c01\u9762\u4fe1\u5e94\u8bf4\u660e\u54ea\u4e9b\u6280\u672f\u65b9\u9762\u6709\u6539\u53d8\u3002<\/p>\n


<\/p>\n


<\/p>\n

\u6c9f\u901a\u6e20\u9053<\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/section>\n


<\/p>\n


<\/p>\n

1)  \u6240\u6709DMFs\u7684\u95ee\u9898\u6216\u610f\u89c1\u53ef\u53d1\u9001\u81f3dmfquestion@cder.fda.gov,\u9664\u975eDMFs\u5728GDUFA\u4e0b\u7684\u95ee\u9898\u7684\uff0c\u8fd9\u65b9\u9762\u7684\u95ee\u9898\u53ef\u53d1\u90ae\u4ef6\u81f3\uff1aDMFOGD@FDA.hhs.gov<\/p>\n


<\/p>\n

2)  \u6240\u6709\u7684\u95ee\u9898\uff0c\u5728\u90ae\u4ef6\u7684subject \u4e0a\u9700\u8981\u5199\u6e05\u695a\uff0c\u90ae\u4ef6\u7684\u5927\u6982\u5185\u5bb9\u4ee5\u53ca\u4e0eDMFs\u7684\u5173\u7cfb.\u56e0\u4e3a\u90ae\u7bb1\u7ecf\u5e38\u53d7\u5230\u5927\u91cf\u7684\u5783\u573e\u90ae\u4ef6\uff0c\u90ae\u4ef6subject\u662f\u7a7a\u767d\u7684\u6216\u65e0\u610f\u4e49\u7684\u6587\u5b57\u6216\u53ea\u6709\u4e00\u4e2a\u95ee\u53f7\uff0c\u90ae\u4ef6\u5c06\u4e0d\u4f1a\u88ab\u6253\u5f00\u3002<\/p>\n


<\/p>\n

3\uff09 \u5982\u679c\u8be2\u95ee\u67d0\u4e2a\u5177\u4f53\u7684DMF\uff0cDMF\u53f7\u9700\u8981\u5305\u542b\u5728\u90ae\u4ef6\u7684subject\u4e2d\u3002<\/p>\n


<\/p>\n

4\uff09 \u5176\u4ed6\u5173\u4e8eDMF\u7684\u95ee\u9898\uff0c\u5e94\u53d1\u9001\u5230CDER-OPQ-Inquiries@fda.hhs.gov.<\/p>\n


<\/p>\n

5)  \u5173\u4e8e\u8be2\u95ee\u62a5\u544a\u7684\u5206\u7c7b(reporting category)\u548c\u6279\u51c6\u4e86\u7684\u7533\u8bf7\u4e2dDMF\u6709\u53d8\u66f4\u7684\u95ee\u9898\uff0c\u4e5f\u5e94\u53d1\u9001\u5230\u4e0a\u9762\u7684\u90ae\u7bb1\u3002<\/p>\n


<\/p>\n


<\/p>\n

DMF\u5ba1\u8bc4<\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/section>\n


<\/p>\n


<\/p>\n

\u884c\u653f\u5ba1\u8bc4<\/span>(Administrative Review)<\/span><\/span><\/strong><\/span><\/p>\n


<\/span><\/strong><\/span><\/p>\n

FDA\u7684\u6587\u4ef6\u5ba4(document room)\u6536\u5230\u4efb\u4f55\u6ce8\u518c\u8d44\u6599\uff0c\u5305\u62ecDMF\u6587\u4ef6\uff0c\u90fd\u4e0d\u4f1a\u53d1\u51fa\u6536\u5230\u901a\u77e5\u3002\u6536\u5230\u8d44\u6599\u540e\uff0c\u539f\u59cb\u7684DMF\u6587\u4ef6\u8fdb\u884c\u884c\u653f\u5ba1\u8bc4\uff0c\u770b\u770b\u8d44\u6599\u5f62\u5f0f\u4e0a\u662f\u5426\u662f\u5b8c\u6574\u7684\u3002\u884c\u653f\u5ba1\u8bc4\u53ef\u80fd\u9700\u89812-3\u5468\u3002\u5982\u679cDMF\u6587\u4ef6\u901a\u8fc7\u4e86\u884c\u653f\u5ba1\u8bc4\uff0cFDA\u4f1a\u53d1\u51fa\u786e\u8ba4\u51fd(Acknowledgement Letter),\u901a\u77e5DMF\u6301\u6709\u8005DMF\u53f7\u3002\u8fd9\u4e4b\u540e\uff0cDMF\u7684\u72b6\u6001\u662f\u6fc0\u6d3b\u7684\u3002\u5982\u679c\u6ca1\u6709\u901a\u8fc7\u884c\u653f\u5ba1\u8bc4\uff0cFDA\u5c06\u4f1a\u901a\u77e5DMF\u6301\u6709\u8005DMF\u6709\u54ea\u4e9b\u7f3a\u9677\uff0c\u8fd9\u4e9b\u7f3a\u9677\u4fee\u6b63\u540e\uff0cDMF\u7684\u72b6\u6001\u624d\u80fd\u53d8\u6210\u6fc0\u6d3b\u3002<\/p>\n


<\/p>\n

\u6280\u672f\u5ba1\u8bc4<\/span> (Technical Review)<\/span><\/strong><\/span><\/p>\n


<\/span><\/p>\n

DMFs\u53ea\u6709\u5728\u4e0b\u9762\u60c5\u51b5\u4e0b\uff0c\u624d\u8fdb\u5165\u6280\u672f\u5ba1\u8bc4\uff1a<\/p>\n

1. DMF\u662f\u6fc0\u6d3b\u72b6\u6001.<\/p>\n

2. DMF\u6301\u6709\u8005\u9012\u4ea4\u4e86\u4e00\u5f0f\u4e24\u4efd\u6388\u6743\u4fe1(Letter of Authorization, LOA)(\u5982\u679c\u662f\u7eb8\u8d28\u7248\u9012\u4ea4)\uff1b\u5982\u679cDMF\u662f\u6309\u7167CTD\u683c\u5f0f\u6765\u5199\u7684\uff0c\u65e0\u8bba\u662f\u7535\u5b50\u7248\u8fd8\u662f\u7eb8\u8d28\u7248\uff0cLOA\u5e94\u8be5\u5305\u542b\u5728section 1.4.1\u4e2d\u3002LOA\u4e2d\u5e94\u5305\u542bDMF\u53f7(DMF number).<\/p>\n

3.DMF\u6301\u6709\u8005\u9012\u4ea4\u4e00\u4efdLOA\u7ed9\u6388\u6743\u65b9\uff08\u4e00\u822c\u4e3a\u5236\u5242\u751f\u4ea7\u8005\uff09\u3002<\/p>\n

4.\u6388\u6743\u65b9\u9012\u4ea4\u6ce8\u518c\u8d44\u6599\u7ed9FDA\uff0c\u6ce8\u518c\u8d44\u6599\u4e2d\u5305\u542b\u590d\u5236\u7684LOA\u3002\u590d\u5236\u7684LOA\u5e94\u5305\u542b\u5728section 1.4.2\u4e2d\u3002<\/p>\n

\u5b8c\u6574\u6027\u5ba1\u8bc4<\/span> (Complete Assessment)<\/span><\/strong><\/span><\/p>\n


<\/span><\/strong><\/span><\/p>\n

\u5728GDUFA (Generic Drug User Fee Action, \u4eff\u5236\u836f\u4ed8\u8d39\u8005\u6cd5\u6848 )\u4e2d\u89c4\u5b9a\u652f\u6301\u4eff\u5236\u836f\u7533\u8bf7\u7684 II\u578bDMF\u624d\u9700\u8981\u8fdb\u884c\u5b8c\u6574\u6027\u5ba1\u8bc4\u3002\u53c2\u89c1\u6307\u5357\u201dCompleteness Assessments for Type II API DMFs Under GDUFA\u201d(CA Guidance);<\/p>\n

 <\/p>\n

\u4eff\u5236\u836f\u4ed8\u8d39\u8005\u6cd5\u6848\u5305\u62ec\u4e86DMF\u8d39\u7528\u6761\u6b3e\uff0c\u5b8c\u6574\u6027\u5ba1\u8bc4\u4ee5\u53ca\u548cDMF\u6301\u6709\u8005\u7684\u4ea4\u6d41\u3002GDUFA\u53ea\u9002\u7528\u4e8e\u652f\u6301ANDA\u7533\u8bf7\u7684\u539f\u6599\u836f(Active Pharmaceutical Ingredients, APIs)II\u578bDMF\u3002GDUFA\u4e2d\u4e0d\u9002\u7528\u4e8e\u7684<\/span>II<\/span>\u578b<\/span>DMF<\/span>\uff0c\u5982\u4e0b\uff1a<\/span><\/p>\n

\u5176\u4ed6\u79cdII<\/span>\u578b\uff0c<\/span>IV<\/span>\u578b\u548c<\/span>V<\/span>\u578b\u7684<\/span>DMF<\/span>\uff1b<\/span><\/p>\n

 <\/p>\n

\u5176\u4ed6II\u578bDMFs:<\/p>\n

    \n
  1. \n

    \u4ec5\u652f\u6301NDAs\u6216INDs\uff1b<\/p>\n<\/li>\n

  2. \n

    API\u4e2d\u95f4\u4f53<\/p>\n<\/li>\n

  3. \n

    APIs\u5236\u5907\u8fc7\u7a0b\u4e2d\u7684\u7269\u8d28<\/p>\n<\/li>\n

  4. \n

    \u5236\u5242\u4e2d\u95f4\u4f53<\/p>\n<\/li>\n

  5. \n

     \u5236\u5242<\/p>\n<\/li>\n<\/ol>\n

    \u901a\u8fc7\u5b8c\u6574\u6027\u5ba1\u8bc4\u7684DMFs\u6709\u4e2aExcel\u8868\u683c\u53ef\u4ee5\u67e5\u8be2\uff0c\u5728FDA\u7f51\u7ad9\u4e0a\u53ef\u4ee5\u627e\u5230\u3002\u53ea\u6709\u5728\u8fd9\u5f20\u8868\u683c\u4e2d\u627e\u5230\u7684DMFs\u624d\u901a\u8fc7\u4e86\u5b8c\u6574\u6027\u5ba1\u8bc4\u3002\u76ee\u524d\u8fd9\u4e2aexcel\u8868\u683c\u6bcf\u5468\u66f4\u65b0\u4e00\u6b21\u3002<\/p>\n

     <\/p>\n

    GDUFA\u4e0b\u7684II\u578bDMF\u901a\u8fc7\u884c\u653f\u6027\u5ba1\u8bc4(Administrative Review)\u5e76\u4e14\u5df2\u7ecf\u6309\u7167\u7b26\u5408\u76f8\u5173\u89c4\u5b9a\uff0c\u5c06\u4f1a\u6392\u961f\u7b49\u5f85\u5b8c\u6574\u6027\u5ba1\u8bc4\u3002\u5b8c\u6574\u6027\u5ba1\u8bc4\u4e0d\u9700\u8981LOA\u3002\u5b8c\u6574\u6027\u5ba1\u8bc4\u6240\u9700\u8981\u7684\u65f6\u95f4\u8981\u770b\u5de5\u4f5c\u91cf\uff0c\u53ef\u80fd\u9700\u8981\u5f88\u591a\u5468\u3002<\/p>\n

     <\/p>\n

    \u6ce8\uff1a\u5ba1\u8bc4\u65f6DMFs\u6587\u4ef6\u5e94\u8be5\u662f\u6700\u65b0\u7684\uff0c\u6839\u636eDMFs\u6cd5\u89c4(21CRF 314.420(c)):<\/em><\/span><\/p>\n


    <\/em><\/span><\/p>\n

    \u4efb\u4f55\u589e\u52a0\uff0c\u6539\u53d8\u6216\u5220\u9664DMFs\u7684\u6587\u4ef6(\u9664\u975e\u662f\u6b64\u6cd5\u89c4\u4e2dparagraph(d)\u4e2d\u89c4\u5b9a\u7684) \u90fd\u9700\u9012\u4ea4\u4e00\u5f0f\u4e24\u4efd\u8d44\u6599\uff0c\u5e76\u5199\u4e0a\u6240\u5f71\u54cd\u7684DMF\u7684\u540d\u79f0\u3001\u53c2\u8003\u53f7(reference number)\u3001\u5377\u53f7\u548c\u9875\u7801\u4fe1\u606f\u3002<\/em><\/span><\/p>\n

     <\/em><\/span><\/p>\n

    DMF\u6307\u5357\u6587\u4ef6\u5efa\u8baeDMF\u6301\u6709\u8005\u4e00\u5e74\u66f4\u65b0\u4e00\u6b21DMFs\u3002\u4e3a\u4e86\u786e\u4fddDMFs\u6587\u4ef6\u662f\u6700\u65b0\u7684\uff0cFDA\u53d1\u51fa\u903e\u671f\u901a\u77e5\u4fe1\u51fd(Overdue Notification Letter, ONLs)\u7ed9DMF\u6301\u6709\u8005\uff0c\u5982\u679cDMF\u6301\u6709\u8005\u5728\u8fc7\u53bb36\u4e2a\u6708\u90fd\u6ca1\u6709\u9012\u4ea4\u5e74\u62a5\u3002\u5982\u679cDMF\u6301\u6709\u8005\u572890\u5929\u5185\uff0c\u6ca1\u6709\u5bf9FDA\u7684\u903e\u671f\u901a\u77e5\u51fd\u56de\u590d\uff0cFDA\u5c06\u4f1a\u5173\u95edDMF\u3002<\/em><\/span><\/p>\n


    <\/p>\n


    <\/p>\n

    \u5404\u7c7b\u578bDMF\u76f8\u5173\u6307\u5357<\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/section>\n


    <\/p>\n

     <\/span><\/p>\n

    I<\/span><\/strong>\u578b<\/span><\/strong><\/span><\/p>\n


    <\/span><\/strong><\/span><\/p>\n

    \u4ece2000\u5e74\u540e\uff0c\u4e0d\u518d\u63a5\u53d7I\u578bDMFs\u3002II\u578b\u3001III\u578b\u548cIV\u578bDMFs\u4e0d\u9700\u8981\u628a\u8bbe\u5907\u3001\u4eba\u5458\u6216\u662f\u603b\u4f53\u7684\u64cd\u4f5c\u6d41\u7a0b\u5305\u542b\u5728DMFs\u91cc\u9762\u3002\u53ea\u9700\u8981\u5305\u542bDMF\u6301\u6709\u8005\u7684\u5730\u5740\u3001\u751f\u4ea7\u5730\u5740\u548c\u8054\u7cfb\u4eba\u7684\u5730\u5740\u4fe1\u606f\u7b49\u3002
    <\/p>\n


    <\/p>\n

    II\u578b \u539f\u6599\u836f\u548c\u539f\u6599\u836f\u4e2d\u95f4\u4f53<\/span><\/strong><\/span><\/p>\n

     <\/span><\/p>\n

    \u53c2\u8003\u6307\u5357\uff1a<\/p>\n

    1\uff09”Guidance for  Industry M4Q: The CTD – Quality”.<\/p>\n

    2\uff09Guidance for Industry: ANDAs:  Stability Testing of Drug Substances and Products: Questions and Answers DRAFT GUIDANCE<\/p>\n

    3) GDUFA<\/p>\n

    4) ICH \u6307\u5357\uff1aQ11 Development and Manufacture of Drug Substances<\/p>\n

     <\/p>\n

      III<\/span><\/strong>\u578b \u5305\u88c5\u6750\u6599\u2014\u5bb9\u5668<\/span><\/strong><\/span><\/p>\n


    <\/span><\/strong><\/span><\/p>\n

    \u53c2\u8003\u7684\u6307\u5357\uff1a<\/p>\n

    1\uff09Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics:  Chemistry, Manufacturing, and Controls Documentation<\/p>\n

    2\uff09MAPP 5015.5  CMC Reviews of Type III DMFs for Packaging Materials <\/p>\n

     <\/p>\n

    III\u578bDMF\u5e94\u7528CTD\u683c\u5f0f\u6765\u7f16\u5199\u3002\u5355\u4e2a\u7684\u90e8\u4ef6(Single components)\u548c\u6784\u5efa\u6750\u6599(materials of construction) \u5e94\u6309\u7167\u539f\u6599\u836f\u683c\u5f0f\u6765\u7f16\u5199\u3002\u4f8b\u5982,\u751f\u4ea7\u5236\u9020\u8fc7\u7a0b\u5e94\u5305\u542b\u5728S.2\u91cc\u9762\u3002\u7ec4\u88c5\u7684\u5305\u88c5\u7cfb\u7edf(Assembled container closure systems)\u53ef\u4f5c\u4e3a\u5236\u5242\u7684\u683c\u5f0f\u6765\u5199\uff0c\u4f8b\u5982\u6784\u5efa\u6750\u6599\u53ef\u5199\u5728P.1\u91cc\u9762 (3.2.p.1: description and composition of the drug product), \u6700\u7ec8\u5305\u88c5\u6750\u6599\u7684\u653e\u884c\u6807\u51c6\u53ef\u5305\u542b\u5728P.5(3.2.P.5: control of drug product)\u4e2d\u3002<\/p>\n

     <\/p>\n

     IV<\/strong><\/span>\u578b\uff1a\u8d4b\u5f62\u5242\uff0c\u7740\u8272\u5242\uff0c\u9999\u6599\u53ca\u5176\u539f\u6599<\/span><\/strong><\/span><\/p>\n


    <\/span><\/p>\n

    \u53c2\u8003\u7684\u6307\u5357\uff1a<\/p>\n

    1\uff09DMF Guidance  <\/p>\n

    2\uff09Guidance for Industry: Nonclinical Studies for the Safety Evaluation of PharmaceuticaExcipients\u201d\uff08\u5982\u6709\u6bd2\u7406\u7814\u7a76\u7684CMC\u4fe1\u606f\u5305\u542b\u5728IV\u578b\u7684DMF\u4e2d\uff09<\/p>\n

     <\/p>\n

    IV\u578bDMF\u5982\u53ea\u5305\u542b\u5355\u4e00\u7684\u7269\u8d28\uff0c\u53ef\u7528CTD\u4e2d\u539f\u6599\u836f\u7684\u683c\u5f0f\u6765\u5199\uff1b\u5982\u5305\u542b\u7684\u662f\u6df7\u5408\u7269\uff0c\u4f8b\u5982\u9999\u6599\u7684\u6df7\u5408\u7269\uff0c\u53ef\u7528CTD\u4e2d\u7684\u5236\u5242\u683c\u5f0f\u6765\u5199\u3002\u5982\u679c\u8d44\u6599\u4e2d\u5305\u542b\u6bd2\u7406\u7814\u7a76\u7684CMC\u4fe1\u606f\uff0c\u6bd2\u6027\u7814\u7a76\u7684CMC\u4fe1\u606f\u5e94\u5305\u542b\u5728\u53e6\u5916\u7684\u4e00\u5377\u6216\u51e0\u5377\u4e2d\u3002\u5c3d\u7ba1\u6700\u597d\u662f\u628a\u72ec\u7acb\u7814\u7a76\u7684CMC\u4fe1\u606f\u4f5c\u4e3aV\u578bDMF\u6765\u9012\u4ea4\u3002\u5728\u7535\u5b50\u9012\u4ea4\u7684\u8f85\u6599DMF\u4e2d\uff0c\u5173\u4e8e\u6bd2\u6027\u7814\u7a76\u7684\u4fe1\u606f\u5e94\u8be5\u5305\u542b\u5728\u5408\u9002\u7684\u6a21\u5757\u4e2d\u3002<\/p>\n

     <\/p>\n

    V<\/span><\/strong>\u578b\uff1a\u53ef\u88ab<\/span>FDA<\/span><\/strong>\u63a5\u53d7\u7684\u5176\u5b83\u4fe1\u606f<\/span><\/strong><\/span><\/p>\n


    <\/p>\n

    \u53c2\u8003\u7684\u6307\u5357\uff1a<\/p>\n

    1\uff0921 CFR 314.420(a)<\/p>\n

    2\uff09Guidance  for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products<\/p>\n

     <\/p>\n

    \u6839\u636e\u6cd5\u4ee4\uff0cDMF\u6301\u6709\u8005\u5982\u679c\u60f3\u7533\u8bf7V\u578bDMF\uff0c\u5fc5\u987b\u7ed9FDA\u6e05\u6670\u7684\u7406\u7531(obtain clearance from FDA)(\u9664\u4e86\u4e0a\u8ff0\u7b2c\u4e8c\u4e2a\u6307\u5357\u4e2d\u7684\u65e0\u83cc\u5904\u7406\u8bbe\u65bd)\u3002\u6f5c\u5728\u7684V\u578bDMF\u6301\u6709\u8005\u5e94\u8be5\u5c06\u4ed6\u4eec\u7684\u8bf7\u6c42\u53d1\u9001\u5230dmfquestion@cder.fda.gov,<\/p>\n


    <\/p>\n

    \u5305\u62ec\u4e0b\u9762\u7684\u5185\u5bb9\uff1a<\/p>\n

    1. \u7533\u8bf7V\u578bDMF\u7684\u5fc5\u8981\u6027<\/p>\n

    2. \u62df\u5b9a\u7684DMF\u540d\u79f0<\/p>\n

    3. \u8fd9\u4e9b\u4fe1\u606f\u4e0d\u80fd\u5305\u542b\u5728IND\uff0cNDA\u6216\u662fANDA\u4e2d\u7684\u7406\u7531
    <\/p>\n


    <\/p>\n

    \u672c\u6587\u6765\u6e90\u4e3a\u516c\u4f17\u53f7iReg\uff0c\u8f6c\u53d1\u6587\u7ae0\u4ec5\u4ee3\u8868\u4f5c\u8005\u89c2\u70b9\u3002\u539f\u6587\u4e3a\u4e24\u7bc7\uff0c\u4e3a\u65b9\u4fbf\u9605\u8bfb\uff0c\u5c0f\u7f16\u5408\u4e8c\u4e3a\u4e00\u5e76\u8fdb\u884c\u91cd\u65b0\u6392\u7248\uff0c\u5982\u679c\u7248\u6743\u95ee\u9898\u8bf7\u8054\u7cfb\u5c0f\u7f16\u3002<\/span><\/p>\n

    \n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

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