{"id":80573,"date":"2019-02-15T00:00:50","date_gmt":"2019-02-26T08:04:18","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/80573\/"},"modified":"2019-02-26T16:04:21","modified_gmt":"2019-02-26T08:04:21","slug":"295c800634","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/80573\/","title":{"rendered":"FDA eCTD\u7533\u62a5\u6307\u5357\uff08\u4e2d\u82f1\u6587\uff09"},"content":{"rendered":"
\n

\u672c\u6b21\u4fee\u8ba2\u5185\u5bb9\uff1a<\/span><\/p>\n

January 2019  Section I. Introduction<\/span><\/p>\n

\u2022      Paragraph added describing rationale for extending timetable for Type III drug master file submissions in eCTD for an additional 12 months.<\/span><\/p>\n

Section III.B. Timetable for Implementation of Electronic Submission Requirements<\/span><\/p>\n

\u2022      Updated to reflect that the requirement for Type III drug master files to be filed electronically takes place 60 months after May 5, 2015.<\/span><\/p>\n

\u2022      Example of timetable updated to reflect actual timetable for the implementation of the electronic submissions requirement.<\/span><\/p>\n

2019<\/span>\u5e74<\/span>1<\/span>\u6708<\/span>    <\/span><\/span>\u7b2c<\/span>I<\/span>\u90e8\u5206<\/span>.<\/span>\u524d\u8a00<\/span><\/span><\/p>\n

\u2022      <\/span><\/span>\u589e\u52a0\u6bb5\u843d\u8bf4\u660e<\/span>III<\/span>\u7c7b<\/span>DMF<\/span>\u6587\u4ef6\u4ee5<\/span>eCTD<\/span>\u683c\u5f0f\u7533\u62a5\u7684\u65f6\u95f4\u8868\u5ef6\u8fdf<\/span>12<\/span>\u4e2a\u6708\u7684\u7406\u7531<\/span><\/span><\/p>\n

\u7b2c<\/span> <\/span>III.B<\/span>\u90e8\u5206<\/span>.<\/span>\u7535\u5b50\u63d0\u4ea4\u8981\u6c42\u5b9e\u65bd\u65f6\u95f4\u8868<\/span><\/span><\/p>\n

\u2022      <\/span><\/span>\u66f4\u65b0\u4ee5\u53cd\u6620<\/span>III<\/span>\u7c7b<\/span>DMF<\/span>\u7535\u5b50\u63d0\u4ea4\u8981\u6c42\u5c06\u5728<\/span>2015<\/span>\u5e74<\/span>5<\/span>\u6708<\/span>5<\/span>\u65e5\u4e4b\u540e<\/span>60<\/span>\u4e2a\u6708\u5b9e\u65bd<\/span><\/span><\/p>\n

\u2022      <\/span><\/span>\u66f4\u65b0\u65f6\u95f4\u8868\u4ee5\u53cd\u6620\u7535\u5b50\u7533\u62a5\u8981\u6c42\u7684\u5b9e\u9645\u5b9e\u65bd\u65f6\u95f4\u8868<\/span><\/span><\/p>\n


<\/p>\n

Providing Regulatory Submissions in Electronic Format \u2014 Certain Human Pharmaceutical Product  Applications and Related Submissions Using the eCTD Specifications<\/span><\/strong><\/p>\n

Guidance for Industry<\/span><\/strong><\/p>\n

\u884c\u4e1a\u6307\u5357\uff1a\u4f7f\u7528<\/span>eCTD<\/span>\u6807\u51c6\u91c7\u7528\u7535\u5b50\u683c\u5f0f\u63d0\u4ea4\u6ce8\u518c\u7533\u62a5<\/span><\/strong><\/span><\/p>\n

\u2014<\/span>\u7279\u5b9a\u4eba\u836f\u7533\u62a5\u548c\u76f8\u5173\u7533\u62a5\u8d44\u6599<\/span><\/strong><\/span><\/p>\n

I.     INTRODUCTION <\/span><\/span>\u524d\u8a00<\/span><\/p>\n

Under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), at least 24 months after the issuance of a final guidance document in which the Food and Drug Administration (FDA) has specified the electronic format for submitting submission types to the Agency, such content must be submitted electronically and in the format specified by FDA . This guidance and the technical specification documents it incorporates by reference  describe how sponsors and applicants mustorganize the content that they submit to the Agency electronically for all submission types under section 745A(a) of the FD&C Act.  In addition to this guidance and existing technical specification documents, further and more detailed technical instructions are included in a separate eCTD technical conformance guide.<\/span><\/p>\n

\u6839\u636e<\/span>FDCA<\/span>\u7b2c<\/span>745A(a)<\/span>\u6761\u6b3e\uff0c\u5728\u53d1\u5e03<\/span>FDA<\/span>\u6307\u5b9a\u7535\u5b50\u683c\u5f0f\u63d0\u4ea4\u7533\u62a5\u6587\u4ef6\u7684\u6700\u7ec8\u6307\u5357\u6587\u4ef6\u4e4b\u540e\u6700\u77ed<\/span>24<\/span>\u4e2a\u6708\uff0c\u6b64\u7c7b\u7533\u62a5\u5fc5\u987b\u91c7\u7528\u7535\u5b50\u65b9\u5f0f\u6309<\/span>FDA<\/span>\u6307\u5b9a\u7684\u683c\u5f0f\u63d0\u4ea4\u3002\u672c\u6307\u5357\u53ca\u5176\u53c2\u8003\u6587\u4ef6\u4e2d\u5305\u62ec\u7684\u6280\u672f\u6807\u51c6\u6587\u4ef6\u9610\u660e\u4e86\u627f\u529e\u4eba\u548c\u7533\u62a5\u4eba\u5fc5\u987b\u4ee5\u4f55\u65b9\u5f0f\u7ec4\u7ec7\u5176\u5c06\u4ee5\u7535\u5b50\u683c\u5f0f\u63d0\u4ea4\u7ed9<\/span>FDA<\/span>\u7684\u4f9d\u636e<\/span>FDCA<\/span>\u7b2c<\/span>745A(a)<\/span>\u6761\u6b3e\u5236\u4f5c\u7684\u6240\u6709\u7533\u62a5\u7c7b\u578b\u8d44\u6599\u5185\u5bb9\u3002\u9664\u4e86\u672c\u6307\u5357\u548c\u5df2\u6709\u6280\u672f\u6807\u51c6\u6587\u4ef6\u5916\uff0c\u5728\u53e6\u4e00\u4efd\u5355\u72ec\u7684<\/span>eCTD<\/span>\u6280\u672f\u5408\u89c4\u6307\u5357\u4e2d\u5305\u62ec\u6709\u66f4\u591a\u66f4\u8be6\u7ec6\u7684\u6280\u672f\u6307\u5bfc\u3002<\/span><\/span><\/p>\n

This guidance implements the electronic submission requirements of section 745A(a) of the FD&C Act for the electronic format of the content submitted in new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) to the Center for Drug Evaluation and Research (CDER) orthe Center for Biologics Evaluation and Research (CBER).  See section III. A of this document for more information regarding required submission types.  Submissions that are not submitted electronically and electronic submissions that are not in a format that FDA can process, review, and archive will not be filed or received, unless exempted from the electronic submission requirements.<\/span><\/p>\n

\u672c\u6307\u5357\u6267\u884c\u7684\u662f<\/span>FDCA<\/span>\u7b2c<\/span>745A(a)<\/span>\u6761\u6b3e\u7684\u7535\u5b50\u7533\u62a5\u8981\u6c42\uff0c\u5176\u9002\u7528\u4e8e\u5411<\/span>CDER<\/span>\u548c<\/span>CBER<\/span>\u63d0\u4ea4\u7684<\/span>NDA<\/span>\u3001<\/span>ANDA<\/span>\u3001\u7279\u5b9a<\/span>BLA<\/span>\u548c\u7279\u5b9a<\/span>IND<\/span>\u4e2d\u63d0\u4ea4\u7684\u5185\u5bb9\u7684\u7535\u5b50\u683c\u5f0f\u3002\u5173\u4e8e\u7533\u62a5\u7c7b\u578b\u8981\u6c42\u66f4\u591a\u4fe1\u606f\u53c2\u89c1\u672c\u6587\u4ef6\u7b2c<\/span>III.A<\/span>\u90e8\u5206\u3002\u9664\u514d\u9664\u7535\u5b50\u7533\u62a5\u8981\u6c42\u8005\u5916\uff0c\u51e1\u91c7\u7528<\/span>FDA<\/span>\u4e0d\u53ef\u5904\u7406\u3001\u5ba1\u6838\u548c\u5f52\u6863\u7684\u683c\u5f0f\u63d0\u4ea4\u7684\u7535\u5b50\u7533\u62a5\u8d44\u6599\u548c\u975e\u7535\u5b50\u683c\u5f0f\u63d0\u4ea4\u7684\u7533\u62a5\u8d44\u6599\u5c06\u88ab\u62d2\u6536\u6216\u62d2\u7edd\u7acb\u5377\u3002<\/span><\/span><\/p>\n

The version of this guidance published on May 5, 2015 provided a timetable of 24months after issuance of the final guidance for the initial implementation ofthe electronic submission requirement for NDAs, ANDAs, BLAs, and master files,and 36 months for commercial INDs. The timetable indicated that NDAs, BLAs, ANDAs, and master files were to be submitted electronically in eCTD format starting on May 5, 2017 (May 5, 2018 for commercial INDs).<\/span><\/p>\n

2015<\/span>\u5e74<\/span>5<\/span>\u6708<\/span>5<\/span>\u65e5\u53d1\u5e03\u7684\u672c\u6307\u5357\u7248\u672c\u4e2d\u7684\u6709\u4e00\u4e2a\u65f6\u95f4\u8868\uff0c\u8981\u6c42\u5728\u7b7e\u53d1\u6700\u7ec8\u6307\u5357\u4e4b\u540e<\/span>24<\/span>\u4e2a\u6708<\/span>NDA<\/span>\u3001<\/span>ANDA<\/span>\u3001<\/span>BLA<\/span>\u548c\u4e3b\u6587\u4ef6\u5f00\u59cb\u5b9e\u65bd\u7535\u5b50\u7533\u62a5\u8981\u6c42\uff0c\u5546\u4e1a<\/span>IND<\/span>\u5728\u7b7e\u53d1\u540e<\/span>36<\/span>\u4e2a\u6708\u5b9e\u65bd\u3002\u65f6\u95f4\u8868\u663e\u793a<\/span>NDA<\/span>\u3001<\/span>BLA<\/span>\u3001<\/span>ANDA<\/span>\u548c\u4e3b\u6587\u4ef6\u81ea<\/span>2017<\/span>\u5e74<\/span>5<\/span>\u6708<\/span>5<\/span>\u65e5\u5f00\u59cb\u4ee5<\/span>eCTD<\/span>\u683c\u5f0f\u63d0\u4ea4\u3002<\/span><\/span><\/p>\n

FDA determined, in response to industry comments and internal review, that it was appropriate to extend the required date to submit master files in electronic eCTD format by 1 year to May 5, 2018. Among other factors, FDA recognized that there were challenges with submission of master files in eCTD format, and eCTD uptake data for masterfiles indicated that adhering to the May 5, 2017 date could have led to high rejection rates of master files and thus slower FDA review processes, and, therefore, potential unnecessary delay in the review of some drug applications.<\/span><\/p>\n

\u4e3a\u54cd\u5e94\u4f01\u4e1a\u5efa\u8bae\u548c\u5185\u90e8\u5ba1\u6838\uff0c<\/span>FDA<\/span>\u51b3\u5b9a\u9002\u5f53\u5ef6\u540e\u4ee5<\/span>eCTD<\/span>\u683c\u5f0f\u63d0\u4ea4<\/span>DMF<\/span>\u7684\u65f6\u95f4\u4e00\u5e74\u81f3<\/span>2018<\/span>\u5e74<\/span>5<\/span>\u6708<\/span>5<\/span>\u65e5\u3002\u9664\u4e86\u5176\u5b83\u56e0\u7d20\u5916\uff0c<\/span>FDA<\/span>\u4ea6\u8ba4\u8bc6\u5230\u4ee5<\/span>eCTD<\/span>\u683c\u5f0f\u63d0\u4ea4<\/span>DMF<\/span>\u5177\u6709\u6311\u6218\u6027\uff0c<\/span>DMF<\/span>\u7684<\/span>eCTD<\/span>\u63d0\u53d6\u6570\u636e\u663e\u793a\u575a\u6301\u8981\u6c42<\/span>2017<\/span>\u5e74<\/span>5<\/span>\u6708<\/span>5<\/span>\u65e5\u6267\u884c\u8be5\u8981\u6c42\u53ef\u80fd\u4f1a\u5bfc\u81f4\u8d85\u9ad8<\/span>DMF<\/span>\u62d2\u6536\uff0c\u56e0\u6b64\u62d6\u6162<\/span>FDA<\/span>\u7684\u5ba1\u8bc4\u6d41\u7a0b\uff0c\u4ece\u800c\u4e0d\u5fc5\u8981\u5730\u5ef6\u8fdf\u4e00\u4e9b\u5236\u5242\u7533\u62a5\u8d44\u6599\u7684\u5ba1\u8bc4\u3002<\/span><\/span><\/p>\n

Following the publication of that revision, FDA determined that application of the electronic submission requirement to Type III drug master files (DMFs) on May 5, 2018 could lead to high rejection rates of these submissions.  Further, because Type III DMFs typically provide information regarding packaging or packaging materials in support of NDAs, ANDAs, or BLAs, should submitters choose not to submit or to no longer support existing Type III DMFs, this could lead to drug supply interruptions. Finally, only a small portion of Type III DMFs submitted to the Agency require assessment by FDA staff in support of a marketing application; in most cases, the information needed to support approval is already present in the marketing application.  Given this, the burden onthe Agency of allowing non-eCTD submissions for Type III DMFs during the interim period was expected to be low. FDA has continued to recommend use ofthe eCTD format for Type III DMFs where possible, but the Agency issued a revision to this guidance to extend the implementation date for Type III DMFs until May 5, 2019. Since publication of version 5, which extended the implementation date to May 5, 2019, FDA determined that many of the concerns outlined above remain.  Therefore, the Agency is issuing a revision to this guidance to further extend the implementation date for Type III DMFs until May 5, 2020.<\/span><\/p>\n

\u5728\u8be5\u6b21\u4fee\u8ba2\u53d1\u5e03\u540e\uff0c<\/span>FDA<\/span>\u8ba4\u4e3a<\/span>III<\/span>\u7c7b<\/span>DMF<\/span>\u7535\u5b50\u7533\u62a5\u8981\u6c42\u5982\u679c\u5728<\/span>2018<\/span>\u5e74<\/span>5<\/span>\u6708<\/span>5<\/span>\u65e5\u5b9e\u65bd\uff0c\u53ef\u80fd\u4f1a\u5bfc\u81f4\u8be5\u7c7b\u7533\u62a5\u8f83\u9ad8\u7684\u62d2\u6536\u7387\u3002\u53e6\u5916\uff0c\u7531\u4e8e<\/span>III<\/span>\u7c7b<\/span>DMF<\/span>\u4e00\u822c\u63d0\u4f9b\u7684\u662f\u652f\u6301<\/span>NDA<\/span>\u3001<\/span>ANDA<\/span>\u6216<\/span>BLA<\/span>\u7684\u5305\u88c5\u6216\u5305\u6750\u4fe1\u606f\uff0c\u5982\u679c\u7533\u62a5\u8005\u9009\u62e9\u4e0d\u518d\u63d0\u4ea4\u6216\u4e0d\u518d\u652f\u6301\u73b0\u6709<\/span>III<\/span>\u7c7b<\/span>DMF<\/span>\uff0c\u5219\u53ef\u80fd\u4f1a\u5bfc\u81f4\u836f\u54c1\u4f9b\u5e94\u4e2d\u65ad\u3002\u6700\u540e\uff0c\u5728\u63d0\u4ea4\u7ed9<\/span>FDA<\/span>\u7684<\/span>III<\/span>\u7c7b<\/span>DMF<\/span>\u6587\u4ef6\u4e2d\u53ea\u6709\u5c11\u91cf\u8d44\u6599\u9700\u8981\u7531<\/span>FDA<\/span>\u5458\u5de5\u5ba1\u8bc4\u7528\u4e8e\u652f\u6301\u4e0a\u5e02\u7533\u62a5\u3002\u8003\u8651\u5230\u6b64\uff0c\u4e34\u65f6\u5141\u8bb8<\/span>III<\/span>\u7c7b<\/span>DMF<\/span>\u4ee5\u975e<\/span>eCTD<\/span>\u683c\u5f0f\u63d0\u4ea4\u4e0d\u4f1a\u7ed9<\/span>FDA<\/span>\u589e\u52a0\u592a\u591a\u5de5\u4f5c\u91cf\u3002<\/span>FDA<\/span>\u4ecd\u5efa\u8bae\u5c3d\u53ef\u80fd\u4f7f\u7528<\/span>eCTD<\/span>\u683c\u5f0f\u63d0\u4ea4<\/span>III<\/span>\u7c7b<\/span>DMF<\/span>\uff0c\u4f46<\/span>FDA<\/span>\u4fee\u8ba2\u4e86\u672c\u6307\u5357\u5c06<\/span>III<\/span>\u7c7b<\/span>DMF<\/span>\u7684\u5b9e\u65bd\u65e5\u671f\u5ef6\u8fdf\u81f3<\/span>2019<\/span>\u5e74<\/span>5<\/span>\u6708<\/span>5<\/span>\u65e5\u3002\u81ea\u4ece\u7b2c<\/span>5<\/span>\u7248\u53d1\u5e03\u5c06\u5b9e\u65bd\u65e5\u671f\u5ef6\u81f3<\/span>2019<\/span>\u5e74<\/span>5<\/span>\u6708<\/span>5<\/span>\u65e5\u4ee5\u6765\uff0c<\/span>FDA<\/span>\u8ba4\u4e3a\u4e0a\u8ff0\u5927\u90e8\u5206\u62c5\u5fe7\u4ecd\u7ee7\u7eed\u5b58\u5728\uff0c\u56e0\u6b64\uff0c<\/span>FDA<\/span>\u5728\u6b64\u7b7e\u53d1\u672c\u6307\u5357\u7684\u65b0\u4fee\u8ba2\uff0c\u8fdb\u4e00\u6b65\u5c06<\/span>III<\/span>\u7c7b<\/span>DMF<\/span>\u7684\u5b9e\u65bd\u65e5\u671f\u5ef6\u81f3<\/span>2020<\/span>\u5e74<\/span>5<\/span>\u6708<\/span>5<\/span>\u65e5\u3002<\/span><\/span><\/p>\n

\"FDA<\/p>\n

\"FDA<\/p>\n

\"FDA<\/p>\n

\"FDA<\/p>\n

\"FDA<\/p>\n

\n

\u82f1\u6587\u539f\u6587\u5b98\u7f51\u4e0b\u8f7d <\/span><\/p>\n

https:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM333969.pdf<\/span><\/p>\n

<\/mpcps><\/section>\n

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

\u672c\u6b21\u4fee\u8ba2\u5185\u5bb9\uff1a January 2019  Section I. Introduction \u2022&nb […]<\/p>\n","protected":false},"author":1,"featured_media":80574,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/80573"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=80573"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/80573\/revisions"}],"predecessor-version":[{"id":80580,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/80573\/revisions\/80580"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/80574"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=80573"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=80573"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=80573"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}