FDA eCTD申报指南(中英文)

FDA eCTD申报指南（中英文）本次修订内容：January 2019 Section I. Introduction Paragraph added describing rationale for extending timetable for Type III drug master file submissions in eCTD for an additional 12 months.Section III.B. Timetable for Implementation of Electronic Submission Requirements Updated to reflect that the requirement for Type III drug master files to be filed electronically takes place 60 months after May 5, 2015. Example of timetable updated to reflect actual timetable for the implementation of the electronic submissions requirement.2019年1月第I部分.前言增加段落说明III类DMF文件以eCTD格式申报的时间表延迟12个月的理由第III.B部分.电子提交要求实施时间表更新以反映III类DMF电子提交要求将在2015年5月5日之后60个月实施更新时间表以反映电子申报要求的实际实施时间表Providing Regulatory Submissions in Electronic Format Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD SpecificationsGuidance for Industry行业指南：使用eCTD标准采用电子格式提交注册申报特定人药申报和相关申报资料I. INTRODUCTION前言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.根据FDCA第745A(a)条款，在发布FDA指定电子格式提交申报文件的最终指南文件之后最短24个月，此类申报必须采用电子方式按FDA指定的格式提交。本指南及其参考文件中包括的技术标准文件阐明了承办人和申报人必须以何方式组织其将以电子格式提交给FDA的依据FDCA第745A(a)条款制作的所有申报类型资料内容。除了本指南和已有技术标准文件外，在另一份单独的eCTD技术合规指南中包括有更多更详细的技术指导。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.本指南执行的是FDCA第745A(a)条款的电子申报要求，其适用于向CDER和CBER提交的NDA、ANDA、特定BLA和特定IND中提交的内容的电子格式。关于申报类型要求更多信息参见本文件第III.A部分。除免除电子申报要求者外，凡采用FDA不可处理、审核和归档的格式提交的电子申报资料和非电子格式提交的申报资料将被拒收或拒绝立卷。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).2015年5月5日发布的本指南版本中的有一个时间表，要求在签发最终指南之后24个月NDA、ANDA、BLA和主文件开始实施电子申报要求，商业IND在签发后36个月实施。时间表显示NDA、BLA、ANDA和主文件自2017年5月5日开始以eCTD格式提交。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.为响应企业建议和内部审核，FDA决定适当延后以eCTD格式提交DMF的时间一年至2018年5月5日。除了其它因素外，FDA亦认识到以eCTD格式提交DMF具有挑战性，DMF的eCTD提取数据显示坚持要求2017年5月5日执行该要求可能会导致超高DMF拒收，因此拖慢FDA的审评流程，从而不必要地延迟一些制剂申报资料的审评。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.在该次修订发布后，FDA认为III类DMF电子申报要求如果在2018年5月5日实施，可能会导致该类申报较高的拒收率。另外，由于III类DMF一般提供的是支持NDA、ANDA或BLA的包装或包材信息，如果申报者选择不再提交或不再支持现有III类DMF，则可能会导致药品供应中断。最后，在提交给FDA的III类DMF文件中只有少量资料需要由FDA员工审评用于支持上市申报。考虑到此，临时允许III类DMF以非eCTD格式提交不会给FDA增加太多工作量。FDA仍建议尽可能使用eCTD格式提交III类DMF，但FDA修订了本指南将III类DMF的实施日期延迟至2019年5月5日。自从第5版发布将实施日期延至2019年5月5日以来，FDA认为上述大部分担忧仍继续存在，因此，FDA在此签发本指南的新修订，进一步将III类DMF的实施日期延至2020年5月5日。本次修订内容：January 2019 Section I. Introduction Paragraph added describing rationale for extending timetable for Type III drug master file submissions in eCTD for an additional 12 months.Section III.B. Timetable for Implementation of Electronic Submission Requirements Updated to reflect that the requirement for Type III drug master files to be filed electronically takes place 60 months after May 5, 2015. Example of timetable updated to reflect actual timetable for the implementation of the electronic submissions requirement.2019年1月第I部分.前言增加段落说明III类DMF文件以eCTD格式申报的时间表延迟12个月的理由第III.B部分.电子提交要求实施时间表更新以反映III类DMF电子提交要求将在2015年5月5日之后60个月实施更新时间表以反映电子申报要求的实际实施时间表Providing Regulatory Submissions in Electronic Format Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD SpecificationsGuidance for Industry行业指南：使用eCTD标准采用电子格式提交注册申报特定人药申报和相关申报资料I. INTRODUCTION前言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.根据FDCA第745A(a)条款，在发布FDA指定电子格式提交申报文件的最终指南文件之后最短24个月，此类申报必须采用电子方式按FDA指定的格式提交。本指南及其参考文件中包括的技术标准文件阐明了承办人和申报人必须以何方式组织其将以电子格式提交给FDA的依据FDCA第745A(a)条款制作的所有申报类型资料内容。除了本指南和已有技术标准文件外，在另一份单独的eCTD技术合规指南中包括有更多更详细的技术指导。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.本指南执行的是FDCA第745A(a)条款的电子申报要求，其适用于向CDER和CBER提交的NDA、ANDA、特定BLA和特定IND中提交的内容的电子格式。关于申报类型要求更多信息参见本文件第III.A部分。除免除电子申报要求者外，凡采用FDA不可处理、审核和归档的格式提交的电子申报资料和非电子格式提交的申报资料将被拒收或拒绝立卷。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).2015年5月5日发布的本指南版本中的有一个时间表，要求在签发最终指南之后24个月NDA、ANDA、BLA和主文件开始实施电子申报要求，商业IND在签发后36个月实施。时间表显示NDA、BLA、ANDA和主文件自2017年5月5日开始以eCTD格式提交。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.为响应企业建议和内部审核，FDA决定适当延后以eCTD格式提交DMF的时间一年至2018年5月5日。除了其它因素外，FDA亦认识到以eCTD格式提交DMF具有挑战性，DMF的eCTD提取数据显示坚持要求2017年5月5日执行该要求可能会导致超高DMF拒收，因此拖慢FDA的审评流程，从而不必要地延迟一些制剂申报资料的审评。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 as