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201505 FDA行业指南：提交电子法规申报---使用eCTD规范提交特定的人药申报和相关申报2015-05-20 09:53:29 | 分类：
Providing Regulatory Submissions in Electronic Format —Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry 行业指南 提交电子法规申报---使用eCTD规范提交特定的人药申报和相关申报 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) May 2015 Electronic Submissions Revision 3
RELATED DOCUMENTS 相关文件 Technical specifications associated with this guidance are provided as separate documents and are updated periodically. Documents cited within this guidance are provided at the end of this document. 与本指南相关的技术规范作为单独的文件提供，并会定期更新。在本指南中引用的文件在本文件的结尾给出。 For a complete listing of all documents and supportive files needed in order to submit electronically, refer to the eCTD Web page at 所有文件的完整列表，以及电子提交所需的支持性文件，请参见eCTD网站。
TABLE OF CONTENTS 目录 I. INTRODUCTION. 介绍 II. BACKGROUND. 背景 III. REQUIREMENT TO SUBMIT ELECTRONICALLY UNDER THIS GUIDANCE2 要求 A. Types of Submissions That Must Adhere to the Electronic Submission Requirement Described in This Guidance Document 申报类型 B. Timetable for Implementation of Electronic Submission Requirements 实施时间表 C. Types of Submissions That Are Exempted From the Electronic Submission Requirement Described in This Guidance Document 豁免类型 D. The eCTD Specifications 电子CTD规范 E. Pre-Submission Considerations 提交前考量 F. Submission Structure: Granularity, Files, and Folders 提交文件结构 G. File Formats and Versions 文件格式和版本 H. Document Lifecycle..文件生命周期 I. Summary of Clinical Efficacy and Summary of Clinical Safety .临床有效性综述和临床安全性综述 J. Datasets and Study Information..数据系列和研究资料 K. Transmitting Electronic Submissions .电子提交资料传送 L. FDA Forms .表格 M. Restrictions on Submission of Paper Copies 纸质提交限制 N. Receipt Date 接收日期 TECHNICAL SPECIFICATION DOCUMENTS INCORPORATED BY REFERENCE 引用技术标准 RELATED REFERENCES 相关文件
Providing Regulatory Submissions in Electronic Format —Certain Human Pharmaceutical Product[2] Applications and Related Submissions Using the eCTD Specifications 提交电子法规申报---使用eCTD规范提交特定的人药申报和相关申报 I. INTRODUCTION 概述 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[3]. This guidance and the technical specification documents it incorporates by reference[4] describe how sponsors and applicants must organize 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 will be included in a separate eCTD technical conformance guide. 根据联邦食品药品化妆品法案第745A(a)部分，在FDA签发电子提交规定最终指南文件后至少24个月，这些提交必须采用FDA指定格式进行电子提交。本指南和引用的技术规范描述了申报人应如何组织其按法案第745A(a)部分需要进行电子提交的内容。除本指南外和已有技术规范文件外，更多详细技术指示将包括在一个单独的eCTD技术一致性指南中。 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) or the 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. 本指南实施了FD&C法案第745A(a)部分的电子提交要求，包括提交给化药评审中心CDER，以及提交给生物药物评审中心CBER的新药申报NDA、简略新药申报ANDA、特定生物许可申报BLA、特定临床前新药申报IND。更多关于要求的提交类型，参见本文的第III.A部分。除豁免于电子提交要求者外，非电子提交资料，以及FDA不能处理、审核和存档的电子提交将不被记录和接受。 II. BACKGROUND 背景 In section 745A(a) of the FD&C Act, Congress granted explicit authorization to FDA to implement the statutory electronic submission requirements in guidance. Accordingly, as indicated by the use of the words must or required, this document is not subject to the usual restrictions in FDA’s good guidance practice (GGP) regulations, such as the requirement that guidances not establish legally enforceable responsibilities (see 21 CFR 10.115(d); see also the guidance for industry Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (745A(a) Implementation Guidance)). 在联邦食品药品化妆品法案第754A(a)部分中，议会赋予FDA权力实施本指南中法定电子提交要求。相应地，本指南中使用词语“必须”或“要求”时，并不像通常FDA的优良指南规范（GGP）规定中的受到限制，那些指南的要求并没有像本指南一样成为法定的强制要求（参见21CFR10.115(d)，也可参见行业指南“使用电子格式提交法规申报---根据联邦食品药品化妆品法案第745A(a)部分的提交”实施指南）。 To comply with the GGP regulations and make sure that regulated entities and the public understand that guidance documents are nonbinding, FDA guidances ordinarily contain standard language explaining that guidance documents should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. FDA is not including this standard language in this guidance document because it is not an accurate description of all of the effects of this guidance document. Insofar as this document specifies the format for electronic submissions, or provides “criteria for . . . exemptions” under section 745A(a) of the FD&C Act, it will have binding effect. 为了符合GGP法规，保证受管理的实体和公众理解非强制指南文件，FDA指南通常包括标准语言，解释指南只是作为建议，除非另有引用法规或法定要求。FDA在本指南中并没有包括这样的标准语言，因为对于本指南文件的所有效果来说，这并不是一个准确的描述。在本文件中指定电子提交的格式，或根据FD&C法案745A(a)部分提供“豁免…标准”，它是具有强制效果的。 III. REQUIREMENT TO SUBMIT ELECTRONICALLY UNDER THIS GUIDANCE 本指南对于电子提交的要求 Twenty-four (24) months after this guidance document is published, sponsors and applicants (you) must submit the content for which an electronic format for submission is specified in this guidance document in such electronic format. In other words, such submissions must be consistent with the requirements set forth below. 在本指南文件公布后24个月，申报人必须根据本指南文件中所要求的采用电子格式提交申报资料。换句话说，提交资料必须与以下要求保持一致。 A. Types of Submissions That Must Adhere to the Electronic Submission Requirement Described in This Guidance Document 必须符合本指南中电子提交要求的申报类型 Section 745A(a) of the FD&C Act applies to submissions under section 505(b), (i), or (j) of the FD&C Act and under section 351(a) or (k) of the Public Health Service (PHS) Act. These include the following submission types: 联邦食品药品化妆品法案的第745A（a）部分适用于根据联邦食品药品化妆品法案第505(b)(i)或(j)部分的提交，以及公众健康服务（PHS）法案第351(a)或(k)部分的提交。这些提交包括以下的提交类型： l Certain investigational new drug applications (INDs)[5][6] l 特定临床前新药申报 l New drug applications (NDAs) l 新药申报（NDA） l Abbreviated new drug applications (ANDAs) l 简略新药申报（ANDA） l Certain biologics license applications (BLAs)[7][8] l 特定生物许可申报（BLA） Section 745A(a) also applies to all subsequent submissions, including amendments, supplements, and reports, to the submission types identified above. 第745A(a)部分也适用于所有后续申报资料，包括增补、补充、报告，上述所有申报类型。 FDA considers master files to be submissions to an NDA, ANDA, BLA, or IND, and therefore to fall within the scope of requirements set forth in section 745A(a). These include new drug master files (DMFs) (21 CFR 314.420), new biological product files (BPFs) (21 CFR 601.51), and any amendments to or annual reports on previously submitted DMFs or BPFs. This guidance also applies to submissions for drug/device combination products filed pursuant to section 505 of the FD&C Act or subsection (a) or (k) of section 351 of the PHS Act. FDA认为主文件是一个NDA、ANDA、BLA或IND的申报资料，因此在第745A(a)部分设定的要求管理范围内。这些包括了新药主文件（DMF）（21CFR 314.420），新生物药品文件（BPF）（21 CFR 601.51），以及对之前提交的DMF或BPF的所有补充或年报。本指南也适用于根据FD&C第505部分，或PHS法案第351部分（a）或（k）所提交的药物/器械复合产品的申报资料。 A submission that is not in the electronic format(s) described in this guidance document will not be filed or received, unless it has been exempted from the electronic submission requirements (see section III.C) with respect to that submission. 未以本指南中描述的电子格式提交的申报资料将不会被存档和接收，除非该申报资料是可以免于符合电子申报要求的（参见第IIIC部分）。 Under section 745A(a)(3) of the FD&C Act, the electronic submission requirements do not apply to submissions described in section 561 of the FD&C Act. FDA will continue to accept submissions under section 561 in alternative formats. 根据FD&C法案第745A（a）(3)部分，电子提交要求不适用于FD&C法案第561所述的申报资料。FDA会继续根据561部分以其它格式提交的申报。 B. Timetable for Implementation of Electronic Submission Requirements 电子申报要求实施时间表 The requirement to submit electronically for NDAs, ANDAs, BLAs, and master files takes place 24 months after this guidance is published. The requirement for INDs takes place 36 months after this guidance is published. For all of these submission types, you must electronically submit any amendments, supplements, and reports, even if the original submission was submitted to FDA prior to implementation of the electronic submission requirements. 本指南公布后24个月，NDA、ANDA、BLA和主文件电子提交要求生效。IND要求在36个月后生效。对于所有此类申报类型，你必须采用电子方式提交所有增补、补充和报告，即使初始申报资料是在FDA实施电子提交要求之前提交的。 An example of a timetable for the initial implementation of the electronic submission requirement is below. Table 1 summarizes the timetable. 电子申报要求的初始实施时间时间表样例如下。表1总结了该时间表。 On May 15, 2015, FDA publishes the final “Guidance on Providing Regulatory Submissions in Electronic Format -- Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” Submission types NDA, ANDA, BLA and master files must be submitted in eCTD format beginning May 15, 2017. IND submissions must be submitted in eCTD format beginning May 15, 2018. 4 2015年5月15日，FDA公布最终“”指南。申报类型NDA、ANDA、BLA和主文件自2017年5月15日起必须以eCTD格式提交。IND申报资料自2018年5月15日起必须以eCTD格式提交。 Table 1: Example of a Timetable for the Initial Implementation of the Electronic Submission Requirement Submission Type | Final eCTD Guidance Published to FDA Web site (yyyy-mm-dd) | Date Requirement Begins(yyyy-mm-dd) | NDAANDABLAMaster files | 2015-05-15 | 2017-05-15 | Commercial IND | 2015-5-15 | 2018-5-15 |
表1：电子提交要求初始实施时间表样例 申报类型 | 在FDA网站上公布最终eCTD指南（年月日） | 要求开始实施日期（年月日） | NDAANDABLA主文件 | 2015-05-15 | 2017-05-15 | 商业IND | 2015-5-15 | 2018-5-15 |
Additional information regarding submissions pertaining to promotional materials made to the Office of Prescription Drug Promotion in CDER and to the Advertising and Promotional Labeling Branch in CBER will be described in another guidance. Refer to that guidance for the timetable for implementation of those submissions in electronic format. 关于包含促销物料，必须提交给CDER的处方药促销办公室，以及CBER的广告和促销标签分部的提交，在另一份指南中有更多信息。参见那份指南可以找到那些提交使用电子格式的实施时间表。 C. Types of Submissions That Are Exempted From the Electronic Submission Requirement Described in This Guidance Document 免于本指南文件所述电子提交要求的申报类型 Section 745A(a) allows FDA to establish exemptions from the electronic submission requirements. Accordingly, FDA has exempted all submissions regarding noncommercial INDs from the requirements under section 745A(a)[9]. For purposes of this guidance, the term noncommercial products refers to products that are not intended to be distributed commercially and includes investigator-sponsored INDs and expanded access INDs (e.g., emergency use INDs and treatment INDs). 第745A（a）部分允许FDA对电子提交要求进行豁免。相应的，FDA已据此豁免了所有非商业IND的提交，它们可以不必符合这些要求。在本指南中，术语“非商业药品”是指不会进行商业销售的药品，包括临床前申请的IND和扩大许可IND（例如，紧急用途IND和治疗用IND）。 Although these submissions will be exempt, FDA also accepts their submission electronically as described in this guidance document. 尽管这些提交会被豁免，FDA还是接受它们按本指南文件所述进行电子提交。 D. The eCTD Specifications eCTD规范 你必须采用FDA目前支持的eCTD版本来提交电子申报。目前支持的eCTD版本在数据标准目录有指定（上述网址可以找到），并在以下技术规范文件中有进一步描述。 l ICH[10] Electronic Common Technical Document Specification l ICH电子通用技术文件（eCTD）规范 l ICH eCTD Backbone File Specification for Study Tagging Files l ICH研发标识文件电子通用技术文件（eCTD）规范 l FDA eCTD Backbone Files Specification for Module 1 l FDA eCTD模块1框架文件规范 本文件中引用了一些其它的技术规范文件。采用eCTD格式提交所需的完整的技术支持文件（例如，类型表和验证值）请参见eCTD网站。 E. Pre-Submission Considerations 提交前考量 在一个申报的首次提交之前，你必须联系适当的中心以获得一个预先给定的申报编号。关于如何获取预订申报编号，请参见FDA的eCTD网站。 F. Submission Structure: Granularity, Files, and Folders 申报文件结构：大纲层次、文件和文件夹 Document granularity, or the level for which the submission content is broken out into separate files, must be consistent with the FDA guidance for industry M4 Granularity Annex, Granularity Document — Annex to M4: Organization of the CTD, unless otherwise specified in the ICH M2 technical specification eCTD IWG Question and Answer and Specification Change Request Document. 提交文件目录分为单个文件的分层，或层次级别必须与FDA行业指南M4层次附录“分层文件---M4附录：CTD的组织”保持一致，在ICH M2技术规范“eCTD IWG问答和规范变更申请文件”中另有指定者除外。 With a few exceptions, the eCTD specification maps Common Technical Document (CTD) headings to Extensible Markup Language (XML) elements[11]. The specification indicates that each element (heading) is optional and that multiple document references (eCTD leaf elements) can be created under each heading. 除了少数例外，eCTD规范列出了CTD标题中的XML要素。规范指出了每个可选的要素（标题），以及可以在每个标题下创建的多重文件索引（eCTD页要素）。 You must also follow the FDA eCTD technical specification Table of Contents Headings and Hierarchy for the comprehensive listing of headings and hierarchy and a section mapping the headings to their respective regulations. Because this is a comprehensive listing, not all headings are applicable to all submissions or submission types. 你必须遵守FDA的eCTD技术规范“目录标题和层次”中对综合性标题及层次列表的要求，应有一个部分列出标题对应其相应的规定。由于这是一个综合性的清单，并不是所有标题都适用于所有的提交或提交类型。 Files pertaining to each module must be placed in the appropriate folder (e.g., m1 – m5). The terms folder andsubfolder, as used in this guidance, are intended to be synonymous with directory and subdirectory. The main submission, regional administrative folders, and certain subfolders must have specific names. 每个模块中包括的文件必须放置在适当的文件夹中（例如，m1-m5）。本指南中使用的术语“文件夹”和“子文件夹”，是“目录”和“子目录”的同义词。提交资料的主内容，地区行政文件夹，以及特定的子文件夹必须使用特定的名称。 You must use only letters, numbers, hyphens, or underscores in the folder and file names and not blank spaces or special characters. When naming folders and files, the length of the entire path must not exceed 150 characters. Empty folders and files must not be included in the submission. 文件夹和文件命名中，你只能使用字母、数字、连字符，或下划线，不能使用空格或特殊字符。在命名文件夹和文件时，全部路径的长度不应超过150个字符。提交资料中不能有空的文件夹或文件。 All documents in the electronic submission must be placed in a main submission folder and named using a four-digit sequence number (which you must specify) that is unique within the application. The eCTD backbone file for modules 2 to 5 (index.xml) for the submission must be placed in this folder along with the checksum file for the eCTD backbone file (index-md5.txt). Numbering for each subsequent submission to the same application is described in the FDA technical specification eCTD Backbone Files Specification for Module 1 (see section III.D). Sequence numbers are used to differentiate between submissions within the same application and need not correspond to the order in which they are received by FDA. It is not necessary for sequence numbers and IND serial numbers to match for submissions to an IND. 电子申报中的所有文件必须放在一个主申报文件夹中，使用一个四位序列号命名（必须指明），该序列号在同一申报资料中必须是唯一的。申报资料中模块2至5（index.xml）的eCTD大纲文件必须与eCTD大纲文件(index-md5.txt)检查汇总文件一起放在该文件夹中。之后的同一申报提交的文件编号已在FDA技术规范“模块1的eCTD大纲文件规范”（参见第III.D部分）中给出。序列号是用于区别同一申报中不同提交文件，不需要对应FDA接收的顺序。序列编号不需要与IND的系列号相符合。 Subfolders within each module are required to organize files in a submission. These subfolders must be placed in the sequence number folder. Empty subfolders must not be included. The util subfolder is required to organize supporting eCTD technical files in the submission, as described in the ICH M2 technical specification Electronic Common Technical Document Specification (see section III.D). Other specific folder names that are compliant with the eCTD version 3.2.2 format can be found in the same document. 每个模块中的子文件夹必须在一份申报资料中进行组织。这些子文件夹必须放在序列编号的文件夹中。不能包括空的子文件夹。要根据ICH M2技术规范“eCTD规范”（参见第III.D部分）的要求组织UTIL子文件夹来支持申报中的eCTD技术文件。其它符合cCTD版本3.2.2格式的特定文件夹名称可以在相同文件中找到。 G. File Formats and Versions 文件格式和版本 Files within an eCTD submission must adhere to the formats and versions specified in the associated FDA technical specification Specifications for File Format Types Using eCTD Specifications. Portable Document Format (PDF) files submitted must adhere to the FDA technical specification Portable Document Format (PDF) Specifications. 一个eCTD申报中的文件必须服从同一FDA技术规范“使用eCTD规范的文件格式类型要求”中的格式和版本要求。提交的PDF文件必须服从FDA技术规范“PDF规范”。 H. Document Lifecycle 文件生命周期 If a document replaces a document previously submitted with an eCTD backbone file within the same application, you must use the eCTD replace operation to indicate this, rather than submitting the file as new. You must not indicate that files are new if they are in fact replacing files already submitted. If you intend to remove a file, you must use the deleteoperation. For instructions, see the ICH M2 technical specification Electronic Common Technical Document Specification (see section III.D). 如果一份文件取代了之前提交的相同申报资料中的eCTD大纲文件，你必须使用eCTD“替换”操作来进行标识，而不是提交“新的”文件。如果它们是用来替代已提交过的文件，那你不能将该文件标识为“新的”。如果你是要删除一个文件，你必须使用“删除”操作。详细操作，参见ICH M2技术规范“eCTD规范”（参见第III.D部分）。 I. Summary of Clinical Efficacy and Summary of Clinical Safety 临床有效性综述和临床安全性综述 When submitting a Summary of Clinical Efficacy and/or Summary of Clinical Safety, the location of these documents within the eCTD must adhere to the FDA guidance for industry Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document. 在提交临床有效性综述和/或临床安全性综述时，这些文件在cCTD里的位置必须服从FDA行业指南“有效性和安全性综述整合：在CTD文件里的位置”。 J. Datasets and Study Information 数据系列和研发资料 Datasets must only be provided in modules 3, 4, or 5 and not in modules 1 or 2. When providing study information in either module 4 or 5, you must include the Study Tagging File (STF) described in the associated ICH M2 technical specification eCTD Backbone File Specification for Study Tagging Files (see section III.D). Datasets must be referenced in an STF using the appropriate STF file-tag describing the document’s contents. 数据系列必须只在模块3和模块4中提交，而不能在模块1或模块2中提交。在模块4或模块5中提交研究资料时，你必须包括研究标签文件（STF），该STF文件在ICH M2技术标准“研究标签文件的eCTD大纲文件标准”（参见第III.D部分）有规定。数据系列必须在一个STF中使用适当的STF文件标签引用，在其中描述文件内容。 For further information regarding the submission of study data, see FDA guidance for industry Providing Regulatory Submissions in Electronic Format — Standardized Study Data. 关于研究数据提交的更多信息，参见FDA行业指南“电子格式提交法规申报资料---标准化研究数据”。 K. Transmitting Electronic Submissions 电子提交发送 The FDA Electronic Submissions Gateway (ESG)[12] enables the secure submission of regulatory information for review and is our preferred method of transmission. For all submissions that are 10 gigabytes (GB) or smaller, you must use the FDA ESG. FDA电子提交端口（ESG）可以保证所审核的法规信息申报资料的安全，是我们优先的传送方法。所有等于或小于10GB的申报资料，你必须使用FDA ESG。 For submissions that are greater than 10 GB, refer to the FDA technical specification Specification for Transmitting Electronic Submissions using eCTD Specifications. 大于10GB的申报资料，请参考FDA技术规范“使用eCTD规范传送电子申报资料的要求”。 L. FDA Forms FDA表格 电子提交必须只包括FDA可提交文件表（例如，1571或356h）以及电子签名，以使得系统可以自动处理这些提交资料。FDA表格可以在上述网址找到。不接受扫描的FDA表格图像。 M. Restrictions on Submission of Paper Copies 纸质提交限制 When submitting in eCTD format, paper copies of the application, including review copies and desk copies in paper, must not be submitted. The only exception to this is the submission of paper copies of meeting briefing materials, when requested, as described in the FDA guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants. 在采用eCTD格式提交时，申报文件的纸质备份，包括纸质审核备份和桌面备份就不能提交了。对会议总结（要求时）的纸质材料提交的例外情况在FDA行业指南“FDA和申报人之间的正式会议”中有描述。 N. Receipt Date 接收日期 The receipt date for an electronic submission will be determined only after the submission has passed a technical validation check to ensure that it can be opened, processed, and archived. The submitter is responsible for monitoring their receipt pathway to determine whether a submission has been rejected. Additional information on the validation of electronic submissions is available in the FDA technical specification Specifications for eCTD Validation Criteria. 电子提交的接受日期只有在提交资料通过技术验证检查后才能确定。这些检查是为了保证提交资料可以打开、处理和存档。提交者有责任跟踪其接收路径，以确定该提交资料是否被拒。关于电子提交验证信息可以在FDA技术规范“eCTD验证标准规范”中找到。 Additional information on receipt dates for electronic submissions is available in the FDA guidance for industryProviding Regulatory Submissions in Electronic Format — Receipt Dates. 关于电子提交接收日期的更多信息可以在FDA行业指南“以电子格式提交法规申报资料---接收日期”中找到。 Contact Information 联系信息 For questions related to providing electronic submissions according to the recommendations in this guidance, you should contact the Center electronic submission coordinator at esub@fda.hhs.gov for submissions to CDER andesubprep@fda.hhs.gov for submissions to CBER. Specific questions pertaining to the content of applications should be directed to the appropriate review division or office. 与本指南建议的电子提交相关问题，请联络中心电子提交协调员，[url=mailto:%E9%82%AE%E7%AE%B1esub@fad.hhs.gov%EF%BC%88CDER]邮箱esub@fad.hhs.gov（CDER[/url]），[url=mailto:%E6%88%96esubprep@fda.hhs.gov%EF%BC%88CBER]或esubprep@fda.hhs.gov（CBER[/url]）。与申报资料内容有关的问题请直接联络适当的审核中心或办公室。
TECHNICAL SPECIFICATION DOCUMENTS INCORPORATED BY REFERENCE 参考文献结合的技术规范文件 The following are technical specification documents incorporated by reference into this guidance (see section I). Documents are listed in order of first appearance in this guidance. 以下技术规范文件通过索引结合至本指南（参见第I部分）。在此按本指南中出现的顺序列出这些文件。 为了按eCTD 格式提交文件，你所需要提交的技术支持性文件完整清单参见eCTD网页 ICH M2技术规范，电子通用技术文件规范 ICH M2技术规范，eCTD研发标识文件框架文件规范 FDA技术规范：eCTD模块1框架文件规范 FDA行业指南，ICH M4大纲层次附录，大纲层次文件---M4附录：CTD文件结构 ICH M2技术规范，eCTD专家组问答和规范变更申请文件 FDA技术规范，FDA eCTD目录标题和分层 FDA技术规范，采用eCTD 规范的文件格式类型 8. FDA technical specification, FDA Portable Document Format (PDF) Specifications (accessible at FDA技术规范，FDA可移植文件格式（PDF）规范 FDA行业指南，有效性和安全性整合综述：在CTD文件里的位置 FDA技术规范，传送技术，使用eCTD规范的电子申报文件传送规范 FDA技术规范，eCTD验证规范网站，eCTD验证标准 RELATED REFERENCES 相关文献 FDA行业指南，采用电子格式提交法规申报---根据联邦食品药品化妆品法案第745A(a)部分进行的申报 FDA行业指南，采用电子格式提交法规申报---标准化研发数据 FDA行业指南，FDA和申报人之间的正式会议 FDA行业指南，采用电子格式提交法规申报---接收日期
[1] This guidance has been prepared by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research at the Food and Drug Administration. We update guidances periodically. For the most recent version of a guidance, see FDA’s Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
[2] The term human pharmaceutical product, as used in this guidance, includes any product intended for human use that meets the definition of drug and does not also meet the definition of device under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including both drugs approved under the FD&C Act and biological products approved under the Public Health Service Act.
[3] For additional information on how FDA interprets and intends to implement the electronic submission requirements of section 745A(a) of the FD&C Act, please see the guidance for industry Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act.
[4] For instance, to reflect the evolving nature of the technology and the experience of those using this technology, the Electronic Common Technical Document (eCTD) technical specifications are being provided as separate documents that are incorporated by reference into this guidance. These associated specifications will be updated periodically. To make sure you have the most recent version of related technical specifications (CDER and CBER), check the eCTD Web page athttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm153574.htm.
[5] This guidance is not applicable to INDs for devices that are regulated by CBER as biological products under section 351 of the PHS Act and that also require the submission of an IND prior to the submission of a BLA. Although a discussion of which devices CBER regulates as biological products is outside the scope of this guidance, as a general matter, this category of INDs would include investigational devices that are used to screen blood donors for certain transfusion-transmissible diseases and to test human cells, tissues, or cellular or tissue-based products (HCT/Ps) to make a donor-eligibility determination. These submissions are subject to the requirements under section 745A(b). See the final guidance eCopy Program for Medical Device Submissions, which implements the electronic copy provisions of section 745A(b) for medical device submissions to FDA.
[6] This guidance is not applicable to noncommercial INDs.
[7] This guidance is not applicable to those devices that are regulated by CBER as biological products under section 351 of the PHS Act, including those that do not require the submission of an IND prior to the submission of a BLA. Although a discussion of which devices CBER regulates as biological products under section 351 of the PHS Act is outside the scope of this guidance, as a general matter, this category would include those reagents used in determining donor/recipient compatibility in transfusion medicine. These submissions are subject to the requirements under section 745A(b). See the final guidance eCopy Program for Medical Device Submissions.
[8] Specifically, this guidance is not applicable to submissions for blood and blood components, including Source Plasma.
[9] See 745A(a) Implementation Guidance, section III.B.
[10] International Conference on Harmonization.
[11] For example, in Module 3, lower level headings subordinate to 3.2.P.2 (e.g., 3.2.P.2.1, 3.2.P.2.1.1) are not mapped to an XML element. Consequently, leaf element files relating to, for example, 3.2.P.2.1, 3.2.P.2.1.1, must either be submitted as multiple leafs under the parent 3.2.P.2 element (heading) or combined into larger files and submitted at the 3.2.P.2 heading level.
[12] Additional information concerning the FDA ESG is available athttp://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm.
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