Portable Document Format Specification v4.1— 文件格式规范:本指南详细介绍了向美国FDA提交的eCTD中有关PDF文件的相关要求,包括版本、安全设置、字体、页面方向、大小、页边距等细节上的要求。 The comprehensive Table of Contents Headings and Hierarchy: 本指南是一份完
Portable Document Format Specification v4.1— 文件格式规范:本指南详细介绍了向美国FDA提交的eCTD中有关PDF文件的相关要求,包括版本、安全设置、字体、页面方向、大小、页边距等细节上的要求。 The comprehensive Table of Contents Headings and Hierarchy: 本指南是一份完整全面的内容标题和层级表。直观的列出了模块1...
ANDA申请人和持有人应根据FDA的eCTD网页上的“内容标题和层次结构总表(ComprehensiveTable of Contents Headings and Hierarchy)”,在适当的模块和章节中提交各自的说明书文件[10]。 这类提交资料应包括:FDA 356h表格;申请信;申请信中专利和排他性说明(...
ANDA 申请人和持有人应根据 FDA 的 eCTD 网页上的" 内容标题和层次结构总表(Comprehensive Table of Contents Headings and Hierarchy)",在适当的模块和章节中提交各自的说 明书文件[10]. 这类提交资料应包括:FDA 356h 表格;申请信; 申请信中专利和排他性说明(如果需要);修订的说 明书 ;按照 21 CFR 314.94...
REVISIONS October 2015 1.0 Initial Version Updated/Clarified following sections: Section 2.3 (Transitioning to eCTD Format and Resubmission of Non- eCTD Documents), and subsections 2.3.1, 2.3.2, 2.3.3, 2.3.4 Section 2.4 (eCTD Leaf Titles) Section 2.6 (Presubmissions) Section 2.7 (Rolling ...
While a cover letter is not required content for an ANDA, the cover letter is a 36 part of the electronic common technical document (eCTD) hierarchy and is included in Module 1 37 of an ANDA submission.4 38 39 The cover letter provides an overview of the submission and helps FDA ensure...
and sub-headings, including detailed definition under m1.15 Promotional material. These additions are too numerous to mention but are summarized in Appendix 2 of the comprehensive Table of Contents. (The FDA has emphasized that promotional materials are still not accepted in eCTD format at this ...
ANDA申请人和持有人应根据FDA的eCTD网页上的“内容标题和层次结构总表(ComprehensiveTable of Contents Headings and Hierarchy)”,在适当的模块和章节中提交各自的说明书文件 [10]。 这类提交资料应包括:FDA 356h表格;申请信;申请信中专利和排他性说明(如果需要);修订的说明书;按照21 CFR 314.94(A)(8)(iv)所...
13 Applicants may address the deficiencies identified by FDA by submitting an amendment to their application.14 This guidance does not include a comprehensive list of all of the deficiencies identified during ANDA assessment. In addition, it is each applicant’s responsibility to submit a high-...
申报资料的内容要分解成单独文件的级别应该与ICH 行业指南M4 《人用药注册通用技术文 件组织》(2017 年10 月)保持一致,在ICH 行业指南M2 《eCTD 规范问答和变更申请》 (2005 年3 月)中另有说明者除外。 The FDA technical specification The Comprehensive Table of Contents Headings and Hierarchy should be ...