FDA的eCTD技术符合性指南 2019.12 英文.pdfVIP

eCTD TECHNICAL CONFORMANCE GUIDE Technical Specifications Document This Document is incorporated by reference into the following Guidance Document(s): Guidance for Industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications For questions regarding this technical specifications document, contact CDER at esub@ or CBER at esubprep@ 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) December 2019 eCTD TECHNICAL CONFORMANCE GUIDE December 2019 REVISION HISTORY DATE VERSION SUMMARY OF 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 Submission) Section 3.1.2 (Cover Letter and Reviewer’s Guide) Section 3.1.7 (Information Amendments) Section 3.1.8 (Letters of Authoriza