Submission Questions? They Wrote the Book.

U.S. FDA

The following table outlines eCTD-focused guidance documents issued by the U.S. FDA:

FDA eCTD Guidance Documents




Document Issue Date URL
Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Rev 2, June 2008 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072349.pdf
The eCTD Backbone Files Specification for Module 1 1.3, Dec 2006 http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163552.pdf
ICH eCTD Specification 3.2.2, July 2008 http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163556.pdf
Comprehensive Table of Contents Headings and Hierarchy 1.2, July 2005 http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163175.pdf
FDA Implementation of Study Tagging File v2.2 2.6, Aug 2005 No longer posted - FDA web site now points to ICH STF 2.6.1.
Providing Regulatory Submissions in Electronic Format - General Considerations Rev 1, Oct 2003 http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm124751.pdf
Providing Regulatory Submissions in Electronic Format — Receipt Date June 2007 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072385.pdf
Specifications for eCTD Validation Criteria Mar 2008 http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163563.pdf
Portable Document Format Specifications 2.0, Jun 2008 http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163565.pdf
Study Data Specifications 1.6, Jun 2011 http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM199759.pdf
Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document Apr 2009 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM136174.pdf