eCTD webpages

• Electronic Common Technical Document
  Go to eCTD webpage

• Published Guidance and Specifications documents
  Go to eCTD Guidance and Specifications webpage 

•  Table of Contents Headings and Hierarchy
  Go to Table of Contents Headings and Hierarchy webpage
  
  
• Setting up an Electronic Submissions Gateway Account
  Go to Setting up ESG Web Trader
  Go to FDA Electronic Submissions Gateway (ESG) Webinar - August 16, 2011
  
  
• Submitting an eCTD Sample
  Sample Submission Process
  Recommended contents of the sample submission
  
  
• Requesting a Pre-Assigned Application number
  Go to pre-assigned application webpage
  
  
• Requesting eCTD waivers
  Go to waiver webpage
  
  
• Submitting via physical media (CD/DVD)
  Go to Specifications for Transmitting Electronic Submissions using eCTD Specifications

Guidance Documents 

• Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Applications and Related Submissions Using the eCTD Specifications (PDF - 132KB) (June 2008)
• Final Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location within the Common Technical Document (PDF - 98KB) (April 2009)
• Clarification for question #10 of "ICH M4: The CTD -- Efficacy Q&As" on submitting integrated summaries of safety and effectiveness (ISS/ISE) in the eCTD format(9/12/2006)

eCTD Specifications

• FDA eCTD Table of Contents Headings and Hierarchy (PDF - 73KB) (updated 7/7/2005)
• eCTD Backbone Files Specification for Module 1 (PDF - 102KB) (updated 12/13/2006)
• eCTD Backbone File Specification for Modules 2 through 5 3.2.2 (PDF - 726KB) (updated 7/16/2008)
• The eCTD Backbone File Specification for Study Tagging Files 2.6.1 (PDF - 149KB) (6/3/2008)
• Study Data Specifications (PDF - 199KB) (updated 4/1/2010)
• eCTD Validation Specifications (12/10/2010)
• Portable Document Format Specifications (PDF - 57KB) (6/4/2008)
• Transmission Specifications (PDF - 55KB) (updated 8/27/2009)

General Information

• Drug Master Files:
  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122886.htm
  
• Regulatory Submission in Electronic Format - New Drug Application Guidance:
  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163187.pdf
• CDER study data specification:
  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163561.pdf
• Electronic Submissions Gateway:
  http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm114831.htm
• Electronic Submissions Gateway FAQs
  http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm114807.htm
• Electronic Submissions Public Docket
  http://www.regulations.gov/#!docketDetail;D=FDA-1992-S-0039
• ANDA Checklist (for completeness and acceptability of application)
  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/
  ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM151259.pdf
• Recent electronic submissions presentations
  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm229642.htm
• PDF Specifications:
  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163565.pdf
• Guidance for Industry: Providing Regulatory Submissions in Electronic Format -Human Pharmaceutical Product Applications and Related Submissions using the eCTD Specifications
  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072349.pdf
• Specifications for eCTD Validation Criteria
  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm163181.htm