Electronic submission using the Electronic Common Technical Document (eCTD) can involve the use of several resources. These resources will help provide direction in the submission process.
- FDA Guidances
- eCTD Submission Standards Catalog
- Data Standards Catalog
- Technical Conformance Guide
- Validation Specifications
- Fact Sheets
- Additional Resources
Final guidances related to eCTD:
- Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 111 KB)
Published May 2015. This guidance describes how sponsors and applicants must organize the content that they submit to FDA electronically for all submission types under section 745A(a) of the Federal Food, Drug, and Cosmetics (FDC) Act.
- Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Receipt Dates (PDF - 218 KB)
Published February 2014. This guidance explains how FDA will assign receipt dates to regulatory submissions to CDER and CBER for drug products.
- Final Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document (PDF - 98 KB)
Published April 2009. This guidance is intended to clarify for industry where to include the integrated summary of effectiveness (ISE) and the integrated summary of safety (ISS) when submitting applications in the common technical document (CTD) format.
Draft guidances related to eCTD:
- Draft Guidance for Industry: Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs (PDF - 252 KB)
Published April 2015. This draft guidance explains certain aspects of electronic submission of promotional materials in module 1 of the eCTD.
- Draft Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (PDF - 336 KB)
Published December 2017. This guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological drug products regulated by CDER and CBER.
eCTD Submission Standards Catalog
Data Standards Catalog
Electronic submissions must use the version of eCTD currently supported by FDA, which is specified in the FDA Data Standards Catalog on the Study Data Standards Resources page.
Technical Conformance Guide
Provides specifications, recommendations, and general considerations on how to submit eCTD-based electronic submissions to CDER or CBER.
Information required to validate an eCTD submission.
- eCTD Submission Requirements: What You Need to Know (PDF - 224KB)
- FDA Electronic Submissions Gateway (PDF - 208KB)
- Getting Started: Creating an ESG Account (PDF - 210KB)
- New Requirements for Electronic Submissions of DMFs (PDF - 208KB)
- eCTD Submission Types and Sub-Types (PDF - 630 KB)
- Important Notices Archive
A list of important notices related to eCTD submissions.
- FDA Forms
This collection includes forms for applications and submissions, reports and accountability, certifications, and inspections.
- Technical Rejection Criteria for Study Data (PDF - 92KB)
Study Data Standards are required in clinical and nonclinical studies. Technical rejection criteria is being added to the existing eCTD validation criteria.
- Electronic Common Technical Document (eCTD) v4.0
To prepare for the FDA implementation of the eCTD v4.0 standard, FDA is making the documentation available for download and should be used for implementation planning purposes only.
- Technical Conformance Guide for Shared System REMS Drug Master File Submissions
This document provides specifications, recommendations, and general considerations on how to submit
Risk Evaluation and Mitigation Strategy (REMS) submissions to a Type V Drug Master File (DMF) that is being used for a Shared System REMS (SSR).
- REMS 1.16 Subheading Instructions for eCTD M1 v2.3 (DTD 3.3) (PDF - 123KB)
This documents provides information to assist applicants on where to place documents under the eCTD Module 1 REMS 1.16 sub-headings using DTD v3.3 of the us-regional.xml file.
- Structured Product Labeling Resources
The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.
- FDA Adverse Events Reporting System (FAERS) Electronic Submissions
The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA.
This guidance discusses the principles of good meeting management practices (GMMPs) and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings.
- Regulatory Guidance Drug Registration and Listing
Section 510 of the Federal Food, Drug, and Cosmetic Act requires manufacturers, repackers, and relabelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and human biological products to register their establishment(s) and submit a listing of every product in commercial distribution with the FDA.
- Electronic Common Technical Document (eCTD) Course
This course will walk you through the essential steps of submitting electronic submissions to the Center for Drug Evaluation and Research (CDER), and can serve as a resource for questions about the submission process.
- Recent FDA eCTD Presentations
Refer to presentation slides from FDA speaking engagements.
- CDER Small Business Industry Assistance (SBIA) webinars
View archived SBIA webinars.