eCTD: Electronic Common Technical Document
(go back to FDA regulatory documentation page)
eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA's Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER).
Clinical module sections
Module 1
- M1.14.4.1 Investigator’s Brochure (for multi-site trials)
- M1.2 General Investigational Plan
Module 2
- M2.5 Clinical Overview
- M2.7 Clinical Summary
- ~~M2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods
- ~~M2.7.2 Summary of Clinical Pharmacology studies
- ~~M2.7.3 Summary of Clinical Efficacy [indication]
- ~~M2.7.4 Summary of Clinical Safety
- ~~M2.7.5 References
- ~~M2.7.6 Synopses of individual studies
Module 5
- Clinical protocol
- Informed consent form
- CSRs
CMC module sections
Module 2
- M2.3 Quality overall summary
Module 3
- 3.2.S Drug substance
- ~~3.2.S.1 General information
- ~~3.2.S.1.1 Nomenclature
- ~~3.2.S.1.2 Structure
- ~~3.2.S.1.3 General properties
- ~~3.2.S.2 Manufacture
- ~~3.2.S.2.1 Manufacturer(s)
- ~~3.2.S.2.2 Description of Manufacturing Process and Process Controls
- ~~3.2.S.2.3 Control of Materials
- ~~3.2.S.2.4 Controls of Critical Steps and Intermediates
- ~~3.2.S.2.5 Process Validation and/or Evaluation
- ~~3.2.S.2.6 Manufacturing Process Development
- ~~3.2.S.3 Characterization
- ~~3.2.S.3.1 Elucidation of Structure and other Characteristics
- ~~3.2.S.3.2 Impurities
- ~~3.2.S.4 Control of drug substance
- ~~3.2.S.4.1 Specification
- ~~3.2.S.4.2 Analytical Procedures
- ~~3.2.S.4.3 Validation of Analytical Procedures
- ~~3.2.S.4.4 Batch Analyses
- ~~3.2.S.4.5 Justification of Specification
- ~~3.2.S.5 Reference standards or materials
- ~~3.2.S.6 Container closure systems
- ~~3.2.S.7 Stability
- ~~3.2.S.7.1 Stability Summary and Conclusions
- ~~3.2.S.7.2 Post Approval Stability Protocol and Stability Commitment
- ~~3.2.S.7.3 Stability Data
- 3.2.P Drug product [name, dosage form, manufacturer]
- ~~3.2.P.1 Description and composition of the drug product
- ~~3.2.P.2 Pharmaceutical development
- ~~3.2.P.3 Manufacture
- ~~3.2.P.3.1 Manufacturer(s)
- ~~3.2.P.3.2 Batch Formula
- ~~3.2.P.3.3 Description of Manufacturing Process and Process Controls
- ~~3.2.P.3.4 Controls of Critical Steps and Intermediates
- ~~3.2.P.3.5 Process Validation and/or Evaluation
- ~~3.2.P.4 Control of excipients [name]
- ~~3.2.P.4.1 Specification(s)
- ~~3.2.P.4.2 Analytical Procedures
- ~~3.2.P.4.3 Validation of Analytical Procedures
- ~~3.2.P.4.4 Justification of Specifications
- ~~3.2.P.4.5 Excipients of Human or Animal Origin
- ~~3.2.P.4.6 Novel Excipients
- ~~3.2.P.5 Control of drug product
- ~~3.2.P.5.1 Specification(s)
- ~~3.2.P.5.2 Analytical Procedures
- ~~3.2.P.5.3 Validation of Analytical Procedures
- ~~3.2.P.5.4 Batch Analyses
- ~~3.2.P.5.5 Characterization of Impurities
- ~~3.2.P.5.6 Justification of Specification(s)
- ~~3.2.P.6 Reference standards or materials
- ~~3.2.P.7 Container closure system
- ~~3.2.P.8 Stability
- ~~3.2.P.8.1 Stability Summary and Conclusion
- ~~3.2.P.8.2 Postapproval Stability Protocol and Stability Commitment
- ~~3.2.P.8.3 Stability Data
- 3.2.A Appendices
- ~~3.2.A.1 Facilities and Equipment
- ~~3.2.A.2 Adventitious agents safety evaluation
- ~~3.2.A.3 Novel excipients
- 3.2.R Regional information
Nonclinical module sections
Module 2
- 2.4 Nonclinical overview
- 2.6 Nonclinical written and tabulated summaries
- ~~2.6.1 Introduction
- ~~2.6.2 Pharmacology written summary
- ~~2.6.3 Pharmacology tabulated summary
- ~~2.6.4 Pharmacokinetic written summary
- ~~2.6.5 Pharmacokinetic tabulated summary
- ~~2.6.6 Toxicology written summary
- ~~2.6.7 Toxicology tabulated summary
Module 4
- 4.2.1 Pharmacology
- 4.2.2 Pharmacokinetics
- 4.2.3 Toxicology
- Cover reports of non-clinical studies
Administrative module sections
