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FDA M4 Guidance for Industry · October 2017
CTD filing structure
Five modules. Module 1 is regional; Modules 2 to 5 are intended to be common for all regions.
- Module 1 Administrative Information and Prescribing Information Regional
- Module 2 Common Technical Document Summaries
- Module 3 Quality
- Module 4 Nonclinical Study Reports
- Module 5 Clinical Study Reports
FDA-issued guidance is shown with a qualified FDA-site rights basis. ICH material has separate copyright and public-licence terms.
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- Check the primary source against the intended use.Awaiting a person
- Record any source limitation before relying on it.Awaiting a person
- Ask a person to make the review decision.Awaiting a person
Source details and rights Open
- M4: Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use: Guidance for Industry
Source date October 2017 Retrieved 16 October 2026
FDA-site content is generally public domain unless otherwise noted. The guidance records an ICH process; do not generalise FDA treatment to ICH material.
Rights / licence basis - Electronic Common Technical Document (eCTD)
Source date Page date not stated Retrieved 16 October 2026
FDA says its website content is public domain unless otherwise noted. Check separately credited third-party material; no FDA endorsement is implied.
Rights / licence basis - ICH Legal Mentions
Source date Page date not stated Retrieved 16 October 2026
ICH says its material is copyright-protected and reusable under its public licence with acknowledgement. Third-party content can require separate permission.
Rights / licence basis