FDA Draft Guidance: Common Technical Document for Quality

Detected February 6th, 2026

Summary

The FDA has released draft guidance on the Common Technical Document (CTD) for the quality section of pharmaceutical registration applications. This guidance, developed under the International Council for Harmonisation (ICH), aims to harmonize the organization and presentation of quality data for human use pharmaceuticals. Comments on the draft are due by March 23, 2026.

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What changed

The FDA is seeking public comment on draft guidance titled "M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality." This guidance, prepared under the International Council for Harmonisation (ICH), proposes an updated framework for organizing and presenting quality data in registration applications for human use pharmaceuticals. The revisions aim to improve efficiency, facilitate digitalization, and accommodate emerging technologies.

This is a draft guidance, and the FDA is accepting comments until March 23, 2026. Regulated entities, particularly drug and pharmaceutical companies, should review the proposed changes to the CTD quality section. Submitting comments by the deadline is crucial for the FDA to consider feedback before finalizing the guidance. While non-binding, adherence to harmonized standards is generally expected for efficient global registration processes.

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Submit Comments by

03/23/2026

Submit Comments Online Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2025-D-2275

Docket Number: FDA-2025-D-2275 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is intended to establish a globally harmonized framework to organizing and presenting quality data included in registration applications for medicinal products for human use. The draft guidance updates the quality section of the common technical document (CTD) to further improve registration and life cycle management efficiency, facilitate digitalization and knowledge management, and support provisions for emerging technologies.