M4Q(R2) — The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality (FDA draft guidance)

21st January 2026

M4Q(R2) — The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality (FDA draft guidance)

Summary: The M4Q(R2) guidance (draft, January 2026) updates the quality section of the Common Technical Document (CTD) — the internationally harmonised structure for drug registration dossiers — to improve how quality data is organised and presented for FDA review. It reflects work under the International Council for Harmonisation (ICH) and aims to:

• Provide a modernised, globally harmonised framework to organise quality information in Module 2.3 (Quality Overall Summary) and Module 3 (Quality) of the CTD, supporting more efficient regulatory assessment.

• Facilitate digitalisation, structured data use and knowledge management, which can help reduce duplication and enable smoother reviews.

• Align quality dossier expectations with evolving regulatory and science-based approaches, including lifecycle management and emerging manufacturing technologies.

This draft guidance is non-binding and is open for public comment; stakeholders can submit feedback via the specified docket.

Link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m4qr2-common-technical-document-registration-pharmaceuticals-human-use-quality

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