Mock example developed to illustrate quality modules of ICH M4Q (R2) Common Technical Document

18th February 2026

Summary: The ICH M4Q (R2) Expert Working Group has created a mock illustrative example — named Sakura Bloom R2 — to show how the proposed revised Modules 2.3 and 3 of the Common Technical Document (CTD) for quality information might be structured and presented in practice. It’s based on a fictitious small-molecule product and is intended to support industry and regulators in interpreting the draft M4Q (R2) guideline, which is currently out for public consultation. The mock example does not represent an actual regulatory submission and may not align with all ICH quality requirements or regional specifics; rather, it serves as an educational demonstration of the guideline’s concepts to improve clarity around dossier format and content expectations.

Link: https://www.ich.org/news/mock-example-developed-illustrate-quality-modules-ich-m4qr2-common-technical-document

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