M4Q(R2); The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; Draft Guidance
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- Title
- M4Q(R2); The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; Draft Guidance
- Posted
- Jan 21, 2026
- Comment period
- Jan 21, 2026 – Mar 24, 2026
- Topics
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- Mar 25, 2026Comment from Perrigo CompanyOtherBusiness
Perrigo Company is seeking clarification on several specific technical requirements within the draft guidance for the Common Technical Document. They are requesting more precise language regarding Drug Master File references, reference standard information for method validation, and definitions for "reference country" and "if applicable" clauses.
Read comment → - Mar 23, 2026Comment from Perrigo CompanyOtherBusiness📎 Attachment
Perrigo Company is seeking technical clarifications regarding specific sections of the draft guidance on the Common Technical Document for the Registration of Pharmaceuticals for Human Use. They request more precise language regarding Drug Master File references, reference standard requirements, "if applicable" qualifiers for certain justifications, and the definition of "reference country" in reliance procedures.
Read comment → - Mar 19, 2026Comment from Lotus Pharmaceutical Co., Ltd.SupportIndividual📎 Attachment
The commenter is seeking clarification on specific technical requirements within the draft guidance, particularly regarding drug substance information in DMFs and the handling of reference standards. They propose specific language to ensure that specifications for in-house reference materials are only provided where relevant to product quality.
Read comment → - Feb 18, 2026Comment from Sartorius CorporationSupportBusiness📎 Attachment
Sartorius, a manufacturer of tools and materials for drug and biological product manufacturing, provides specific technical feedback on the draft M4Q (R2) guidance. They request clarifications on implementation timelines, the handling of legacy products, and how the new structure supports cross-referencing independent master files for raw materials and intermediates.
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