M4Q(R2); The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; Draft Guidance

The commenter, a pharmaceutical quality-control and analytical-development professional, supports the adoption of the ICH M4Q(R2) guideline as a step toward digitalization and clearer lifecycle management. They propose specific modifications to the dossier structure to explicitly define "critical sample-preparation parameters" and to provide a designated location for documenting AI-assisted or algorithmic decision-support tools.

Insmed Incorporated expresses support for the draft guidance on the Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality. The company proposes several specific refinements and additions to the guidance to improve consistency, clarity, and reduce redundant post-approval filing burdens.

Perrigo Company is seeking technical clarifications regarding specific sections of the draft guidance on the Common Technical Document for the Registration of Pharmaceuticals for Human Use.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.

The Parenteral Drug Association (PDA), a non-profit international professional association, submitted detailed feedback on the M4Q(R2) Draft Guidance. They propose specific technical additions and clarifications regarding nitrosamine risk assessments, AI/ML technologies, primary packaging labeling, and requirements for biologics and combination products to ensure global regulatory alignment.

The Pharmaceutical Research and Manufacturers of America (PhRMA) supports the FDA and ICH's efforts to revise the M4Q(R2) guidance to enhance clarity, reduce duplication, and support global harmonization of pharmaceutical submissions. They provide specific recommendations to improve the structure of the Common Technical Document (CTD), particularly regarding Core Quality Information (CQI), lifecycle management, and the integration of medical device information.

Jitendra Pund suggests specific improvements to the guidance on documenting analytical procedures. The commenter recommends clearly identifying non-compendial procedures, referencing modified compendial procedures, and including an overview table to enhance transparency and consistency.