M4Q(R2); The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; Draft Guidance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

The commenter is seeking clarification on where specific development work regarding drug substance characteristics and impurities will be located in the new M4Q(R2) draft. They also request more concrete information on the content of each subsection compared to the current guidance.

Veeva Systems, a cloud-based software company for the life sciences industry, supports the FDA's proposal to require the ICH M4Q(R2) format for CMC information. They offer specific recommendations regarding lifecycle management of structured data, alignment with existing standards, and the development of global transition plans.

Otsuka Pharmaceutical Development & Commercialization, Inc. expresses support for the draft guidance regarding the Common Technical Document for the registration of pharmaceuticals. They suggest specific improvements, such as clarifying the inclusion of raw materials like processing aids and requesting a transition period for industry compliance.

Insmed Incorporated expresses support for the draft guidance on the Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality.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.

The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) submitted comments regarding the draft guidance for the Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality. They suggest specific clarifications and definitions regarding novel excipients, product intermediates, and development summaries to better align with industry practices and intellectual property protections.

The Association for Accessible Medicines (AAM) supports the modernization of the M4Q(R2) draft guidance but requests a long transition period of at least five years to manage the operational impact on generic and biosimilar manufacturers. They also advocate for the guidance to be applied prospectively rather than retroactively and request further clarification to avoid information duplication within the new framework.

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 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.