M4Q(R2); The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; Draft Guidance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- M4Q(R2); The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; Draft Guidance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
Overview
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| Organization | Transition period |
|---|
3 organization-typed comments could not be identified.
Explorer
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- Mar 23, 2026Comment from Veeva SystemsSupportBusiness📎 Attachment
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.
Read comment → - Mar 23, 2026Comment from Otsuka Pharmaceutical Development & Commercialization, Inc.SupportBusiness📎 Attachment
Otsuka Pharmaceutical Development & Commercialization, Inc. expresses support for the draft guidance regarding the Common Technical Document for the registration of pharmaceuticals.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.
Read comment → - Mar 23, 2026Comment from Association for Accessible MedicinesSupportAdvocacy📎 Attachment
The Association for Accessible Medicines (AAM) supports the modernization of the M4Q(R2) draft guidance but requests a long transition period of at least five years to manage the operational impact on generic and biosimilar manufacturers.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.
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