(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)
ICH Releases Draft Update of M4Q Guideline for Public Comment
The International Council for Harmonisation (ICH) has released a draft update of its M4Q(R2) guideline, “The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality”, now open for public comment as of May 2025.
The revised guideline enhances quality-related sections in Modules 2 and 3 of the CTD, covering both APIs and finished products—chemical and biological. It aims to improve regulatory submissions and lifecycle management efficiency.
Key updates include expanded content on quality overview, development strategy, control strategy, lifecycle management, and optional benefit-risk assessment. The structure includes chapters on scope, organization, summaries, body of data, and glossaries.
The full draft, concept paper, and business plan are available on the ICH website under the “Public Consultations” section.
01-07-2025
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