ICH M4Q(R2): An Update from ICH and CAPRA
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) plays a key role in global pharmaceutical regulatory alignment. The ICH M4Q(R2) guideline, a revision of the M4Q(1) (2002) guideline, aims to improve the efficiency of pharmaceutical submissions and lifecycle management.
M4Q(R2) includes a restructuring of Module 2 and Module 3 with the goal of aligning the concepts with the ICH quality guidelines, facilitating efficient regulatory assessments and increasing the focus on pharmaceutical development and control strategy. The scope is also expanded to all pharmaceutical and biologic products. The revision promotes risk-based approaches to product quality, better management of pharmaceutical development, and enhanced use of digital tools, supporting innovations in data management and submission processes. This convergence aims to accelerate patient access to safe, effective medicines.
Intrinsik attended the recent CAPRA Biologics & Biosimilar Symposium, which included an update from ICH regarding the content and progress of the ICH Q4(2) revision. In the revised CTD structure, Module 2 will serve as the bases for the regulatory assessment of the drug product, with a focus on the control strategy, the core quality information, the scientific and risk-based rationales behind the drug’s development process and life-cycle management. Module 3 will complement Module 2 by providing more granular details about the pharmaceutical product, such as supporting data and detailed reports.
The implementation of M4Q(R2) is planned in several key phases and the recent update from ICH described the key future milestones. Sign-off is expected at the ICH meeting in May 2025, followed by endorsements by Members of the Assembly in June 2025 and release for public consultation. Final sign-off and adoption is expected in June 2027.
Intrinsik will keep providing updates as the ICH Q4(2) guidance is rolled out, including its eventual implementation at Health Canada and the U.S. Food & Drug Administration. Intrinsik’s scientific experts specialize in authoring and review of chemistry, manufacturing, and controls (CMC) information and preparing regulatory documents for all development phases. For more details on upcoming changes that may affect the quality sections of your application, or if you have any general inquiries about how Intrinsik can support your company, please reach out to us at .