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In May 2025, the International Council for Harmonisation (ICH) released the draft M4Q(R2) guideline, reshaping the regulatory landscape for pharmaceutical quality documentation. This update to the Common Technical Document (CTD) introduces a data-centric, lifecycle-oriented framework for Modules 2 and 3—enhancing clarity, digital readiness, and harmonization across major regulatory jurisdictions including the US (FDA), EU (EMA), Japan (PMDA), Canada (Health Canada), China (NMPA), Brazil (ANVISA), and more.
The M4Q(R2) broadens the scope beyond initial marketing authorization to support post-approval change management and incorporates modern manufacturing technologies like continuous manufacturing and AI/ML tools. For regulatory professionals in North America, Europe, Asia, and LATAM, the guideline signals a strategic pivot toward digital submissions, Quality by Design (QbD), and structured data management across the product lifecycle.
Explore how your region’s pharmaceutical dossier strategy must evolve to meet the ICH M4Q(R2) expectations—and how early adaptation can ensure compliance, reduce approval delays, and future-proof your regulatory operations.
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