BioPhorum Feedback to the International Council for Harmonisation (ICH) Guideline on the Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality (M4Q(R2))

This publication presents consolidated industry feedback from BioPhorum Regulatory CMC members on the draft ICH M4Q(R2) guideline for the Common Technical Document (CTD) Quality module. Developed through structured reviews, workshops, surveys and line‑by‑line analysis, the paper reflects a consensus view from regulatory CMC experts across the biopharmaceutical industry. Industry contributors strongly support the direction of M4Q(R2), recognizing it as a significant evolution in how quality information is structured, summarized and maintained throughout the product lifecycle. Key enhancements include improved clarity between Modules 2.3 and 3, strengthened lifecycle management alignment with ICH Q12 and increased readiness for digitalization and structured data. Despite this overall support, the industry highlights several areas requiring further clarification to ensure consistent global adoption. These include expectations for transition timelines, practical examples of information placement, cross‑referencing practices, treatment of region-specific requirements and clearer guidance on digital implementation. The document also presents detailed line‑by‑line comments submitted via the EMA, indicating where terminology, examples or structural refinements would further improve usability and harmonization. The report concludes with implementation considerations, noting the need for updated SOPs, templates and training, and emphasizes the importance of alignment with partners and the use of mock submissions to support adoption. BioPhorum and its members remain committed to collaborating with ICH and regulators to ensure successful global implementation of M4Q(R2)