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What is changing in China CMC regulatory?

BioPhorum’s Post-Approval Strategy Team has produced a poster titled What is changing in China CMC Regulatory? It refers to a wide range of changes in areas such as pharmacopeia, e.g., more convergent monographs in CHP 2020 than any other version of the Chinese Pharmacopeia. It also talks about changes in submissions, including excipients and primary packaging materials need to be registered on the Chinese Drug Master File platform before use in products. It can be used by BioPhorum member organizations, displayed in a CMC regulatory office, used at CMC meetings, and shared with colleagues outside the regulatory function.

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Industry feedback on ICH Q12: implementation considerations for FDA-regulated products

The aim of ICH Q12 is clearly stated as a framework to facilitate the management of post-approval CMC changes. This document in the industry response to an agency consultation on draft guidance on ICH Q12. The biopharmaceutical industry through these comments commends the agency on leading the way to the implementation of ICH Q12. The BioPhorum comments are heavily influenced by the principle of simplification, which is why our views sometimes differ from the draft guideline.

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Trends in outsourcing of CMC development services for biologics

The interplay, engagement and interactions between Sponsor and C(D)MO are frequently considered, presented and discussed at the BioPhorum Development Group, a gathering of more than 20 global biopharmaceutical companies, representing both Sponsor and C(D)MO organizations, with a focus on chemistry, manufacturing and controls (CMC)-related clinical biopharmaceutical development, testing and manufacture. This self-survey was aimed at understanding outsourcing approaches and governance and focused on analytical development and testing, process development and manufacturing, project management and governance and quality system and regulatory support. From the aggregate survey responses in each area, key trends were identified, providing insights to potential best practices

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