CMC Regulatory

Viewing related articles

What’s changing in the Chinese CMC regulatory environment? 

China is a commercial market with enormous potential for the biopharmaceutical industry but is transitioning from a national regulatory environment to one that is harmonized with the global industry, albeit with some local specifics and complexities. BioPhorum’s Post-Approval Strategy Team has been navigating this new Chinese regulatory environment through its many recent changes. To capture its learnings, the team has produced a poster titled...

read more

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.

read more

CMC Regulatory: Clinically relevant specifications: Case study and summary of discussion at BioPhorum Development Group meeting

The FDA’s positions is that “Clinically relevant specifications can be defined as a set of criteria and acceptance ranges to which drug products should conform in order to deliver the therapeutic benefit indicated in the label.”  and that “Clinically relevant specifications increase flexibility within the pharmaceutical manufacturing sector while maintaining quality by establishing acceptance criteria based on clinical relevance, instead of process capability or manufacturing process control.”  The professionals in the BioPhorum CMC Regulatory team are aligned on the concept, but still have practical questions about what is expected.  To address this they considered a case study concerning an mAb-X product and then survey the experience and discussed the positions of twenty four biopharma companies.  This ‘Members Only’ document captures the details of the case study and points of discussion between the companies. No views are attributable to any individual company.

read more