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 What is changing in China CMC Regulatory?
It mentions 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. And that the Polysorbate 80 common grade used worldwide is now acceptable in China for biologics, with no more requirements for reformulation or additional justification.
The poster also mentions changes in submissions, e.g., excipients and primary packaging materials now need to be registered on the Chinese Drug Master File platform before use in products.
Importantly, it also summarizes what is not changing in areas such as analytical considerations, e.g., abnormal toxicity testing: the only recognized standard for the absence of toxicity is still done through animal testing on each imported batch. Other areas of filing submissions also remain unchanged, such as the difficult Manufacturing and Testing Protocol which mandates more details than Module 3 and GMP information.
The poster format is an efficient way to communicate a lot of information. 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.