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Regulatory Newsletter Archive

The WuXi Biologics’ Regulatory Affairs team is honored to provide you on a quarterly basis with a summary of what we deem as the relevant (i.e., product development and CMC-related) regulatory updates that are either in draft or final status by agency and by topic. The intent of these updates is to provide the global regulatory agencies’ (e.g., U.S FDA, EMA, NMPA, ICH, HSA, ANVISA, PMDA, MFDS, TGA, Health Canada etc.) updates and new or revised documents during the period stated in the corresponding webpages. We have compiled these updates to support your efforts to stay current in the ever-changing regulatory environment for biological therapeutics and vaccines.  You can use the year filter to the right and scroll down the page to see the various quarterly updates.

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