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BIO Submits Comments on NMPA Draft Technical Guideline on Clinical Trials of Cellular Immunotherapy Products

November 2, 2020

On August 6, BIO submitted comments on the NMPA Draft Technical Guideline on Clinical Trials of Cellular Immunotherapy Products. In the comments, BIO thanks NMPA for the opportunity to submit comments but argues for a more robust commenting period in line with WTO recommendations in the future. BIO’s preliminary review is generally supportive of the guideline, commending China “for joining the growing number of countries preparing its regulatory system for the proliferation of these innovative therapies.” BIO was also pleased to note the document’s references to relevant ICH guidelines and applauded NMPA’s engagement in ICH, including on the Management Committee. BIO looks forward to the NMPA’s final guidance on the topic.

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BIO Comments -CDE Cell Therapy Clinical Trial
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