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China's State Council Endorses CFDA's New Foreign Clinical Trial Data Policies

publication date: Oct 9, 2017

Over the weekend, China's State Council issued a broad directive aimed at speeding up China's drug/device approval process, including using foreign trial data for approvals. The directive is a big boost for foreign pharmas that want to bring their drugs to China. In May, the CFDA released Draft Circulars (Numbers 52-55) that outlined the same changes, which were opened to a 30-day comment period. Although this is not the first time these changes have been made public, the official State Council statement means the proposals have been accepted and will be implemented. More details....

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