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China Accepts Overseas Clinical Trial Data to Expedite Drugs Registration in China

China Insight - Life Sciences

On 6 July 2018, the China Food and Drug Administration (“CFDA”) issued the Technical Guiding Principles for the Acceptance of the Overseas Clinical Trial Data of Drugs (“Guiding Principles”) effective as of 6 July 2018 in order to further expedite drugs registration in China. The Guiding Principles apply to overseas clinical data to be submitted by drug registration applicants for the registration of new drugs and/or generic drugs in China. The Guiding Principles clearly list the basic principles and requirements on the acceptance of overseas clinical trial data, and distinguish different levels of acceptance based on the quality of the data itself and different circumstances.To read the details, please click "Read more" below.

Source
China Accepts Overseas Clinical Trial Data to Expedite Drugs...
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Authors

Nicolas Zhu
Nicolas Zhu
Partner
Shanghai
Picture of Allie Huang
Allie Huang, LL.M.
Associate
Shanghai