China’s NMPA Introduces New Revised Regulation for Drug Approval by Foreign Companies

Overview: China’s National Medical Product Agency (NMPA) proposes a revision on pharmaceutical approval. The revision focuses mainly on generic drugs and how to increase the safety requirements for clinical trials, limit false clinical data and encourage drug approval process. China additionally released the second batch of urgently needed drugs from foreign manufacturers.  New Drug Review …

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China’s NMPA issues Guideline for changes of Raw Material in Passive Medical Device Products.( No. 33 2020)

China’s NMPA issued a guidance (No 33. 2020) on May 19, 2020 to provide a guideline and systematic approach for risk analysis of raw material changes in passive medical device products .

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