blogs

Drug Master File (DMF) in China

Since January 1, 2018, CFDA has not been accepting Active Pharmaceutical Ingredients (APIs), Pharmaceutical Excipients and Pharmaceutical Packaging Materials registration application independently. The Active Pharmaceutical Ingredients (APIs), Pharmaceutical Excipients and Pharmaceutical Packaging Materials are now reviewed/approved as part of a drug product application. Before called CFDA, now the National Medical Products Administration (NMPA) had a …

Drug Master File (DMF) in China Read More

Global Regulatory Partners

New Program for the Review of Innovative Medical Devices in China

The Chinese National Medical Products Administration (NMPA) has published revised requirements for its innovative medical device review program that will take effect December 1, 2018. The new NMPA policy, Order 83 [2018] includes three major changes: Applications for Innovative Devices must be submitted to NMPA within five years of patent publications; Application review timeframes will …

New Program for the Review of Innovative Medical Devices in China Read More

Scroll to Top