Amended Chinese drug registration regulation aimed at coping with pandemics

14 April 2020

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China recently issued the amended version of drug registration regulation, effective on July 1, reports The Pharma Letter’s local correspondent Wang Fangqing.

This is the first time China has made changes in the regulation after joining the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 2017. According to China's National Medical Products Administration (NMPA), the new version aims to largely improve drugs’ efficacy, safety and accessibility in China.

Compared with the last version, introduced in 2007, major changes include clinical study management, generics encouragement and expedited approval process.

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