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Chinese Regulator Pushes Limits Of Tightening Conditional Approval Program

 
• By Dexter Jie Yan

A new potential policy shift in China seeks to address abuse of a regulatory shortcut by blocking fast-followers’ applications for related clinical trials.

China's Center for Drug Evaluation explains how it handles applications for conditional approval in complex circumstances.
China's further tightening for the domestic conditional approval program has expanded to the related clinical trials. • Source: Shutterstock

China’s top drug regulator, the National Medical Products Administration (NMPA), is tightening up its conditional approval system - the equivalent of the US Food and Drug Administration’s accelerated approval program - after a more than three-year trial period, as it aims to prevent the pathway from being abused by certain applicants.

On 25 August, the NMPA published proposed amendments to the Pilot Procedure for Review and Approval of New Drug Applications for Conditional Approval, which first took effect in July 2020

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