Chinese regulator catching up on novel drug approval pathways

3 December 2021

Research from industry analyst GlobalData finds that China is ahead of Japan but behind the USA and European Union in terms of review designations.

The report comes several years after China reformed its regulatory system to incorporate various fast-track pathways to catalyze the development of new therapies for unmet medical needs.

Since these processes were introduced in 2015, there have been over 190 drugs awarded either a priority review, breakthrough therapy, or accelerated approval designation.

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