Af­ter a makeover and hir­ing spree, Chi­na's drug agency is romp­ing and stomp­ing on new re­views and ap­provals

When it comes to the re­forms at Chi­na’s drug agency, now un­der­go­ing a name change, pol­i­cy changes and even their out­comes are rel­a­tive­ly easy to spot, but num­bers are hard­er to come by. In a year­ly re­port re­leased last week, though, the agency of­fered some rare sta­tis­tics to track its progress over the past few years and il­lu­mi­nate R&D pri­or­i­ties in the coun­try.

The re­port high­lights some big trends that have ma­jor im­pli­ca­tions for all com­pa­nies look­ing to land a mar­ket­ing OK and roll out new drugs in the boom­ing Asian mar­ket. Af­ter beef­ing up the num­ber of reg­u­la­tors on staff, Chi­na’s FDA slashed re­view times to a frac­tion of what they had been. There’s been a con­tin­ued de­cline in the over­all num­ber of back­logged ap­pli­ca­tion, thanks to in­creased speed at the agency. In drug INDs alone, the Cen­ter for Drug Eval­u­a­tion han­dled 542 ap­pli­ca­tions and ap­proved 481 of them — among those, 399 cas­es (shared by 170 drugs) were for nov­el drugs.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

Life Sciences Senior Associate

General Catalyst

San Francisco, CA, USA