China’s CDE Explains Major Issues Around Conditional Approval Scheme

China's conditional approval system, which is an accelerated pathway, is being increasingly used by pharma firms, but some thorny issues remain such as the impact on full approvals, the scheme’s relation to priority reviews and currently available therapies and deadlines for confirmatory studies. Staff from the country's Center for Drug Evaluation discussed various topics around the system in a recent article.

China's Center for Drug Evaluation explains how it handles applications for conditional approval in complex circumstances. — China's Center for Drug Evaluation explains how it handles applications for conditional approvals in complex circumstances. • Source: Shutterstock

China’s Center for Drug Evaluation (CDE) has expounded its views on four major issues that have arisen from assessing novel antitumor drug candidates under the country's conditional approval scheme, the equivalent of the US Food and Drug Administration’s accelerated approval program.

China’s Pilot Procedure for Review and Approval of New Drug Application for Conditional Approval, effective since 1 July 2020, stipulates...