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 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.
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