CDE Rejected 542 Drug Applications in 2021
In 2021, China’s Center for Disease Evaluation (CDE) has rejected 542 drug registration applications. 359 rejected applications were due to failure of submitting supplementary dossiers in time (hereinafter “Exceed Deadline”), accounting for 66.3% of all rejected applications. The overdue cases included applications of 9 Traditional Chinese Medicine (TCM), 349 chemical drugs, and 1 biological product.…