China FDA plowed through trial and new drug applications in 2015, commissioner says

CFDA Commissioner Bi Jingquan

China FDA went through 9,394 clinical trial and new drug applications in 2015, Commissioner Bi Jingquan said in a press release, which was almost double the previous year's tally, taking a chunk out of a backlog estimated earlier last year of around 20,000 applications. A self-audit push started last year saw 1,151 drug filings pulled with the majority coming from smaller domestic firms. In a broad review of the past year, known as a work report, and a look ahead, Bi said bio-equivalency evaluations will be stepped up for generic drugs and approvals will be bolstered by added manpower and facilities, while medical devices will be newly classified. The CFDA "will continue to push forward the reform of the drug review and approval system, the quality of generic drugs ... and accelerate the evaluation of the efficacy and consistency of medicines," Bi said in translated remarks. Release (Chinese language)

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