China Slashes Drug Backlog with Fast-Track Approvals

China’s Center for Drug Evaluation (CDE) completed 9,680 drug filings in 2017, slashing the backlog of filings to 4,000 from a high of 22,000 in September 2015. A total of 394 market approvals were issued during the year, made up of 278 domestically developed drugs and 116 imports. The CDE has granted fast-track status to more filings, with new drugs making up 45 percent of the total 423 that received the status in 2017. Of the drug registration applications approved in 2017, 88 percent were chemical drug products, with biology drug products and traditional Chinese medicine products accounting for 8 percent and 4 percent respectively. It completed 908 clinical trials of new drugs.