China FDA seeks comments on device, drug approval backlog plans

China FDA has opened a window until Dec. 13 for comments on its plans to whittle down a massive backlog on drug and medical device approval applications. A recent report by Forbes said more than 10,000 new applications are received by the CFDA annually, more than double the number existing staff can handle at the a backlog of just new drugs pending review stands at more than 21,000. CFDA said in a notice that the plan is in line with a State Council directive aimed at accelerating the number of new drugs available as well as bringing generic drugs to the market more quickly. Release (Chinese language)