CFDA eyes new Shanghai evaluation center to speed drug approvals

Shanghai will build a China FDA medicine evaluation center to speed drug approvals, CNTV said on its website, as part of efforts to keep and attract drug and device firms to the region. China has struggled with a backlog of more than 18,500 drugs awaiting approval by the end of 2014, an increase of 33% from the previous year, according to the China FDA's Center for Drug Evaluation in April. A timeframe was not immediately available for the new center. In May, the country hiked fees to register medicines and devices as part of efforts to fund faster approvals. According to CNTV, the CFDA says the process of clinical trial and production application takes 240 working days in total. But domestic and multinational companies complain the waits are often double. CNTV says one key reason for delays is that CFDA has around 120 staff handling evaluations, compared to thousands at the U.S. FDA. Report

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