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Backlog cripples China's drug regulator

Unprocessed applications are clogging up China's Food and Drug Administration, delaying the arrival of new drugs to the market, according to a recent report. Chinese drug developers and subsidiaries of multinational pharma companies have long complained about the country's slow drug approval process. But a severe lack of staffing has left the Center for Drug Evaluation of the CFDA with a backlog of applications topping 18,000 at the end of 2014, an increase of more than 4,000 since the end of the previous year. Staff shortages engender problems, such as improper, repetitive applications for generic drugs, and occasionally corruption. Another critical factor in the delay is that drug reviewers carry personal responsibility for their professional decisions with potentially serious consequences for mistakes, intended or not (Nat. Biotechnol. 25, 835–837, 2007). As a result, reviewers must seek supervisory approval for each decision. The CFDA said in January that it plans to reduce the backlog in the next three years by adding personnel and funding, streamlining relevant mechanisms and increasing the speed of review.

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Backlog cripples China's drug regulator. Nat Biotechnol 33, 577 (2015).

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