CFDA Approvals See First Increase Since 2011


Reversing the trend seen over the last few years, approvals for new drug products and clinical trials in China rose in 2014.

The increase could represent less a true increase and more a normalization of review and approval rates, suggested Carl Williams, a former US FDA investigator with experience in China. The CFDA’s increased attention to GMP compliance likely was the source of the decreases in approvals seen since 2011, he said. Chinese regulators seem to be growing more adept at enforcing GMP compliance in alignment with the US and EU; likewise, manufacturers in China are developing stronger GMP compliance systems. “Some of the GMP stumbling blocks that held up approvals or clinical trials in the past may be starting to get corrected before filings are made to the CFDA,” Williams speculated.

The greatest increases were seen in new generic approvals, which grew from 187 in 2013 to 256 in 2014 (see table below). New chemical entities came in second at 128, up from 91 in 2013. Traditional Chinese medicines (TCMs) saw the greatest decrease, from 27 approvals in 2013 to just 11 last year.

Despite the increase in new product approvals, the CFDA still closed out 2014 with a significant backlog: 18,597 applications, up from the 14,235 it had at the end of 2013.

This posting is taken from an article in the June 2015 issue of Emerging Markets Outsourcing Report. The full article addresses the increase in interest in conducting clinical trials in China. To learn more, click here.

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Jim Miller is the founder and president of PharmSource Information Services, Inc. A preeminent expert in bio/pharmaceutical outsourcing, Jim established and presides over the industry’s principal resource for serious consumers of information on contract drug development and manufacturing, PharmSource STRATEGIC ADVANTAGE. He is editor and publisher of Bio/Pharmaceutical Outsourcing Report and Emerging Markets Outsourcing Report.

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