China FDA faces drain as staff seek higher pay

Research

A flight of highly trained staff at the China FDA threatens to undermine a push to clear a massive backlog of pending drug approval applications and institutional knowledge needed to spot fraud.

Reuters reports that the lure of higher salaries and less official pressure are leading staff to move to companies in the private sector, citing a former senior China FDA official.

"The brain drain of skillful people definitely impacts the CFDA's ability to operate, especially for example its ability to evaluate new drugs," Cheng Gang, a former CFDA section chief who started his own drug company upon leaving in 2014, told Reuters.

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The former official was quoted as saying the pay gap between public service levels of around RMB120,000 ($18,320) annually and the private sector at RMB600,000 ($91,520) provided incentive to leave.

The news agency added that inspectors in particular have left the agency as scandals on quality and safety--including the recent case of illegal sales of vaccines that were past expiry and stored improperly in Shandong province--has brought more top-level scrutiny.

Starting last year, China FDA began a series of reforms aimed at hiring more drug reviewers, planning new facilities to evaluate drugs and stepping up manufacturing and distribution oversight.

The campaigns, closely watched by China's leadership, saw China FDA Commissioner Bi Jingquan in February warn that the regulator will not hesitate to enforce the "most stringent standards" for food, drug and device safety along with the "most severe punishment" for fraud.

Still, gaps in access to cutting-edge drugs in China are blamed on an approval process that can take more than 5 years, with the country reluctant to hire outside vendors for assistance or rely on approval data from abroad for a pharmaceutical market estimated at $150 billion.

Reuters noted that multinational and domestic companies are watching closely as well as they work with a surge of companies that are developing candidates in oncology, diabetes and other therapies onshore or with local partners, citing WuXi AppTec CEO Ge Li.

"China wants to set a standard, but it also needs to have the expertise and the talent," he told Reuters.

- here's the Reuters story carried in the Taipei Times

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