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Almost 80% of drugmakers failed surprise inspections, China FDA report reveals

More than half of the drug manufacturers and distributors randomly chosen for inspection did not meet requirements, the China Food and Drug Administration said in its annual drug inspection report released May 31.

In 2016, the administration carried out 434 on-site local and overseas manufacturing inspections, good manufacturing practice certification inspections, unannounced inspections and distribution chain inspections.

The administration also completed 204 follow-up inspections, up 13% compared to 2015, the report said. Out of the total 204 enterprises, 12 failed to meet the requirements and another 58 were issued letters of caution.

Unannounced inspections were carried out on 39 drug manufacturers, of which 14 had their good manufacturing practice licenses revoked, 10 were placed under further investigation and seven had their products recalled. In addition, regulatory authorities carried out unannounced inspections on 50 drug-distributing enterprises, of which 38 were found to have violations, the report added.

At the same-day press conference, China FDA director of drug registration division Ding Jianhua said unannounced inspections are a major highlight of the inspection work in 2016. In the past, the administration had to "put out the fires" after damage had been done already, but in recent years, by carrying out unannounced inspections and discovering problems frequently, the government can warn and educate companies so that risk can be controlled, Ding said.

First released by the China FDA in June 2015, the unannounced inspection provision aims to strengthen the supervision and inspection of drugs and medical devices, and reinforce the prevention and control of safety risks. The law, which came into effect Sept. 1, 2015, allows regulatory authorities from the administration to carry out inspections on the research and development, production, distribution activities, and use of drugs and medical devices without prior notice.

In 2017, the government plans to inspect 466 drug manufacturers, of which 316 will be follow-up inspections, the report added.