CFDA to Begin Conducting Surprise Inspections
The China Food and Drug Administration will begin conducting unannounced inspections of drugmakers in September.
The CFDA says companies can expect teams of investigators armed with cameras, photocopiers and recording devices to investigate reports of complaints and adverse events and check that firms are following good manufacturing practices. Drugmakers will receive a summary of the inspection results and have an opportunity to correct any problems.
Anyone alerting firms to a surprise inspection risks disciplinary action, including criminal prosecution, the agency warns.
“The violators can have their production and sales licenses temporarily revoked, and thus be unable to continue their business,” says Helen Chen director and partner at L.E.K. Consulting. “They can also be reported to the Public Security Bureau and publicly shamed via press conferences. There are no fees or financial compensations specifically mentioned.”
The guidance follows a May 18 notice that provided information on the inspections.
China has also been stepping up oversight of overseas manufacturing sites. As of last month, the CFDA had conducted 30 foreign inspections this year — 11 more than in all of 2014 (IPRM, July).— Jonathon Shacat and Elizabeth Hollis
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