Recent Agreement With EU to Allow Increase in Inspections of China, India Drug Facilities, FDA Official Says
A 2017 update to the mutual recognition arrangement (MRA) on pharmaceuticals between the U.S. and the European Union will allow the Food and Drug Administration to dramatically increase inspections of drug facilities in China and India, said Dara Corrigan, FDA’s…
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acting deputy commissioner for Global Regulatory Operations and Policy, in recent remarks (here) at the Food and Drug Law Institute’s annual conference. The agreement, which provides for recognition of EU inspections of its own drug facilities, means FDA can instead allocate its inspectors elsewhere. In 2016, for example, FDA would have been able to nearly double its inspections in China and India had the amended MRA with the EU already been in place, it said. FDA also posted the presentation that accompanied Corrigan’s remarks (here).