FDA Blog Examines Inspection Expansion in the EU

December 7, 2016

Dara Corrigan examines the Mutual Reliance Initiative as a method for expanding FDA’s inspection capabilities in Europe and beyond.

In a Dec. 7, 2016 post on FDA’s Voice Blog, Dara Corrigan, JD, associate commissioner for Global Regulatory Policy at FDA, discussed the agency’s work towards expanding inspection capabilities in the European Union and beyond. One way FDA is attempting to meet this challenge is with the Mutual Reliance Initiative (MRI), Corrigan said.

“The concept is simple. EU country inspectors inspect in their respective countries, FDA inspects the manufacturing facilities in the US, and the EU and FDA would rely upon each other,” Corrigan wrote. “This would avoid duplication, lower costs, and enable the regulators to devote more resources to other parts of the world where there is greater risk.”

MRI was launched in May 2014, and FDA and the EU have had multiple opportunities to assess the risks and benefits of entering a “mutual recognition agreement.” FDA has observed multiple EU facility inspections. “This unprecedented access allows FDA observers to gather firsthand knowledge of the laws that govern EU GMP drug inspections and how inspectorates manage the drug inventory within their respective borders,” Corrigan wrote.

Corrigan also noted that she does not expect Brexit to impact FDA’s relationship with United Kingdom regulatory authorities. When the UK finalizes its exit from the EU, Corrigan said FDA will “examine existing commitments and, if necessary, renegotiate any existing agreements.”

Looking to the future, Corrigan said FDA hopes to sign an agreement with the EU. She wrote, “These collaborations will enhance our ability to evaluate risk, produce better data, and minimize public health risk globally. Indeed, the need to engage globally in different ways is imperative. With MRI, we are moving boldly forward in that direction.”

Source: FDA Voice Blog