FDA, EU Members to Share Inspection Duties

FiercePharma Manufacturing

December 24, 2013

The Food and Drug Administration (FDA) is beefing up its overseas inspection staffs in places like China and India, countries that supply a lot of products where the FDA sees risks to quality. But as global production continues to rapidly expand, the FDA is also looking for ways to work with regulators around the world to share some of the burden. It has now kicked off a program with half a dozen players in the European Union (EU) to do that with the oversight of generic drugmakers.

The FDA, the European Medicines Agency (EMA), and regulators from the United Kingdom, France, Germany, Italy and the Netherlands have agreed to share information on what they discover when looking over clinical or analytical facilities during inspections of bioequivalence studies. Streamlining the process for regulators should hasten approvals of safe and effective drugs for consumers, the FDA said. They are starting with an 18-month pilot program to share information on inspections of facilities used in clinical trials for generic drugs.

"Our continued collaboration with the EMA and the EU enhances our ability to leverage inspection resources and helps us meet the challenges of increased globalization in drug development," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "By streamlining the inspection process for generic drug applications, we will help consumers gain access to safe and effective generic drugs."

Among the objectives, the FDA says, is to streamline information sharing on inspections of bioequivalence studies for generic drug applications, make sure agencies pass along any problems they uncover during an inspection and to do some joint inspections.

The FDA has been looking at ways to better cooperate since 2008, when tainted Chinese heparin led to deaths of dozens of patients and made the agency realize it needed more resources to watch over foreign production. While this kind of cooperation seems like a no-brainer, it comes with its own complications. The pharma industry wants to make sure that trade secrets are not divulged during all of this information sharing.

The agreement is on top of the FDA's expansion of its foreign inspection staff. It intends to station another nine drug inspectors in China. It has been working to do that for a year, but China has been sitting on visa applications. U.S. Vice President Joe Biden managed to break that logjam during his recent visit there. The FDA also has been adding to the number of inspectors it has living in India, a major producer of generic drugs.

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