FDA Announces New Initiative on Pharma Regulatory Cooperation With European Union
The Food and Drug Administration will expand cooperation with European regulators on pharmaceuticals, in an initiative announced in May 12 by Howard Sklamberg. FDA will be deploying a “dedicated FDA team to work with our European counterparts on a host of issues,” he said. The team will include officials from FDA’s Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, and Office of Global Regulatory Operations and Policy. “Through this initiative, and in cooperation with the European Commission (EC) and the European Medicines Agency (EMA), FDA will aim to deepen our reliance on trusted regulators outside of the U.S. who provide equivalent public safety and quality protection,” said Sklamberg.
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In a letter sent to FDA staff, officials at the agency said the initiative will complement FDA’s work“to enhance pharmaceutical quality through international collaboration, and also FDA’s work in implementing the FDA Safety and Innovation Act.” The FDA Safety and Innovation Act, enacted in 2012, increases FDA’s ability to partner with foreign regulatory authorities on information-sharing and recognition of foreign inspections. Both the letter and the blog post were scant on details, but the letter said more information will be available “as the team embarks on its first set of activities.”