FDA Overviews New EU-US MRA on GMP

In February 2017, regulatory authorities in the European Union and the United States signed a mutual recognition agreement (MRA) on good manufacturing practice inspections to maximize inspection capacity, reduce duplication, and encourage greater international harmonization. Ms. Dara Corrigan, Associate Commissioner for Global Regulatory Policy in the FDA Office of Global Regulatory Operations and Policy, is responsible for the FDA’s Mutual Reliance Initiative with the EU. “Industry can expect that duplicative inspections will decrease significantly in the EU and in the US, and that those inspection resources will be deployed in areas of higher risk outside of the US and EU,” she explains. “For the industry, that is a benefit. For our consumers and patients in the EU and the US, it is a huge benefit.” Have additional questions? Join us at the CMC Workshop for a Regulators Update, or during the EMA/FDA Question Time session at our DIA 2017 Global Annual Meeting!