For Immediate Release: June 24, 2020
The European Union (EU) has long been one of the U.S. Food and Drug Administration's most important collaborators in tackling public heath challenges and working with our counterparts across the Atlantic is a top priority for the agency. To advance this partnership, FDA hosted a virtual bilateral meeting with the European Commission (EC) and the European Medicines Agency (EMA), on June 18-19, 2020, to discuss regulatory cooperation in medical products areas, including issues related to COVID-19.
“The robust relationship with our European colleagues is vital during global public health crises,” said FDA Commissioner Dr. Stephen Hahn, who joined EMA's Executive Director, Professor Guido Rasi, and Dr. Andrzej Rys, Director of Health Systems, Medical Products and Innovation, at the European Commission, in kicking off the meeting. “Now, our many years of working together have prepared us to jointly confront the COVID-19 pandemic. We will continue to partner closely with our European colleagues during this pandemic and on any future situations where collaboration is essential.”
The FDA and the EMA have led COVID-19 discussions under the auspices of the International Coalition of Medicines Regulatory Agencies (ICMRA), which includes 28 regulatory authorities globally, to help expedite and streamline the development of COVID-19 vaccines and therapeutics and support potential alignment of policy approaches. “As two prominent and advanced regulatory systems, FDA and EU have a unique opportunity to not only work toward policy convergence and regulatory harmonization but also to provide global leadership by sharing our expertise with fellow regulators and promoting global collaboration,” said Anna Abram, FDA Deputy Commissioner for Policy, Legislation, and International Affairs.
In addition to discussing the FDA and the EMA's ongoing efforts related to therapeutics and vaccines for COVID-19, the meeting also addressed the use of real-world data coupled with modern, rigorous analytical methods to potentially provide actionable information to support our COVID-19 response, something of great interest globally. FDA's Principal Deputy Commissioner, Dr. Amy Abernethy, presented FDA's efforts in that area.
Medical devices have recently returned to the EC's health portfolio, so in addition to highlighting the challenges for medical devices during the pandemic, the FDA and the EC also discussed strengthening ongoing collaborations through the International Medical Device Regulators Forum (IMDRF) and the Medical Device Single Audit Program (MDSAP) to accelerate international regulatory harmonization, support medical device innovation, and maximize public health and safety.
Since the last bilateral meeting in 2018, the FDA and the EU finalized their preliminary assessments under the Pharmaceutical Annex to the U.S.-EU Mutual Recognition Agreement (MRA), which allows drug inspectors to rely on information from certain types of manufacturing inspections conducted within each other's borders to yield significant efficiencies and enable regulators to focus resources on other regions of higher risk. The current meeting offered an opportunity for both the FDA and the EMA to assess the MRA's benefits.
These important partnerships between FDA and European counterparts continue to be supported by FDA's Europe Office, through which we forge stronger working relations and help ensure that our collaboration is delivering on agreed strategic priorities to the benefit of public health.
Contact us at US-FDA-EUR@fda.hhs.gov if you have questions or comments.