Partnering with the European Union and Global Regulators on COVID-19 – FDA.gov

By: Anna Abram, Deputy Commissioner for Policy, Legislation, and International Affairs and Mark Abdoo, Associate Commissioner for Global Policy and Strategy

The European Union (EU) is one of the U.S. Food and Drug Administrations most important collaborators in tackling public heath challenges. The FDA and the European Commission (EC) and its European Medicines Agency (EMA) have long leveraged each others expertise and experience to promote the safety, effectiveness, and quality of medical products to advance the health of our citizens. Now, our work, built together over more than a decade, has paved the way for a multitude of critical collaborations on many scientific and regulatory fronts as part of our COVID-19 response.

What has helped drive this collaboration are the 30 technical expert groups, or clusters that the FDA and the EMA have established since 2003. These clusters meet regularly for regulatory discussions held under confidentiality commitments and were well positioned to pivot to focus on COVID-19 because of our ongoing work together. Since the start of the pandemic, many of these groups which often also include regulatory authorities from Japan, Canada, Australia, and other countries have shifted their work priorities to focus on COVID-19. For example, our expert group on vaccines has expanded into a multilateral forum to discuss regulatory issues related to the development of SARS-CoV-2 vaccines, whereas the pharmacovigilance group has begun to identify opportunities for collaboration on observational studies related to COVID-19 natural history and interventions. Similarly, our standing meetings on blood products are now focusing on developments related to COVID-19 convalescent plasma. The drug shortages discussions revolve around information sharing on strategies for COVID-19 related shortages and supply disruptions of medicines.

In these expert group discussions, the FDA and the EMA have been exchanging information on the rapidly evolving scientific landscape of products and clinical trials and, as possible, discussing the interpretation of data supporting regulatory decisions. For example, two days after the release of results from a clinical trial that the National Institute of Allergies and Infectious Diseases (NIAID-ACTT study) conducted, the FDA authorized the emergency use of the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. The FDA subsequently hosted a virtual meeting of key regulatory partners, including from Europe, Canada, and Japan, to discuss the safety and efficacy of remdesivir as a treatment for COVID-19. At the time, Japan had announced their version of early access to the drug and most of the other participating authorities were about to begin their own reviews for making such a decision, with EMA issuing a recommendation to expand remdesivir compassionate use shortly thereafter.

Against this backdrop of robust collaboration, on June 18-19, the FDA hosted virtual bilateral meetings with the EC and EMA to review progress on ongoing activities and share horizon scanning across high-priority areas. For example, public and private sector entities are proactively exploring strategic partnerships to address the anticipated challenges related to manufacturing and rapid scale-up of potential COVID-19 vaccines or therapeutics. As two-prominent international regulatory bodies, the FDA and the EC/EMA can help inform global regulatory strategies to accelerate production and global access of products. In addition, the application of real-world data to understand the natural history of COVID-19, treatment patterns, and the performance of diagnostics is of keen interest for both the FDA and the EU.

The FDA and the EU are also promoting engagement with global regulators, under the International Coalition of Medicines Regulatory Authorities (ICMRA) forum, which is comprised of 28 regulatory authorities from around the globe. For example, in March, as vaccine candidates began to be identified, the FDA and the EMA jointly chaired the first global regulators meeting to discuss regulatory strategies to facilitate the development of SARS-CoV-2 vaccines. Subsequent ICMRA workshops that are focused on COVID-19 therapeutic development, observational studies, and real-world data as well as policy approaches are helping to support mutual awareness and consideration of potential guidance alignment. Such vigorous efforts are reflected in the ICMRA joint statement, which was issued in April 2020, with global regulatory authorities expressing their collective support in countering COVID-19.

To maintain strong oversight of foreign-manufactured medical products, the FDA is leveraging inspection reports completed by the EU and United Kingdom under the Pharmaceutical Annex to the US-EU Mutual Recognition Agreement (MRA). The MRA creates an environment in which FDA and the EU may rely on inspections performed by each others regulatory authorities to inform our regulatory decisions, such as drug approvals or addressing drug shortages.

We are also leveraging our international collaborations in our medical device work. The FDA and global partners (including the EC and other European partners) regularly exchange information on medical device safety issues and regulatory developments. These international relationships have never been more important as we work to maintain critical supplies of medical devices such as personal protective equipment, ventilators and ventilator accessories, as well as diagnostic testing supplies and test kits for COVID-19. Our interactions have included working through our embassies and European contacts to address supply chain disruptions, medical device shortages, and removal of fraudulent and poor-quality products from the market. Moving forward, shared learnings about antibody tests, otherwise known as serology tests their validation, results of ongoing epidemiological studies, and potential use in broader testing programs will inform our continued efforts to confront this pandemic.

Our work in these endeavors is, as always, rooted in the FDAs unwavering commitment to helping to foster the development of safe and effective medical products. We recognize the shared challenges of public health authorities across the world in fighting this pandemic as well as the tremendous opportunities to accelerate our mission critical work through robust scientific collaboration. We will continue to collaborate with our global regulatory counterparts as we seek to bring safe and effective COVID-19 vaccines and treatments to our citizens as quickly as possible and as part of advancing our vital mission to protect and promote public health.

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Partnering with the European Union and Global Regulators on COVID-19 - FDA.gov