EMA and FDA agree new priorities, including research on COVID-19

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At the 2020 bilateral regulatory dialogue meeting, senior officials from the European Commission, European Medicines Agency (EMA) and US Food and Drug Administration (FDA) identified new strategic priorities for medicines.

Shaking hands V13D29

The meeting, which was hosted virtually on 18 and 19 June 2020, was attended by senior officials from the European Commission Directorate General for Health and Food Safety (EC DG SANTE), EMA and FDA.

The meeting marks 17 years since the formal start of the collaboration between EMA and FDA. Frequent interactions between the two agencies aim to align and advance their scientific and regulatory work.

The meeting included a review of existing initiatives, discussion of areas where collaboration can be improved, and identification of new strategic priorities for the future.

Much of the discussion of course focused on the COVID-19 pandemic, as a result of which the EC, EMA and FDA have intensified their collaborations via the International Coalition of Medicines Regulatory Authorities (ICMRA).

Highlights from the discussion were presented by an article recently published by EMA.

Topics of discussion related to COVID-19 included:

  • Vaccines: The agencies agreed to share their experiences in facilitating the development and review of vaccines against SARS-CoV-2.
  • Observational research: They agreed to collaborate on observational research on COVID-19 (specifically on vaccine surveillance, building international cohorts, and use of medicines in pregnant women with COVID-19). This will serve as a model for the use of real-world evidence to support regulatory decisions, with EMA and FDA agreeing to jointly develop a roadmap for international collaboration on real-world evidence.

Other topics of discussion included:

  • Personalized therapies for rare diseases: The agencies discussed the scientific and regulatory challenges of individualized therapies for ultra-rare diseases, such as gene therapies.
  • Mutual recognition agreement (MRA) for good manufacturing practice (GMP) inspections: In 2019, FDA and EMA signed an MRA meaning that GMP inspections carried out in the EU are recognized in the US, and vice versa [1]. At the latest meeting, the agencies discussed expanding the MRA to veterinary medicines as well as vaccine and plasma-derived products like antibodies. A preliminary deadline for this has been set of July 2022.
  • Orphan medicines: The agencies discussed information sharing initiatives and cooperating on data analysis for the characterization of rare diseases.

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1. GaBI Online - Generics and Biosimilars Initiative. US and EU sign milestone mutual recognition agreement [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 10]. Available from: www.gabionline.net/Policies-Legislation/US-and-EU-sign-milestone-mutual-recognition-agreement

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Source: EMA

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