The European Commission, EMA and FDA held their 2020 bilateral regulatory dialogue meeting on 18 and 19 June


Senior Officials from the European Commission (DG SANTE), European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) held their 2020 bilateral regulatory dialogue meeting on 18 and 19 June. During this virtual two-day meeting, the regulatory authorities reviewed their ongoing joint initiatives, discussed strategic priorities for the coming years and identified collaboration to be further strengthened in medical products areas, including issues related to COVID-19.

The European Commission (DG SANTE), EMA and FDA have discussed five main topics, in particular:

  1. Sharing of experience and common challenges to facilitate the development, review and availability of COVID-19 vaccines;
  2. Opportunities for cooperation on individualised/bespoke therapies for ultrarare diseases (e.g. gene therapies (advanced therapies/ATMPs); oligonucleotides) to jointly address their scientific and regulatory challenges;
  3. The development of a roadmap for international collaboration in the field of real world evidence (RWE) use to support regulatory decisions in the fight against COVID-19;
  4. The expansion of the Mutual recognition agreement (MRA) of good manufacturing practice (GMP) to include veterinary medicines, vaccines and plasma-derived products by July 2022.;
  5. Cooperation and information sharing on orphan and paediatric medicines, especially in the area of data analysis for the characterisation of rare diseases.

Given the medical emergency presented by COVID-19 and the importance of international cooperation to deal with this global pandemic, the topic figured prominently on the agenda of the bilateral meeting. Against this backdrop, cooperation between regulatory bodies across the Atlantic has been strengthened to ease the exchange of best practices and prepare the ground for joint actions on COVID-19.

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