EU and US Discuss Regulatory Collaboration

Members of the European Commission, the European Medicines Agency, and the US FDA held their 2020 bilateral regulatory meeting virtually from June 18–19, 2020. The agencies discussed ongoing joint initiatives and strategies for collaborating in the future.

The agencies, which have been collaborating since 2003 with daily interactions and working groups, have been working more closely amid the COVID-19 pandemic, specifically through the International Coalition of Medicines Regulatory Authorities. Among the topics discussed at the meeting, therefore, was the development of a COVID-19 vaccine. The agencies also discussed the use of real-world evidence to support regulatory decisions and agreed to use observational research in COVID-19 as a model. The focus of these discussions was on data provenance, quality, and structure, as well as methods for generating evidence and leveraging data from diverse digital sources.

In addition, therapies for ultrarare diseases, orphan and pediatric medicines, and expansion of the mutual recognition agreement were discussed.