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FDA and EMA agree to intensify collaboration during COVID-19 pandemic

Published on 23/06/20 at 10:21am
Photo by FDA

Senior officials from the US Food and Drug Administration and the European Medicines Agency have pledged to continue working closely together through the current pandemic.

The two agencies began working together in 2003 and have almost daily interactions. These are structured around working groups that collaborate with international regulators to better align their policies.

Combined with the European Commission, the pair has had more regular interactions during the coronavirus pandemic under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).

During their bilateral regulatory dialogue meeting on 18 and 19 June, they discussed multiple issues and pledged to tackle some of the new complications caused by COVID-19.

They discussed coronavirus vaccines, therapies for rare diseases and closer sharing on information on orphan and paediatric medicines and the possible cooperation in the area of data analysis for the characterisation of rare diseases.

They also have agreed to collaborate on the use of real world data and observational research on COVID-19, in particular regard to vaccine surveillance. Their discussion focused on data provenance, quality and structure, on methods for generating evidence and opportunities to strengthen collaboration leveraging data from diverse digital sources to inform regulatory decisions.

Conor Kavanagh

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