FDA and EMA Collaborate to Facilitate COVID-19 Vaccine Development


Global regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). This report was the outcome of March 18th first global regulators meeting, chaired jointly by the the U.S Food and Drug Administration (FDA) and the European Medicines Agency (EMA), in which regulatory strategies to facilitate the development of SARS-CoV-2 vaccines were discussed.

More than 60 experts representing 25 agencies and 17 countries participated in the meeting, as well as the World Health Organization. All participants in the meeting acknowledged the urgency of conducting first-in-human clinical trials with COVID-19 vaccine candidates. The conclusions set out how regulatory authorities around the globe intend to strike the balance between rapid development of vaccines and the need to generate enough robust data to enable decision-making.

The meeting also aimed to encourage exchange of information about the global efforts towards developing new vaccines against COVID-19 through an open dialogue between medicines regulatory authorities around the globe.

Read the full Report

Check FDA’s and EMA’s dedicated webpages on COVID-19 for the latest updates.


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