EMA: Ireland’s Emer Cooke Set to Take the Helm


The European Medicines Agency (EMA), Europe’s regulatory body for medicines, has nominated Irish candidate Emer Cooke to as its new executive director at a crucial time for the agency as its powers and priorities shift in the wake of the COVID-19 crisis.


If Cooke accepts and gives an official statement before the European Parliament Committee on Environment, Public Health and Food Safety (ENVI), on July 13th she is set to begin her new role with the regulatory agency in the summer of 2020. 


Cooke is an Irish national and has served as the director of the WHO’s Regulation and Prequalification Department since 2016. Her experience in this role includes overseeing health technologies, including strengthening regulatory systems, quality and safety assurance, and efficacy. Prior to her current role, she worked in leadership positions at the European Commission. She will be returning to the EMA, where she worked as Head of Inspections and Head of International Affairs from 2002 to 2016. 


If she accepts the new role, Cooke will be based in Amsterdam, where the EMA has been located since March 2019 after leaving its London offices in the runup to Brexit. She will be replacing current executive director Guido Rasi, who is currently serving in his second term after being appointed in November 2015. July 13. An overlap period with Rasi, is expected who has previously expressed his desire for a long handover period which would give him time to train his successor. In Rasi’s final year as executive director, the agency recommended 66 medicines for marketing authorisation, including seven orphan drugs and a conditional authorisation for the first Ebola virus vaccine.


Cooke will have a great deal of responsibility around increasing transparency for medicines and vaccines targeting COVID-19, with the main objectives including the publication of clinical data for products. The agency is currently operating under a continuity plan to ensure that public health regulation continues to be carried out and to avoid potential delays or medicine shortages. The EMA is working to more quickly assess promising investigational medicines during the pandemic and has introduced a new fee structure for marketing authorisation applications for these drugs.

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