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Theme

Vaccines against COVID-19

Medicines agencies around the world are collaborating to approve and follow vaccines against COVID-19. Once the vaccines are approved, medicines authorities around the world follow up with monitoring of adverse drug reactions. Read about results, processes and new vaccines against COVID-19 in our three themes or in the question-and-answer below.

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News and notifications

Revised CTIS Sponsor Handbook release

07 July 2025

The revised Sponsor Handbook for the Clinical Trials Information System (CTIS) will be published on the EMA website on Wednesday 9 July 2025. On the same day, a dedicated CTIS bite-size talk takes place at 15:30 CEST.

The Danish Medicines Agency requires bioequivalence data in a better data format

03 July 2025

Call for interest launched for COMBINE pilot exploring the feasibility of coordinated assessment across EU Member States for combined studies

16 June 2025

First common Nordic packages in English approved

20 March 2025