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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

For Clinical Trials with ATMP: Guidance to the content of the Investigator´s Brochure published

06 March 2026

See the Danish Medicines Agency’s guidance on the content of the Investigator’s Brochure for clinical trials with ATMPs

New functionalities in the CTIS-module Non-substantial modification

09 February 2026

Electronic dispatch of decision letters marks its fifth anniversary

04 February 2026

Expedited Assessment of Clinical Trials in the EU: FAST‑EU Pilot Project Begins on 30 January 2026

23 January 2026