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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

New functionalities in the CTIS-module Non-substantial modification

09 February 2026

It is now possible to submit non-substantial modifications, where it earlier required submission of a substantial modification. It includes amongst others the prolongation of the clinical trial duration. See the full list of functionalities below and on our homepage.

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

Updating of summaries of product characteristics due to changed ATC codes for 2026

05 January 2026