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EMA – Open consultation on a Reflection paper on lessons learned from the COVID-19 pandemic: Scientific considerations on non-clinical aspects

This reflection paper covers SARS-CoV-2 vaccines and medicinal products intended to prevent or treat COVID-19 and its complications. It focuses on the non-clinical scientific considerations for pivotal, non-clinical data used to support clinical development, marketing authorisation and patient safety in the pandemic setting. Procedural regulatory aspects are not in scope of this document.  The paper identifies a number of learnings from the Covid-19 pandemic which can be considered in order to facilitate efficient and rapid non-clinical development and safety assessment in the future.

The deadline of the consultation is 30 September 2025.

A dedicated page has been released by the EMA on its Website.

Find the templates to answer and more public consultations on the EMA Website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (28 juillet 2025). EMA – Open consultation on a Reflection paper on lessons learned from the COVID-19 pandemic: Scientific considerations on non-clinical aspects. ELSIBI. Consulté le 17 janvier 2026 à l’adresse https://doi.org/10.58079/14fyd


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