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EMA – Publication of the Overview of comments on the ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin

The draft document of the ICH Guideline Q5A(R2) was released for consultation on 10 October 2022. Stakeholders had until 10 February 2023 to address their comments and remarks.

The overview of comments is now available on the EMA Website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (4 mai 2023). EMA – Publication of the Overview of comments on the ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/o69r


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