EMA – Publication of the ICH Q5A(R2) Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
This document considers testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin. It outlines data that should be submitted in the marketing application/registration package.
The ICH Q5A(R2) Guideline will come into effect on 14 June 2024.
More information on the EMA website.
OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (31 mai 2024). EMA – Publication of the ICH Q5A(R2) Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. ELSIBI. Consulté le 18 février 2026 à l’adresse https://doi.org/10.58079/11rmx





