ICH Guideline Q5A(R2) on Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

27 March 2023 – the EMA updated scientific guideline on ICH Q5A(R2).

Overview of comments received on ICH guideline Q5A (R2) on Viral safety evaluation of biotechnology products derived from cell lines for Human or Animal origin was published. This document considers testing and evaluation of the viral safety of biotechnology products derived from characterized cell lines of human or animal origin. It outlines data that should be submitted in the marketing application/registration package.

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