ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Scientific guideline
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.
Keywords: Viral safety, cell lines qualification, biotechnology, virus clearance
-
List item
ICH: Q 5 A (R2): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Step 2b (PDF/1.14 MB)
Draft: consultation closed
First published: 10/10/2022
Consultation dates: 10/10/2022 to 10/02/2023
EMA/CHMP/ICH/804363/2022 -
List item
Overview of comments received on ICH guideline Q5A (R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin (PDF/975.78 KB)
First published: 27/03/2023
EMA/CHMP/ICH/804363/2022