ICH Q5A(R2) Guideline 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

Current version - effective from 14 June 2024

ICH Q5A(R2) Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Step 5

Adopted Reference Number: EMA/CHMP/ICH/804363/2022 Legal effective date: 14/06/2024

Document history

ICH: Q 5 A (R2): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Step 2b

Draft: consultation closed Consultation dates: 10/10/2022 to 10/02/2023 Reference Number: EMA/CHMP/ICH/804363/2022

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

Reference Number: EMA/73056/2023

ICH: Q 5 A (R1): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Step 5 - first version

Adopted Reference Number: CPMP/ICH/295/95 Legal effective date: 01/10/1997