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

AdoptedLegal effective date: Reference Number: EMA/CHMP/ICH/804363/2022

English (EN) (1.17 MB - PDF)

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

Consultation dates: to Draft: consultation closedReference Number: EMA/CHMP/ICH/804363/2022

English (EN) (1.14 MB - PDF)

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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

English (EN) (1.03 MB - PDF)

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

AdoptedLegal effective date: Reference Number: CPMP/ICH/295/95

English (EN) (292.17 KB - PDF)

First published: Last updated:
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