2024年6月14日 · 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.

Therefore, considerations for further risk reduction (e.g., treatment of raw materials, extensive testing for broad virus detection) should be applied (see Annex 6).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Q5A (R2) Viral Safety Evaluation of Biotechnology Products...

ICH is a consensus-driven process that involves technical experts from regulatory authorities and industry parties in detailed technical and science-based harmonization work that results in the...

The ICH Q5A(R2) guideline establishes harmonized scientific and technical requirements for products derived from characterized cell lines of human or animal origin:

EMA/CHMP/ICH/804363/2022 Page 5/52 1. Introduction This guideline describes the evaluation of the viral safety of biotechnology products including viral clearance and testing, and it outlines what data should be submitted in marketing application s for those products.

•Retains original organisation and scientific principles of ICH Q5A(R1) in the document •Highlights key scientific principles and allows flexibility for evolution of science and knowledge, including risk-based approaches •Supports and encourages use of new technologies to align with

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ich harmonised guideline viral safety evaluation of biotechnology products derived from cell lines of human or animal origin q5a(r2) ich consensus guideline table of contents 1. introduction ..... 5 2.

2022年9月29日 · The ICH Q5A (R2) draft Guideline on Viral Safety Evaluation of Biotechnology Products reached Step 2 of the ICH process on 29 September 2022.