ICH Q5(R2) "Viral Safety Evaluation of Biotechnology Products Derived from Cell Line of Human or Animal Origin

The ICH Secretariat is pleased to announce the publication of the ICH Q5A(R2) “Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin” Guideline training materials. Modules 0-3 are designed to be targeted to Industry and Regulatory audiences to clarify and illustrate key concepts specific to Viral Safety that have been updated in the ICH Q5A(R2) guideline revision, which was adopted in November 2023 and to support implementation of the guideline by use of examples (for illustrative purposes).

To download the updated ICH Q5A(R2) training modules, please see the Q5A(R2) IWG webpage on the ICH website.