ICH - Q5A(R2) draft Guideline on Viral Safety Evaluation of Biotechnology Products reached Step 2

19th October 2022

ICH

The R2 revision retains key principles of the original Guideline and provides additional recommendations on the established and complementary approaches to control the potential viral contamination of biotechnology products.

A Step 2 Informational Presentation has been developed by the Q5A(R2) EWG to summarise the content of the draft Guideline.

Further information can be found on the Q5A(R2) page, including the draft Guideline and the Step 2 Informational Presentation available for download. 

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