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 Derived from Cell Lines of Human or Animal Origin.”
The guidance was prepared under the auspices of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The guidance is intended to describe risk-based principles and mitigation strategies to assure the viral safety of biotechnology products, including the data necessary to submit in a marketing application.
The guidance also finalizes the updates based on advances in scientific knowledge and regulatory expectations to the first version of the ICH guidance for industry “Q5A Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin,” issued in September 1998. Lastly, the guidance replaces the draft guidance “Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin” issued on November 14, 2022
Takeaway:
This guidance 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 applications for those products. Biotechnology products include biotherapeutics and certain biological products derived from cell lines of human or animal origin (e.g., mammalian, avian, insect).
In this guidance, the term virus excludes nonconventional transmissible agents like those associated with mammalian prions (e.g., bovine spongiform encephalopathy, scrapie). Applicants are encouraged to discuss transmissible spongiform encephalopathy associated issues with the appropriate regulatory authorities because they are not in scope of
this guidance
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