ICH Q5A (R2) On Biologics Viral Safety: The Changes, Challenges & Opportunities

Globally harmonized guidance on evaluating the viral safety of biotechnology products has undergone major revisions for the first time in over two decades to address a raft of scientific advances. Manjula Aysola explores the changes and their impact for manufacturers.

ICH Q5A (R2) aligns global regulatory expectations regarding viral safety of biologics • Source: Shutterstock

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