ICH Topic Q5A (R1) - Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin

We have adopted this International Scientific Guideline – ICH Q5A(R1); CPMP/ICH/295/95

Last updated

9 January 2025

About this guideline

Overseas effective date: October 1997

Categories: ICH | Quality

Biologicals | Finished product | Adventitious agents safety evaluation

TGA Annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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