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ICH guideline S6 (R1) - preclinical safety evaluation of biotechnology-derived pharmaceuticals

We have adopted this International Scientific Guideline – ICH S6 (R1); EMA/CHMP/ICH/731268/1998 

Last updated

About this guideline

Overseas effective date:  December 2011

Replaces: CPMP/ICH/302/95. Note for Guidance on Preclinical Safety Evaluation of Biotechnology Derived Pharmaceutical (Adopted by TGA 1 October 1999)

Categories: ICH | Safety

Non-clinical development

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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For more information see International scientific guidelines adopted in Australia.

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