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

About this guideline

Overseas effective date: 1 June 2014

Categories: Nonclinical | Pharmacology | Nonclinical | General (nonclinical)

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

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For more information see International scientific guidelines adopted in Australia.

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.