Nonclinical Biodistribution Considerations for Gene Therapy Products S12

We have adopted this International Scientific Guideline – ICH - S12

About this guideline

Adopted by the TGA: 13 March 2025

Overseas effective date: 14 March 2023

Categories: ICH | Safety

Multidisciplinary | Gene therapy

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.
All documents and other content published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) on this website are under the copyright and other intellectual property rights ownership of the ICH. Please refer to ICH Official web site : ICH for further information.

Product types

Topics