Guideline on the non-clinical studies required before first clinical use of gene therapy medicinal products

We have adopted this International Scientific Guideline - EMEA/CHMP/GTWP/125459/2006

Last updated

22 August 2024

About this guideline

Overseas effective date: November 2008

Categories: Non-clinical | Toxicology;

Non-clinical | Non-clinical development;

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.
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