Guideline on non-clinical testing for inadvertent germline transmission of gene transfer vectors

We have adopted this International Scientific Guideline - EMEA/273974/2005.

Last updated

4 June 2024

About this guideline

Overseas effective date: 1 May 2007

Categories: Multidisciplinary | Gene therapy, and Non-clinical | toxicology | Reproductive / developmental and juvenile toxicity

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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