Guideline on the need for non-clinical testing in juvenile animals of pharmaceuticals for paediatric indications

We have adopted this International Scientific Guideline - EMEA/CHMP/SWP/169215/2005

Last updated

22 August 2024

About this guideline

Overseas effective date: 1 August 2008

Categories: Non-clinical | Toxicology | Reproductive / developmental and juvenile toxicity; and Non-clinical | Paediatrics

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 European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

Topics