Guideline on the investigation of medicinal products in the term and preterm neonate

We have adopted this International Scientific Guideline - EMEA/536810/2008

Last updated

20 August 2024

About this guideline

Overseas effective date: 1 January 2010

Categories: Clinical efficacy and safety | 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.

Product types