Points to consider on application with 1. meta-analyses; 2. one pivotal study

We have adopted this International Scientific Guideline - CPMP/EWP/2330/99

Last updated

17 January 2025

About this guideline

Overseas effective date: 1 May 2001

Categories: Clinical efficacy and safety | Biostatistics

TGA annotations:

Sponsors are reminded that they should submit all available new safety data that are relevant to the intended treatment population.

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