Guideline on registry-based studies

We have adopted this International Scientific Guideline - EMA/426390/2021

Last updated

18 July 2024

About this guideline

Adopted by the TGA: 11 November 2022

Overseas publication date: 22 October 2021

Categories: Clinical efficacy and safety | general

The general principles of this guideline are adopted.

Sponsors should refer to the TGA pharmacovigilance guidelines Pharmacovigilance responsibilities of medicine sponsors Australian recommendations and requirements for their safety reporting requirements from post-registration studies.

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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