International scientific guideline: Guideline on registry-based studies

About this guideline

TGA adopted date: 11 Nov 2022

Overseas effective date: 16 Sep 2021

Categories: Pharmacovigilance

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TGA annotations

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.

For more information see International scientific guidelines adopted in Australia.

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.