International scientific guideline: Note For guidance on clinical safety data management: Definitions and standards for expedited reporting - Annotated with TGA comments

About this guideline

Overseas effective date: 1 Aug 2000

Categories: Clinical efficacy and safety | General (clinical) | Pharmacovigilance

Access this international scientific guideline

Further information

Published: TGA News October 2000

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.