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

CPMP/ICH/377/95 adopted by the Therapeutic Goods Administration (TGA)

About this guideline

Overseas effective date: 1 Aug 2000

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

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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.

This webpage on the TGA website was printed on 10 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/resources/resource/international-scientific-guidelines/international-scientific-guideline-note-guidance-clinical-safety-data-management-definitions-and-standards-expedited-reporting-annotated-tga-comments

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