About this guideline
Overseas effective date: June 1995
Provided for information: Published in TGA News in October 2000
Categories: ICH Efficacy | Clinical efficacy and safety
Clinical efficacy and safety | general
TGA Annotations:
The Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (CPMP/ICH/377/95) is an internationally accepted standard for the reporting of important clinical safety information principally arising during clinical development of medicines.
The TGA has adopted the Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting in principle, particularly its definitions and reporting time frames. However, there are some elements of CPMP/ICH/377/95 which have not been adopted by the TGA and other elements which require explanation in terms of 'local regulatory requirements'.
Please refer to :
- 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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For more information see International scientific guidelines adopted in Australia.