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ICH Topic E 2 A – Clinical safety data management: definitions and standards for expedited reporting

We have adopted this International Scientific Guideline with annotations – ICH E2A; CPMP/ICH/377/95

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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'.

  • 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.
  • All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

For more information see International scientific guidelines adopted in Australia.

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