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'.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.