TGA Adopts Internationally-Recognized E2B Reporting System
Australia's Therapeutic Goods Administration (TGA) has adopted a "streamlined" way for sponsors to submit adverse event reports for medicines and vaccines, aligning TGA's system with the European Union, the US, Japan and Canada.
Sponsors are now able to submit adverse event reports by email ([email protected]) using the international E2B standard, supported by the International Conference on Harmonization (ICH). Data supplied in this format can be entered directly into the TGA's adverse event database with minimal user interaction.
"The change offers sponsors the potential to avoid double-handling and the need to copy information into Council for International Organizations of Medical Sciences (CIOMS) forms that have been widely used to date," TGA said in a statement.