TGA offers sponsors a streamlined way to submit adverse event reports
- Dedicated email for XML submissions
The TGA has set up a dedicated email: email@example.com for sponsors to submit adverse event reports using the E2B format.
- Pharmacovigilance responsibilities
The Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines sets out requirements and guidance for the reporting of adverse reactions and significant safety issues for both registered and listed medicines regulated by the Therapeutic Goods Administration.
The TGA has introduced a streamlined way for sponsors to submit adverse event reports regarding medicines and vaccines which will make it easier to meet mandatory reporting requirements.
Manual data entry and double-handling will be reduced, with sponsors now able to submit adverse event reports via email: firstname.lastname@example.org using the widely used international E2B standard. Data supplied in this format can be entered directly into the TGA's adverse event database with minimal user interaction.
Most sponsors who currently transmit Individual Case Safety Reports (ICSRs) electronically to regulatory authorities around the world use the same E2B standard being introduced by the TGA. 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.
The TGA will benefit by reducing the manual data entry of CIOMS forms submitted by sponsors and the potential for errors. These forms represent about 50 per cent (7,000-8,000) of the annual volume of adverse event reports received by the TGA.
The TGA is continuing to work towards removing barriers to information exchange relating to adverse event reporting.
Sponsors of all medicines on the Australian Register of Therapeutic Goods (ARTG) are reminded that they have mandatory reporting requirements as described in the TGA document Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines.
The TGA has set up a dedicated email address (email@example.com) for sponsors to submit adverse event reports using the E2B format.
Note: The existing methods for sponsors to submit adverse event reports will continue to be available.