Registration for E2B R2 adverse event reporting

You will need to carry out testing with the TGA to ensure that you meet the requirements and that your systems are compatible.

You need to follow this process to start using the E2B (R2) EDI service:

1. Familiarise yourself and ensure your system complies with the following formatting standards:
   • ICH ICSR DTD
   • TGA specific validation rules specified.
   • Coding standards specified by the Medical Dictionary for Regulatory Activities.
2. Complete the registration process. The registration process will include:
   • Emailing us to register your interest in E2B R2 adverse event reporting.
   • The exchange of technical and contact details using TGAs template form.
   • The exchange of relevant digital certificates used for authentication and signing.
   • The nomination of earliest and preferred dates for testing.
   • The establishment of a new connection in the TGA system for your organisation.
   • The establishment of a new connection for TGA in your system.
3. Successfully transmit test cases to the test E2B (R2) EDI service after establishment of the connection:
   • The required test scenarios for sponsors to complete are described below.
   • Send an email after you have submitted the test scenarios.
   • We will advise you on the outcome of the testing.
   • Contact TGA via email if you encounter any issues during testing.
4. Following successful testing, you will be able to use the production E2B (R2) EDI service.

You can continue to send adverse event reports using the TGA online reporting form while you set up for E2B (R2) reporting.