2 Setting up Reporting Destinations
As per the Business rules for E2B(R3) published by MFDS (), the reports have to be submitted to 4 different offices, based on the case data.
Therefore, N.1.4 Batch Receiver Identifier and N.2.r.3 Message Receiver Identifier should have one of the below values:
- Clinical Trial: MFDS-O-CT (Test environment-MFDS-T-CT)
- Compassionate Use: MFDS-O-CU (Test environment-MFDS-T-CU)
- Domestic Post-marketed: MFDS-O-KR (Test environment-MFDS-T-KR)
- Foreign Post-marketed: MFDS-O-FR (Test environment-MFDS-T-FR)
To achieve this, it we recommend that you set up four different Reporting Destinations in Oracle Argus Safety with Agency Identifiers.