South Korea MFDS E2B (R3) Export
The Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food & Drug Administration published the Regional implementation guide for E2B (R3) reporting in January 2019 and the Business Rules document in January 2020. The implementation guide defines 14 KR specific E2B (R3) regional data elements, and local guidance business rules regarding submissions of E2B (R3) to the MFDS for South Korea.
The application has been enhanced with the capability to schedule, generate, transmit, track, and submit E2B (R3) reports in accordance with the MFDS E2B (R3) Implementation guide, Business rules, and ICSR Reference instance published by MFDS.
The following is the list of changes made in the application for supporting MFDS E2B (R3):