1. South Korea MFDS E2B(R3) Best Practices
  2. Reporting rules setup

4 Reporting rules setup

Each report to MFDS has to be routed to CT/CU/KR/FR/CF Receiver Identifier depending on the case data such as Primary Reporter Country, Report Type, Observe Study Type.

You should set up the reporting rules with advanced conditions in Oracle Argus Safety.

Below are some sample reporting rules for understanding:

Country License type Agency Rule name Timeframe calendar days Advanced condition
South Korea Marketed Drug MFDS-O-KR Serious ADR Domestic 15

Primary Reporter Country = South Korea

Report Type = Spontaneous
Germany Marketed Drug MFDS-O-FR Serious ADR Foreign 15

Primary Reporter Country <> South Korea

Report Type = Spontaneous
South Korea Investigational Drug MFDS-O-CT Death/LT SUSAR 7

Primary Reporter Country = South Korea

Report Type = Sponsored Trial

Observe Study Type = Clinical Trial

South Korea Investigational Drug MFDS-O-CT Serious Unexpected MFDS Clinical Trial rule 15

Primary Reporter Country = South Korea

Report Type = Sponsored Trial

Observe Study Type = Clinical Trial

Germany Investigational Drug MFDS-O-CF Death/LT SUSAR 7

Primary Reporter Country <> South Korea

Report Type = Sponsored Trial

Observe Study Type = Clinical Trial
Germany Investigational Drug MFDS-O-CF SUSAR MFDS Clinical Trial rule 15

Primary Reporter Country <> South Korea

Report Type = Sponsored Trial

Observe Study Type = Clinical Trial
South Korea Investigational Drug MFDS-O-CU SUSAR MFDS Therapeutic Study rule 15

Primary Reporter Country = South Korea

Report Type = Sponsored Trial

Observe Study Type = Compassionate Use
European Union Investigational Drug MFDS-O-CU SUSAR MFDS Therapeutic Study rule 15

Primary Reporter Country <> South Korea

Report Type = Sponsored Trial

Observe Study Type = Compassionate Use
South Korea Marketed Drug MFDS-O-KR SADR domestic 15

Primary Reporter Country = South Korea

Report Type = Sponsored Trial

Observe Study Type = Other Studies
South Korea Marketed Drug MFDS-O-FR SADR foreign 15

Primary Reporter Country <> South Korea

Report Type = Sponsored Trial

Observe Study Type = Other Studies

The following types of cases and criteria need to be met:

Cases Criteria
KR case (Domestic Post Marketed)
  • cases that have REPORTTYPE [C.1.3] = 2, OBSERVESTUDYTYPE [C.5.4] = 3 and REPORTERCOUNTRYR3 [C.2.r.3] for Primary Reporter = KR
  • cases that have REPORTTYPE [C.1.3] <> 2 and REPORTERCOUNTRYR3 [C.2.r.3] for Primary Reporter = KR
FR case (Foreign Post Marketed)
  • cases that have REPORTTYPE [C.1.3] = 2, OBSERVESTUDYTYPE [C.5.4] = 3 and REPORTERCOUNTRYR3 [C.2.r.3] for Primary Reporter <> KR
  • cases that have REPORTTYPE [C.1.3] <> 2 and REPORTERCOUNTRYR3 [C.2.r.3] for Primary Reporter <> KR
CT case (Clinical Trial Domestic)
  • cases that have REPORTTYPE [C.1.3] = 2, OBSERVESTUDYTYPE [C.5.4] = 1 and REPORTERCOUNTRYR3 [C.2.r.3] for Primary Reporter = KR
CF case (Clinical Trial Foreign)
  • cases that have REPORTTYPE [C.1.3] = 2, OBSERVESTUDYTYPE [C.5.4] = 1 and REPORTERCOUNTRYR3 [C.2.r.3] for Primary Reporter <> KR
CU case (Compassionate Use)
  • cases that have REPORTTYPE [C.1.3] = 2 and OBSERVESTUDYTYPE [C.5.4] = 2