4 Reporting Rules setup

Each report to MFDS has to be routed to CT/CU/KR/FR Receiver Identifier depending on the case data such as Drug/Vaccine license country, Report type, Primary reporter country, Type of study.

We recommend that you set up Reporting Rules with Advanced Conditions in Oracle Argus Safety.

Below are 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
South Korea	Investigational Drug	MFDS-O-CT	Serious Unexpected MFDS Clinical Trial rule	15	Primary Reporter Country = South Korea Report Type = Sponsored Trial
Germany	Investigational Drug	MFDS-O-CT	Death/LT SUSAR	7	Primary Reporter Country <> South Korea Report Type = Sponsored Trial
Germany	Investigational Drug	MFDS-O-CT	SUSAR MFDS Clinical Trial rule	15	Primary Reporter Country <> South Korea Report Type = Sponsored 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 = Spontaneous Clinical Trial Observe Study Type = Other Studies