Configure expedited rules

Make sure to enter the following information in the reporting rules created for the IND and Pre-ANDA Studies cases in addition to other reporting criteria that are configured in the expedited rules:

Rule	Country	Drug type	Message type	Study reference type
IND	United States	Investigational drug	ichicsr	CDER-IND or CBER-IND
Pre-ANDA	United States	Investigational drug	ichicsr	Pre-ANDA

No special configuration is required to create rules for the marketed drug.

If you are transitioning from MedWatch format to E2B(R3) for IND reporting to FDA, then it is recommend to modify the existing rules used for reporting to FDA by updating the report form to E2B, and configure additional information required as specified above.

Note:

If you are not transitioning from the MedWatch format to E2B(R3) for reporting to FDA, then we recommend you modify the Reporting Destination > Message Profile used for MedWatch reporting to FDA MEDWATCH 3500A DRUG TEMPLATE.