1. China NMPA E2B(R3) Best Practices
  2. Reporting rules setup

4 Reporting rules setup

Each report to NMPA has to be routed to the CDE/CDR Receiver Identifier depending on the case data, such as: Report Type, Primary Reporter Country and Observe Study Type.

Note:

Reporting rules should be set up in Argus with advanced conditions.

The below table displays some sample reporting rules.

Country License type Agency Rule name Timeframe calendar days Advanced condition
China Marketed Drug CDR Death/LT ADR Domestic 7 Primary Reporter Country = China Report Type = Spontaneous
China Marketed Drug CDR Serious ADR Domestic 15 Primary Reporter Country = China Report Type = Sponsored Trial Observe Study Type = Individual Patient Use or Other Studies
United States Marketed Drug CDR Death/LT Foreign 7 Primary Reporter Country <> China Report Type = Spontaneous
United States Marketed Drug CDR Serious ADR Foreign 15 Primary Reporter Country <> China Report Type = Sponsored Trial Observe Study Type = Individual Patient Use or Other Studies
China Investigational Drug CDE SUSAR CT Domestic 30 Primary Reporter Country = China Report Type = Sponsored Trial Observe Study Type = Clinical Trial
United States Investigational Drug CDE SUSAR CT Foreign 30 Primary Reporter Country <> China Report Type = Sponsored Trial Observe Study Type = Clinical Trial

The following table describes the set of criteria for the Report Category (C.1.CN.2). All mappings, validations and conformance are formed based on this criteria.

C.1.CN.2 Reporting Category Criteria
Domestic Study Case (NMPA code = 11)
  • Cases that have REPORTTYPE [C.1.3] = 2, OBSERVESTUDYTYPE [C.5.4] = 1 and REPORTERCOUNTRYR3 [C.2.r.3] for Primary Reporter = CN
Domestic Post-Market Case (NMPA code = 12)
  • Cases that have REPORTTYPE [C.1.3] = 2, OBSERVESTUDYTYPE [C.5.4] = 2 or 3 and REPORTERCOUNTRYR3 [C.2.r.3] for Primary Reporter = CN
  • Cases that have REPORTTYPE [C.1.3] <> 2 and REPORTERCOUNTRYR3 [C.2.r.3] for Primary Reporter = CN
Foreign Study Case (NMPA code = 21)
  • Cases that have REPORTTYPE [C.1.3] = 2, OBSERVESTUDYTYPE [C.5.4] = 1 and REPORTERCOUNTRYR3 [C.2.r.3] for Primary Reporter <> CN
Foreign Post-Market Case (NMPA code = 22)
  • Cases that have REPORTTYPE [C.1.3] = 2, OBSERVESTUDYTYPE [C.5.4] = 2 or 3 AND REPORTERCOUNTRYR3 [C.2.r.3] for Primary Reporter <> CN
  • Cases that have REPORTTYPE [C.1.3] <> 2 and REPORTERCOUNTRYR3 [C.2.r.3] for Primary Reporter <> CN