Preliminary Construction of the Pharmacovigilance and Adverse Drug Reaction Relief System under the D-MAH system

Objective: China plans to establish a system for designated marketing authorization holders (D-MAH) for overseas drugs to regulate their lifecycle in China. Methods: This article analyzes domestic MAH/D-MAH, pharmacovigilance (PV), and drug damage relief systems, and compares PV and drug damage relief systems in the US, Japan, South Korea, and Taiwan. Results: D-MAH must have the qualifications and ability to establish a PV system. Its drug vigilance system should be assessed based on responsibility-bearing ability, ADR awareness, and clinical trial PV system building. Conclusion: Clinical trial drug damage should be compensated through compulsory insurance, while general medication damage through a fund model.