Evaluation index system of MAH pharmacovigilance work

doi:10.19803/j.1672-8629.20230508

Abstract

Abstract: Objective To explore methods to quantitatively evaluate the pharmacovigilance evaluation work of marketing authorization holder(MAH) and support the development of scientific supervision work based on big data. Methods The analytic hierarchy process(AHP) method was used to decompose and detail ADR/ADE monitoring and reporting, risk identification and evaluation, post-market safety research, drug safety risk control and other related aspects, forming the MAH pharmacovigilance work evaluation index system. A data analysis information platform based on this index system was designed. Results 6 indicators of the criterion layer, 25 indicators of the sub-criterion layer and 85 indicators of the lowest layer are selected, and the weight values of each indicator of the evaluation system are determined. Based on the actual business situation and real world data, an information platform for MAH pharmacovigilance work evaluation was explored and designed. Conclusion The evaluation index system and information platform of holder pharmacovigilance laid the foundation for the intelligent evaluation of MAH pharmacovigilance work.

Key words: analytic hierarchy process(AHP), marketing authorization holder(MAH), pharmacovigilance, evaluation index, information platform, adverse drug reaction

CLC Number:

R954

JIA Jinsheng, WANG Qing, LIU Hongliang, HOU Yongfang. Evaluation index system of MAH pharmacovigilance work[J]. Chinese Journal of Pharmacovigilance, 2023, 20(10): 1090-1094.

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