Construction And Application Of MAH Pharmacovigilance Evaluation Index System

Objective: In order to improve the level of pharmacovigilance work of the drug Marketing Authorization Holder(MAH)in China,this study explores the construction of a set of evaluation index system for helping MAH to evaluate the development of pharmacovigilance work,as a guiding tool for MAH to carry out internal review of pharmacovigilance and improve the company’s pharmacovigilance work.Methods: Firstly,through literature analysis and systematic review of laws and regulations related to pharmacovigilance in China,the pharmacovigilance evaluation indicators of MAH were screened and the evaluation index system was preliminarily constructed.Secondly,experts in the field of pharmacovigilance from the drug regulatory authorities,universities,and MAHs were invited to determine the final evaluation index system and the weight of each index by using Delphi expert consultation method.Finally,the evaluation index system was applied and tested in the sample enterprises,namely,the evaluation index system was transformed into a MAH-oriented questionnaire,and the corresponding evaluation criteria and evaluation model were established to evaluate the current status of MAH’s pharmacovigilance work,so as to test the practicability and operability of the evaluation index system.Results: The final evaluation index system includes 3 first-level indicators,9 second-level indicators,and 28 third-level indicators.Among them,the weight of the result indicator is 0.350,the weight of the process indicator is 0.345,and the weight of the structure indicator is 0.305.We applied the constructed MAH pharmacovigilance evaluation index system to practice,and evaluated the current status of pharmacovigilance work in 63 sample companies of different sizes.The results show that the pharmacovigilance work of MAHs involved in this survey has some shortcomings and deficiencies,such as pharmacovigilance risk management is relatively lacking,and the overall pharmacovigilance work capacity of small and micro enterprises is relatively weak and has large room for improvement.Conclusion: On the whole,the evaluation index system constructed in this study has good scientificity,practicability and operability.Whether it is used for MAHs as an internal audit tool or the drug regulatory agencies as a regulatory tool or scholars as a research tool,it can reflect the current status of MAH’s pharmacovigilance work,and help to find the shortcomings of pharmacovigilance work.However,there are still some shortcomings in this research that need further research and improvement.For example,the number of experts in different fields should be expanded to improve the representativeness of experts.The number of enterprises applying the evaluation index system should be increased to improve the scope of its application verification,so as to further strengthen the universality of the research conclusions.