Analysis of Risk Factors of MAH Pharmacovigilance Outsourcing / 中国药房

ABSTRACT

OBJECTIVE：To analyze th e risk factors of marketing authorization holder （MAH）pharmacovigilance outsourcing and propose risk management and control strategies ， and to provide reference for MAH to successfully implement pharmacovigilance outsourcing and regulatory authorities to formulate corresponding regulatory strategies. METHODS ：Based on the principal-agent theory and brainstorming method ，the risk factors were preliminarily determined ，and a questionnaire was designed. The questionnaire survey was carried out among pharmacovigilance staff of 200 MAH in Guangdong province by random sampling. The factor analysis method was used to statistically analyze the questionnaire data ，and the comprehensive risk factors and their respective factor scores were summarized. RESULTS & CONCLUSIONS ：A total of 200 questionnaires were distributed ， and 154 valid questionnaires were returned ，with effective recovery rate of 77.00％. The results of factor analysis method showed that there were 4 comprehensive risk factors involved in MAH pharmacovigilance outsourcing activities ，which were service providers and outsourcing management factor （3.792 score），MAH factor （3.766 score），regulations factor （3.626 score）and market factor （3.610 score）from high to low. In view of the above factors ，it is suggested that MAH should focus on improving outsourcing contract ，establishing information communication mechanism with service providers ，strengthening auditing and management，strengthening pharmacovigilance ability and personnel building ，defining appropriate pharmacovigilance outsourcing business contents ， and fully doing pre-service investigation of service providers ， when MAH conducts outsourcing of pharmacovigilance. It is suggested that relevant departments should formulate pharmacovigilance entrusted quality management specifications or guidelines as soon as possible and strengthen the supervision of service providers. It is suggested to try to establish a pharmacovigilance outsourcing industry associa tion， andstandardize the industry behavior by giving full play to the influence of the association ，so as to avoid the outsourcing risk.