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.
ABSTRACT
OBJECTIVE：To provide assistance for the smooth implementation of classification management policies of retail pharmacies in Guangdong province and the scientific supervision of retail pharmacies by relevant departments. METHODS ：In this study，key interviews were conducted among 68 interviewees，involving experts from Guangdong drug regulatory department ，head of retail pharmacies and research experts on relevant policies of universities. The current situation ，problems and suggestions of the classification management policy of retail pharmacies in Guangdong province were summarized. RESULTS & CONCLUSIONS ： The implementation of the classification management policies for retail pharmacies in Guangdong province operated well. Drug regulatory authorities at all levels could conduct daily supervision in accordance with policy requirements. Retail pharmacies operated in strict accordance with the classification management policy and established a relatively complete quality management system. However ，there were still problems such as difficulty in policy implementation ，insufficient policy clarity ，increased regulatory pressure and regulatory risks from government regulatory agencies ，rising operating costs and increasing pressure in retail pharmacies，the large gap of licensed pharmacists ，difficult to investigate and deal with “affiliation of certificate ”behavior，and difficult survival for remote pharmacies ，and the impact on the convenience of drug use of the public. It is suggested to improve the content of the policy ，introduce related supporting measures ，strengthen the construction of the supervisory team ，increase policy publicity，improve the ways and methods to investigate and deal with the “affiliation of certificate ”behavior of licensed pharmacists， and help retail pharmacies to diversify their operations and chain operations. It is recommended that relevant government departments should further improve the content of the policy and actively adjust the supervision methods to make the policy better implemented.