RESUMO
OBJECTIVE To provide policy referen ce for local marketing authorization holder （MAH）to implement their main responsibility of drug life cycle supervision and the Guiding Principles of Pharmacovigilance Inspection to be officially released. METHODS Taking 15 MAH in Shanghai who recently underwent pharmacovigilance inspection as the research objects ，the social network analysis was used to explore the logical relationship between MAHs ’enterprise attributes and inspection problems ， summarize the problems found ，analyze the causes ，and put forward corresponding countermeasures. RESULTS & CONCLUSIONS The problems found in this pharmacovigilance inspection were mainly in aspects of organization ，personnel management ，quality management system ，report quality and so on. The reasons for these problems included light punishment ，which lead to the enterprise management ’s lack of attention to the pharmacovigilance system ，unclear problem handling and risk control mechanism ， imperfect quality management system documents ，inadequate personnel training ，etc. MAH needs to pay more attention to pharmacovigilance，allocate corresponding human and resources ，constantly improve the pharmacovigilance quality management system，and improve the enforceability and effectiveness of the pharmacovigilance system. At the same time ，it is suggested that government departments should strengthen policy guidance ， publicity and implementation ， and combine with third-party institutional platforms such as industry associations to promote the smooth implementation of Good Validation Practice .