关键词: font-size:medium, ">药品上市许可持有人；药物警戒；外部报告, 递交质量管理

Abstract: Regulations for Drug Annual Report requires the marketing authorization holder (MAH) to implement the main responsibility for drug annual reports.It is an important responsibility for the MAH to submit the external pharmacovigilance report for compliance management， which can be used as the reference material and scientific judgment for drug inspection， risk assessment， credit supervision and other work， and also can be used as the evaluation indicator of local adverse drug reaction(ADR) monitoring capacity. Based on overview of the drug annual reports， individual case safety reports (ICSR)， and periodic safety update reports (PSUR) in MAH pharmacovigilance system， this study analyzed the relevant institutional regulations， organizational framework about submission compliance management of MAH pharmacovigilance external reports， and the whole life cycle pharmacovigilance system. Then the policy recommendations of pharmacovigilance external reports quality systems were put forward， such as the pharmacovigilance capacity evaluation indicators， pharmacovigilance quality authorized persons system， increasing pharmacovigilance knowledge training， and integrating into digital transformation.

Key words: Marketing authorization holder (MAH), Pharmacovigilance, External report;Submission quality management