Development and Status of Pharmacovigilance Data Sharing and Data Exchange in China
China has defined the establishment of pharmacovigilance system,and established the legislative purpose of "rirk manage-ment,whole process control and social co-governance" was established. It was needed to build a working pattern of the one body and two wings,which the ADR monitoring institutions are professional technical institutions,the marketing authorization holders (MAH) and medical institutions to perform relevant responsibilities. The framework of pharmacovigilance data sharing and data exchange,including drug whole life cycle and data stream management,also includes the needs of surveillance agencies,medical institutions,disease control agencies,third-party platforms,MAH and retail pharmacies. Based on the fact that the data related to pharmacovigilance are scattered in disease control institutions,third-party platforms,medical institutions,MAH and other units,it is necessary to strengthen the sharing and exchange of pharmacovigilance data among the responsible parties,each links and fields. This study reviewed the system of pharma-covigilance data management and the current situation of pharmacovigilance data sharing and data exchange in China,explored the institu-tional design and construction principles of pharmacovigilance data sharing and data exchange. The construction path of pharmacovigi-lance data sharing and data exchange was proposed,including the goal of "Three Medicine Linkage" reform,data flow management,digi-tal application scenario,and the compilation of industry standards and guidelines,and so on. This study considered that digital applica-tion scenarios and digital governance under the framework of pharmacovigilance data sharing and data exchange are implemented through the design of pharmacovigilance data sharing and data exchange framwork involving multiple organizations,which can further promote the construction process of drug safety smart supervision.
万方数据
维普
