关键词: 药物警戒, 数据共享, 数据交换, 医疗机构, 数据流

Abstract:

 China has defined the establishment of pharmacovigilance system， and established the legislative purpose of “rirk management， 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 pharmacovigilance data management and the current situation of pharmacovigilance data sharing and data exchange in China，explored the institutional design and construction principles of pharmacovigilance data sharing and data exchange. The construction path of pharmacovigilance data sharing and data exchange was proposed， including the goal of "Three Medicine Linkage" reform， data flow management， digital application scenario， and the compilation of industry standards and guidelines， and so on. This study considered that digital application 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.

Key words: Pharmacovigilance； , Data share； , Data exchange； , Medical institution； , Data flow