关键词: 省市, 药品不良反应, 药物警戒, 监测评价, 责任体系

Abstract:

 The construction and development plan of the monitoring and evaluation technology system for adverse drug reaction （ADR） between the province and town， is not only related to the national pharmacovigilance system and capacity building， which is but also an important guarantee for establishing and improving the national drug alert system and enhancing the technical support capacity of local drug supervision. The construction of ADR monitoring and evaluation technology system at provincial and municipal levels is not only a top-down assessment work， but also a service awareness of serving the public and strategies for improving the monitoring and evaluation capacity of grass-roots work. In order to help enhance the technical support capacity of local drug regulation， promote the digitized transformation and improving the monitoring and evaluation capacity of grass-roots supervision，based on the status analysis of ADR monitoring and evaluation technology system construction between the province and municipality， and the status of ADR monitoring reports in hospitals， the study discussed the system foundation and development status of local ADR capacity building， authority division setting between the province and city， and the allocation of regulatory human resource. Then the study proposed the construction framework and the construction path of ADR monitoring and evaluation technology systems between the province and municipality. The indicators of the provincial ADR monitoring and evaluation technology system included the post market monitoring， safety evaluation， pharmacovigilance （GVP） verification， and the regulatory decision support. The indicators of the municipality ADR monitoring and evaluation technology system included the drug safety responsibility system and ADR monitoring and evaluation. The construction path of ADR monitoring and evaluation technology system between the province and municipality included the implementing drug safety responsibilities， promoting digital application scenarios， optimizing business environment goals， and so on.

Key words:  , Province and municipality； , Adverse drug reaction； , Pharmacovigilance； , Monitoring and evaluating； , Responsibility system