关键词: 药品重点监测, 省级药品不良反应监测中心, 职责

Abstract: Objective To discuss the responsibility of provincial center for ADR monitoring during key drug monitoring. Methods The data from official website of FDA, EMA and our country, and the related literatures are collected and analyzed. Results The purpose and method of key drug monitoring at the present stage in China are similar to the Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment of FDA, and the Guideline on Good Pharmacovigilance Practices (GVP) Module VIII-Post-Authorisation Safety studies of EMA, we may design the responsibility of provincial center for ADR monitoring during key drug monitoring referring to the above document. Conclusion Provincial center is a technical center rather than a contract research organization, be authorized to keep the study protocol of key drug monitoring on record rather than approval, supervise the implementation of key drug monitoring program rather than monitor or audit, check the study protocol and the final study report rather than provide a final conclusion

Key words: key drug monitoring, centre for adverse drug reaction at provincial level, responsibilities