药品重点监测中省级药品不良反应监测中心的职责探讨  

Discussion on the Responsibility of Provincial Center for ADR Monitoring during Key Drug Monitoring

作　　者：孙骏[1] 魏臻[2] 李明[1] 于丹丹[1] 

机构地区：[1]江苏省药品不良反应监测中心,江苏南京210002 [2]江苏省药学会,江苏南京210002

出　　处：《中国药物警戒》2015年第9期538-541,共4页Chinese Journal of Pharmacovigilance

摘　　要：目的探讨省级药品不良反应监中心在重点监测工作中的职责。方法检索我国、美国FDA和欧盟EMA的官方网站及相关文献,并汇总分析。结果我国现阶段重点监测的目的、方法与FDA《药物警戒管理规范和药物流行病学评估》、EMA的《许可后安全性研究》基本相同,可以借鉴上述文件对管理部门的职责规定设定省级药品不良反应监测中心职责。结论省级药品不良反应监测中心是药品重点监测的技术指导单位而非合同研究组织,经授权接受重点监测方案的备案而非行政审批,监督重点监测是否按方案实施而非监查或稽查,对重点监测方案及总结报告审核但不提供最终结论。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

关 键 词：药品重点监测 省级药品不良反应监测中心 职责 

分 类 号：R951[医药卫生—药学]