建立跨专业领域药物警戒体系的思考

Thoughts on Establishment of Trans-disciplinary Pharmacovigilance System

近年来,我国通过药品审评审批制度改革,加快临床急需、罕见病治疗和创新药物上市审评审批,大大满足了我国患者对于创新治疗药物可及性的需求,同时也给我国的药品安全风险监测工作带来了巨大挑战。2018年66号公告对于药品上市许可持有人(持有人)的药品不良反应报告和监测工作提出了明确和具体的要求。持有人的药物警戒工作面临着由过去仅注重对个例报告收集与分析,到对药品进行全面系统安全性评价和风险管理的转变。药物警戒科学是一门跨专业学科,因此需要持有人有效地整合公司内部和外部的资源,构建密切合作、多方参与的药物警戒工作网络,以更好地进行药品安全风险监测和评估,履行持有人的法律责任,保障患者用药安全。

In recent years,NMPA has accelerated the approval of drugs that are urgently needed and those for rare diseases and innovative treatment by reforming the drug review and approval system.This has gone a long way towards meeting the needs of Chinese patients for innovative drugs.At the same time,serious challenges are posed to drug safety risk monitoring in China.In 2018,NMPA issued a notice(No.66)to enforce the legal responsibility of Marketing Authorization Holders(MAH)for reporting and monitoring of adverse drug reactions(ADR).Thus,pharmacovigilance by MAHs should be switched from the collection and analysis of individual cases to comprehensive and systematic safety evaluation and risk management of drugs.Pharmacovigilance is a trans-disciplinary science,compelling MAHs to effectively integrate the internal and external resources of the company and build a closely cooperative and coalition network of pharmacovigilance in order to better monitor and assess drug safety risks,fulfill the legal responsibility of the holders,and ensure the drug safety of patients.