欧美药物安全性信号检测——监管机构与制药企业的联动

Drug Safety Signal Detection in Europe and North America--the Cooperation between Regulatory Authorities and Pharmaceutical Enterprises

药物安全性信号检测是药物警戒(PV)工作的关键环节,是了解药物/疫苗的安全特性和风险特征的基础。长期和持续的药物安全性信号检测是确保药品安全性的关键。相较于欧美发达国家,我国的药物安全性信号检测工作起步较晚,如何准确地理解并执行药物安全性信号检测是药物警戒工作中的重点和难点。充分利用国家药品不良反应安全数据库、制药企业数据库及其他来源的相关数据展开被动监测和主动监测,是我国药物安全性信号检测当前重要和紧迫的任务。本研究梳理了药物安全性信号的定义、信号检测的数据来源、信号检测的方法和过程,并参考欧美发达国家和地区的经验,探讨监管机构和制药企业在药物安全性信号检测工作中的职责以及高效合作模式,以期为我国药品监管机构和制药企业的药物安全性信号检测工作协同落地提供借鉴和参考。建议制药企业加强与监管机构的合作和沟通,持续探索适宜的统计方法应用到现有的药品不良反应数据库中;建议监管机构和制药企业在药物安全性信号检测工作中通力合作,共同承担监测药品/疫苗安全的责任。

Drug safety signal detection is an essential activity of pharmacovigilance(PV),which is the basis for understanding the safety profiles and risk characteristics of drugs and vaccines.Long-term and continuous detection of drug safety signals is the key for ensuring the safety of medicinal products.Compared with that in Europe and North America,the work of drug safety signal detection in China started relatively late.How to accurately understand and execute drug safety signal detection is the key and difficult point in pharmacovigilance.Therefore,it is an important and urgent task to fully utilize the national adverse drug reaction safety database,pharmaceutical companies′databases,and other relevant data to carry out passive surveillance and active surveillance for drug safety signal detection in China.This study summarizes the definition of drug safety signal,and the data sources,methods and processes of signal detection.With reference to the experience of developed countries and regions in Europe and North America,the responsibilities of regulatory authorities and pharmaceutical enterprises in drug safety signal detection and efficient cooperation mode are discussed.It is recommended that pharmaceutical enterprises continue to explore appropriate statistical methods to apply to the existing ADR databases with cooperation and communication with regulatory agencies.It is recommended that regulatory authorities and pharmaceutical enterprises actively collaborate in drug safety signal detection and jointly share the responsibility for monitoring the safety of drugs/vaccines.