欧盟药品上市后安全性研究监管体系分析与思考

效益风险评估贯穿于药品整个的生命周期。为保障药品全生命周期最佳效益风险比，识别并针对药品风险因素采取适宜的风险最小化措施，积极开展药品上市后安全性研究尤为重要。欧洲药品管理局（European Medicines Agency，EMA）为了量化药品的安全隐患，基于评估药物的效益风险状况并支持监管决策而开展上市后安全性研究（postauthorisation safety study，PASS），为保障其顺利开展而形成一套成熟的体系及监管流程。通过分析EMA开展PASS的制度及流程，提出建立健全监管体系、制定PASS指南及实施细则以及建立共享平台是丰富完善我国上市后安全评价体系的有效方式。

Analysis of regulatory system of post-authorization safety studies in European Union and its enlightenment for China

Benefit-risk assessment runs through the whole life cycle of drug development and marketing. To optimize the balance of benefits and risks during the life cycle, it is important to conduct a post-authorisation safety studies (PASS) once a drug is launched, to identify the real-life risk factors of such drugs, and then take appropriate risk minimization measures. In order to better define the benefits and risks of drugs, the European Medicines Agency (EMA) introduced the PASS policy, the aims of which were to identify, characterize or quantify a safety hazard, confirm the safety profile, or the effectiveness of risk management measures. EMA had produced a set of mature regulatory processes to help PASS be conducted successfully. In this paper, we systematically introduced and analyzed PASS regulation system in EMA, and put forward effective ways to improve the drug safety administration system in China, like creating regulatory PASS guidelines and implementation rules, as well as establishing a public platform for all PASS in China.