效益風(fēng)險(xiǎn)評(píng)估貫穿于藥品整個(gè)的生命周期。為保障藥品全生命周期最佳效益風(fēng)險(xiǎn)比，識(shí)別并針對(duì)藥品風(fēng)險(xiǎn)因素采取適宜的風(fēng)險(xiǎn)最小化措施，積極開展藥品上市后安全性研究尤為重要。歐洲藥品管理局（European Medicines Agency，EMA）為了量化藥品的安全隱患，基于評(píng)估藥物的效益風(fēng)險(xiǎn)狀況并支持監(jiān)管決策而開展上市后安全性研究（postauthorisation safety study，PASS），為保障其順利開展而形成一套成熟的體系及監(jiān)管流程。通過分析EMA開展PASS的制度及流程，提出建立健全監(jiān)管體系、制定PASS指南及實(shí)施細(xì)則以及建立共享平臺(tái)是豐富完善我國上市后安全評(píng)價(jià)體系的有效方式。

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.

R951

國家中醫(yī)藥管理局中醫(yī)藥行業(yè)科研專項(xiàng)（201507004）；國家食品藥品監(jiān)督管理總局保健食品審評(píng)中心保健食品原料目錄研究專項(xiàng)課題（ZBW-2017-BJSP-10）