Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works.
Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works.
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DOI：
10.1007/s40264-017-0572-8
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发表时间：
2017-10
期刊：
影响因子：
4.2
通讯作者：
Arlett P
中科院分区：
文献类型：
--
作者：
Santoro A;Genov G;Spooner A;Raine J;Arlett P
本文概述了欧盟药物警戒系统的合理化和加强通过实施修订后的药物警戒立法。它概述了系统的目标、基本原则、组成部分和未来变革的驱动因素。药物警戒风险评估委员会的核心是负责评估药品风险管理的各个方面，从而确保批准进入欧盟市场的药物得到最佳使用，使其获益最大化，风险最小化。该系统的主要目标是促进和保护公众健康，支持提供药品，包括满足以前未得到满足的医疗需求的药品，并减少药品不良反应的负担。这些都是通过积极主动、风险相称和以病人为中心的方法实现的，同时具有高度的透明度和民间社会的参与。在欧洲联盟，药物警戒现已完全纳入医药产品的生命周期，药物警戒活动的规划在药物投放市场之前就开始了，鼓励公司在开发高创新产品时尽早开始规划。在获得批准后，可继续通过各种来源获得药物安全性信息，包括药物不良反应的自发报告或监测真实世界数据。最后，对药物警戒活动、审计和检查以及能力建设的影响进行衡量，确保该系统不断改进，并始终依靠最佳方法来保障公共健康。
This article provides an overview of the European Union pharmacovigilance system resulting from the rationalisation and strengthening delivered through the implementation of the revised pharmacovigilance legislation. It outlines the system aims, underlying principles, components and drivers for future change. At its core, the Pharmacovigilance Risk Assessment Committee is responsible for assessing all aspects of the risk management of medicinal products, thus ensuring that medicines approved for the European Union market are optimally used by maximising their benefits and minimising risks. The main objectives of the system are to promote and protect public health by supporting the availability of medicines including those that fulfil previously unmet medical needs, and reducing the burden of adverse drug reactions. These are achieved through a proactive, risk proportionate and patient-centred approach, with high levels of transparency and engagement of civil society. In the European Union, pharmacovigilance is now fully integrated into the life cycle of medicinal products, with the planning of pharmacovigilance activities commencing before a medicine is placed on the market, and companies encouraged to start planning very early in development for high-innovation products. After authorisation, information on the safety of medicines continues to be obtained through a variety of sources, including spontaneous reports of adverse drug reactions or monitoring real-world data. Finally, the measurement of the impact of pharmacovigilance activities, auditing and inspections, as well as capacity building ensure that the system undergoes continuous improvement and can always rely on the best methodologies to safeguard public health.
影响因子：
4.2
作者：
Dal Pan, Gerald J.;Arlett, Peter R.
通讯作者：
Arlett, Peter R.