Boehringer Ingelheim, Ingelheim, Germany.
AstraZeneca PLC, Cambridge, UK.
Drug Saf. 2021 Jan;44(1):17-28. doi: 10.1007/s40264-020-01008-0. Epub 2020 Dec 8.
Pharmaceutical legislation provides a legal framework to ensure the safe and effective use of medicines. This framework requires national regulatory authorities (NRAs) to establish and maintain a pharmacovigilance system (PV system) stating and enforcing the regulatory commitments that key stakeholders, including marketing authorisation holders (MAHs), are required to fulfil. In recent years, national legislative bodies and NRAs across the world have issued a significant amount of legislation and guidance enforcing the obligation to perform pharmacovigilance activities. In countries where the NRA is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), safety management requirements are generally consistent with ICH guidelines. In a number of countries beyond this scope, requirements may deviate from internationally agreed standards, adding a substantial complexity and increasing burden on the stakeholders involved, whilst the benefit for patients' safety may not be evident. Committed to fulfilling safety-regulatory obligations in any country where a product licence is held, global pharmaceutical companies have accumulated a broad and deep experience acquired whilst meeting the expectations of a large array of diverse PV systems across the world. These range from sub-optimal frameworks, according to the World Health Organization (WHO) Global Benchmarking Tool, to highly effective resource-optimised PV systems. In order to support countries creating or further developing their PV systems, especially where infrastructure and resources are limited, the European Federation of Pharmaceutical Industries and Associations (EFPIA) International Pharmacovigilance Group (IPVG) has developed consensus recommendations consistent with harmonised standards for the development and step-wise implementation of key PV system components. These recommendations endorsed by the EFPIA membership constitute the focus of this review article.
药品立法为确保药品的安全和有效使用提供了法律框架。该框架要求国家监管机构（NRA）建立和维护一个药物警戒系统（PV 系统），阐明和执行包括上市许可持有人（MAH）在内的主要利益相关者必须履行的监管承诺。近年来，世界各国的国家立法机构和 NRA 发布了大量立法和指南，要求履行药物警戒活动的义务。在 NRA 是国际人用药品注册技术协调会（ICH）成员的国家，安全管理要求通常与 ICH 指南一致。在这些范围之外的一些国家，要求可能与国际商定的标准存在偏差，这给相关利益相关者增加了大量的复杂性和负担，而对患者安全的益处可能并不明显。为了履行在任何持有产品许可证的国家的安全监管义务，全球制药公司积累了广泛而深入的经验，这些经验是在满足全球各种不同的 PV 系统的期望的基础上获得的。这些系统从世界卫生组织（WHO）全球基准工具认为的次优框架，到高度有效的资源优化的 PV 系统都有。为了支持各国建立或进一步发展其 PV 系统，特别是在基础设施和资源有限的情况下，欧洲药品工业协会联合会（EFPIA）国际药物警戒小组（IPVG）制定了与协调标准一致的共识建议，用于开发和逐步实施关键 PV 系统组件。EFPIA 成员认可的这些建议构成了本文综述的重点。
