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高收入国家的药物警戒:当前发展与文献综述

Pharmacovigilance in High-Income Countries: Current Developments and a Review of Literature.

作者信息

Khan Muhammad Akhtar Abbas, Hamid Saima, Babar Zaheer-Ud-Din

机构信息

Health Services Academy Islamabad, Chak Shahzad, Islamabad 44000, Pakistan.

Fatima Jinnah Women University, Rawalpindi 46000, Pakistan.

出版信息

Pharmacy (Basel). 2023 Jan 6;11(1):10. doi: 10.3390/pharmacy11010010.

Abstract

The world bank has classified 80 economies based on their Gross National Income (GNI) per capita as High-Income. European Medicines Agency (EMA), Food and Drug Administration (FDA), and Pharmaceuticals and Medical Devices Agency (PMDA) are the major regulatory stakeholders driving global pharmacovigilance regulations. The purpose of this article is to describe pharmacovigilance systems and processes in high-income countries, particularly those that are also members of the International Conference on Harmonization (ICH). All high-income countries are members of the WHO PIDM. The income level of a country has a direct relationship with medicine safety measures. All ten pioneering members of the Uppsala monitoring centre are from high-income countries and were the first responders after the thalidomide tragedy by making drug evaluation committees, introducing the ADR reporting forms and taking safety measures. Despite access to the VigiBase, some countries have separate databases for managing and analyzing data like Canada Vigilance online database, FDA Adverse Event Reporting System, the French pharmacovigilance database and European Union's system Eudravigilance. All high-income countries have robust pharmacovigilance systems. USFDA and EMA are the world leaders in the field of pharmacovigilance. Most high-income countries follow EMA guidelines. Medicine safety is directly influenced by a country's income level.

摘要

世界银行根据人均国民总收入(GNI)将80个经济体归类为高收入国家。欧洲药品管理局(EMA)、美国食品药品监督管理局(FDA)和日本药品和医疗器械管理局(PMDA)是推动全球药物警戒法规的主要监管利益相关者。本文旨在描述高收入国家的药物警戒系统和流程,特别是那些也是国际协调会议(ICH)成员的国家。所有高收入国家都是世界卫生组织药物不良反应监测规划(WHO PIDM)的成员。一个国家的收入水平与药品安全措施直接相关。乌普萨拉监测中心的所有十个创始成员都来自高收入国家,并且在沙利度胺悲剧发生后,通过成立药物评估委员会、引入药品不良反应报告表和采取安全措施,成为了第一批响应者。尽管可以使用VigiBase,但一些国家有单独的数据库用于管理和分析数据,如加拿大警戒在线数据库、FDA不良事件报告系统、法国药物警戒数据库和欧盟的Eudravigilance系统。所有高收入国家都有强大的药物警戒系统。美国食品药品监督管理局(USFDA)和欧洲药品管理局(EMA)是药物警戒领域的全球领导者。大多数高收入国家遵循EMA指南。药品安全直接受到一个国家收入水平的影响。

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