Sethi Sumeet Singh, Bhardwaj Tejaswani, Sethi Surjeet Kaur, Kaur Sukhpreet, Baldi Ashish
Pharma Innovation Lab, Department of Pharmaceutical Sciences & Technology, Maharaja Ranjit Singh Punjab Technical University, Bathinda, Punjab, 151001, India.
Dasmesh College of Pharmacy, Faridkot, Punjab, India.
Naunyn Schmiedebergs Arch Pharmacol. 2025 May 8. doi: 10.1007/s00210-025-04066-2.
Herbal and traditional medicines (H&TMs) form a significant part of healthcare practices worldwide, often perceived as safe alternatives to conventional treatments. However, this perception has led to challenges in ensuring the safety and efficacy of these products, highlighting the critical importance of pharmacovigilance for herbal medicines. Over the past two decades, concerted efforts have been made globally to establish robust regulatory frameworks, leading to the emergence of phytovigilance systems. This review provides a comprehensive overview of the pharmacovigilance mechanisms in various countries, emphasizing recent developments, persistent challenges, and international perspectives in the field. The study underscores the need for systematic monitoring of adverse events (AEs) associated with herbal medicines to safeguard patient health. A key focus is placed on comparing the processes and mechanisms employed by different nations in building up safety monitoring systems, identifying gaps in knowledge and practices, and evaluating stakeholder awareness and involvement. The findings highlight the necessity of harmonizing global regulations under the guidance of the World Health Organization (WHO) to ensure uniformity and efficacy in reporting systems. This article advocates for a collaborative international approach, inclusive of all regulatory agencies, to enhance the safety of herbal therapies. By proposing comprehensive, standardized guidelines, it aims to bridge existing gaps and strengthen the pharmacovigilance infrastructure for herbal medicines globally, paving the way for improved patient safety and trust in traditional medical practices.
草药和传统药物构成了全球医疗实践的重要组成部分，通常被视为传统治疗的安全替代方案。然而，这种认知给确保这些产品的安全性和有效性带来了挑战，凸显了草药药物警戒的至关重要性。在过去二十年里，全球共同努力建立强大的监管框架，催生了植物药警戒系统。本综述全面概述了各国的药物警戒机制，强调了该领域的最新进展、持续存在的挑战以及国际视角。该研究强调需要对与草药相关的不良事件进行系统监测，以保障患者健康。重点在于比较不同国家在建立安全监测系统时所采用的流程和机制，找出知识和实践方面的差距，并评估利益相关者的意识和参与度。研究结果凸显了在世界卫生组织（WHO）的指导下协调全球法规的必要性，以确保报告系统的一致性和有效性。本文倡导一种包括所有监管机构的国际协作方法，以提高草药疗法的安全性。通过提出全面、标准化的指南，旨在弥合现有差距，加强全球草药药物警戒基础设施，为提高患者安全性和增强对传统医疗实践的信任铺平道路。
