Advancing herbal medicine safety: the need for a global pharmacovigilance approach

Abstract

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.

Keywords: Adverse effect; Herbal drugs; Pharmacovigilance; Phytovigilance; Regulatory guidelines; Traditional medicines.