Navigating the Global Terrain: Evaluation of Traditional Medicine and Regulatory Frameworks

Abstract

The global resurgence of herbal medicine underscores a paradigm shift in healthcare and regulatory landscapes, with market projections reaching USD 160.6 billion by 2030. Despite widespread cultural acceptance and rising demand, significant disparities persist across national and regional pharmacopoeias in defining quality, safety, and efficacy benchmarks for herbal products. This review systematically examines the regulatory frameworks and pharmacopoeial monographs of key global players—including WHO, USP, Ph. Eur., API, and others—with a focus on standardisation challenges. A comparative case study on Valeriana species reveals divergent approaches to botanical identity, assay thresholds, contaminant limits, and therapeutic framing, highlighting gaps between traditional and modern standards. The analysis emphasises the urgent need for harmonisation, integrating validated analytical methods, safety protocols, and region-specific ethnopharmacological knowledge. Furthermore, the evolving landscape of national policies and WHO strategies from 1999 to 2018 reflects increasing institutional efforts toward formalising traditional medicine systems. The paper advocates for unified, evidence-based herbal monograph frameworks that reconcile scientific rigour with traditional practices, thereby enabling global acceptance and regulatory coherence for herbal medicinal products.