A global comparative analysis of guidelines for herbal medicines Pharmacopoeia and Good Manufacturing Practice, with a case study of Panax ginseng C.A Meyer

Abstract

Introduction

The use of herbal medicines is widespread, and ensuring their quality control, as guaranteed by pharmacopoeia and Good Manufacturing Practice (GMP) guidelines, has garnered significant attention. Discrepancies in quality standards across different regulatory agencies challenge the global marketing of herbal medicines and hinder public access to these products. Therefore, this research aims to compare pharmacopeia on Panax ginseng C.A. Meyer (P. ginseng) and GMP guidelines for herbal medicines to provide an evidence-based understanding of quality control standards.

Methods

Definitions of herbal medicines across regulatory authorities, including the World Health Organization (WHO), Pharmaceutical Inspection Co-operation Scheme (PIC/S), European Union (EU), China, Japan, South Korea, and Vietnam, were collected. Additionally, pharmacopeial standards on Panax ginseng case study were analysed, focusing on aspects such as origin, identification, testing methods, extractives, assay, purity, and drug information. The study also compared GMP requirements for herbal medicines, which included personnel, premises and equipment, documentation, production, quality control, contract manufacturing and analysis, complaints and product recall, and self-inspection.

Results

Definitions of herbal medicines are similar among the WHO, PIC/S, and the EU, while distinct definitions based on scientific evidence and traditional practices were presented in China, Japan, South Korea, and Vietnam. Pharmacopeia standards varied across regulatory agencies, as evidenced by the P. ginseng case study. However, testing methods closely resembled each other between China and Vietnam, as well as between Japan and South Korea. Among pharmacopoeias, the WHO monographs offered the most comprehensive drug information on P. ginseng. In contrast, the European Pharmacopoeia lists such details separately in a P. ginseng assessment report. Regarding GMP requirements, although examined components varied among regulatory agencies, significant resemblances exist between the GMP guidelines of PIC/S, the EU, and South Korea, and between those of the WHO and Vietnam.

Conclusions

Disparities in quality standards across jurisdictions highlight the necessity for international collaboration to achieve harmonization. Harmonizing these standards aims to promote the global availability of standardized herbal medicinal products, benefiting public health.