Good manufacturing practice (GMP) regulation of herbal medicine in comparative research: China GMP, cGMP, WHO-GMP, PIC/S and EU-GMP

IntroductionHerbal products are widely used worldwide. In the context of globalization, quality control of these products has become an increasingly important issue not only for the consumers but also for regulators and manufacturers. Laws, regulations and guidelines stipulating requirements of good manufacturing practice (GMP) of herbal products differ worldwide and harmonization is yet to be achieved. This paper aims to study five of the major GMP regulations for herbal products adopted in different countries and regions and determine the differences in terms of principles, contents, supervision, and industrial influence.MethodsThe GMP standard selected for this study include the WHO-GMP, GMP in China, cGMP in the United States (US), Pharmaceutical Inspection Co-operation Scheme (PIC/S) in Singapore and GMP in the European Union (EU). For this purpose, government websites, national statistics, and authoritative papers from each country were fully searched.ResultsThe five GMPs were found to have major differences in the scope of products and the implementation mode. GMP of herbal products in China was developed based on the WHO-GMP. EU-GMP mirrored the PIC/S, while cGMP of dietary supplements in the US faces with multiple challenges.ConclusionsWhile these GMPs underwent parallel development toward a more comprehensive approach of quality and risk management of the entire manufacturing process, levels of implementation and enforcement critically determine the influence of the regulations and thus the quality of the products and the development of the industry.This article belongs to the Special Issue: T & G Health Issue.