From Sichuan to the World: ISO Standards in Quality Control and International Trade of Chinese Herbal Medicine Chuan Xiong

Abstract: This study examines Chuan Xiong (川芎Rhizoma Chuanxiong), a traditional Chinese medicinal herb cultivated in Sichuan province, China. By systematically investigating its botanical origin, cultivation history, and international trade dynamics, the study identifies a sharp decline in global exports—once peaking at approximately 10,000 tons—and evaluates the impact of divergent pharmacopoeial standards, particularly the 2017 requirements of the European Pharmacopoeia , on trade performance. Through a historical literature review and a comparative analysis of pharmacopoeial standards across different countries and regions, the research confirms the Sichuan-specific origin and cultivation heritage of Chuan Xiong , and reveals inconsistencies in key quality control parameters, including botanical identification, macroscopic characteristics, moisture limits, and bioactive constituents. Through iterative negotiations and scientific consultations among relevant stakeholders, an international consensus was achieved, resulting in the development of a harmonized, evidence-based quality framework which was subsequently adopted as an ISO standard under ISO/TC 249. This internationally aligned standard addresses previous discrepancies in both parameter selection and specification limits, more accurately reflecting the distinctive quality profile of Chuan Xiong . The establishment of this ISO standard provides a scientifically robust and globally recognized basis for quality control, and is expected to support the recovery of exports and facilitate the integration of Chuan Xiong into international markets. Ultimately, this initiative provides a replicable model for the global harmonization of quality standards for traditional medicinal botanicals.