[International coordinative development of Chinese herbal medicine standards: comparison and integration of ISO standards with mainstream national pharmacopoeias standards].

The International Organization for Standardization(ISO)/Technical Committee on Traditional Medicine(TC 249)/Subcommittee on Traditional Chinese Medicine(SC1), has long been dedicated to establishing a unified international standard system for traditional Chinese medicine(TCM), thereby promoting the high-quality development of the TCM industry through international standards. The development of ISO standards in the field of Chinese herbal medicine is among its core missions. Currently, the ISO standards for Chinese herbal medicine are playing a positive role in fostering the rapid development of its global trade and industry. However, the level of global promotion and application of ISO standards, particularly their integration and information sharing with the world's mainstream pharmacopoeias, remains in the initial exploratory stage. The primary reason for this is that the coordinated development model between ISO standards and the world's mainstream pharmacopoeias in terms of law, function, and technology is still unclear. To address this issue, this study constructed a three-dimensional comparison framework( "Law-Function-Technology"), systematically analyzed the root causes of standard disparities, and proposed a "trinity" collaborative strategy based on this analysis: from a legal perspective, bridge standard gaps through progressive integration; from a functional level, establish a dual-track quality control system that integrates ISO process management with pharmacopoeia terminal spot checks; from a technical perspective, create a collaborative mechanism for "safety-quality" classification indicators, aiming to promote technical sharing and coordinated development between ISO standards and mainstream pharmacopoeia standards.