Overview
ISO/TR 23975:2019 - Traditional Chinese medicine - Priority list of single herbal medicines for developing standards - is a Technical Report published by ISO in 2019. It provides a ranked reference list of single herbal medicines to guide the systematic development of international standards for Traditional Chinese Medicine (TCM) single herbs. Prepared by ISO/TC 249 (Traditional Chinese medicine), the report is informational (no normative references) and is intended as a planning tool for standards bodies, regulators and industry.
Key topics
- Purpose and scope
- Presents a priority list of single herbal medicines for standard development.
- Supports globally harmonized standards to improve consumer safety and trade.
- Principles used to set priorities
- International trade volume (example top exporters: ginseng, goji/lycium, rehmannia).
- Inclusion in pharmacopoeias (PRC, Hong Kong, Japan, Korea, Europe, USP, Thailand).
- Safety concerns, including herbs reported to cause adverse drug reactions (ADR).
- Existing ISO standards and standards under development.
- Conservation status - herbs listed under CITES are given lower priority.
- Expert consultation and statistical data analysis.
- Technical indexes and data processing
- Sections cover international trading data, pharmacopoeial occurrence, safety records, current standards status, endangered-species listings, and methods for expert consultation and data statistics.
- Deliverables
- A ranked list (main list and Annex A covering ranks 101–366) to help plan standard development timelines.
Applications
- Standards development organizations - prioritize resources to develop monograph-like standards for high-impact herbs.
- Regulators and public health agencies - identify herbs requiring urgent quality/safety standards due to ADR reports or high trade volume.
- Pharmacopoeia committees and laboratories - align testing methods and monographs internationally.
- Herbal manufacturers, exporters and importers - focus compliance and quality assurance efforts on high-priority single herbs.
- Researchers and NGOs - use the priority list for risk assessment, conservation and safety studies.
Related standards and references
- Prepared by ISO/TC 249, and cross-references multiple national and regional pharmacopoeias (PRC, HKS, JP, KP, EUP, USP, THP).
- Useful alongside WHO and national TCM guidance when harmonizing monographs, quality control methods and safety assessments.
Keywords: ISO/TR 23975:2019, Traditional Chinese medicine, single herbal medicines, priority list, international standards, pharmacopoeia, adverse drug reactions, CITES, ISO/TC 249.