2025 Volume 79 Issue 2 Pages 81-97
ISO/TC249 is the 249th Technical Committee (TC) established in 2009 in the International Organization for Standardization (ISO) to develop international standards for Traditional Chinese medicine (herbal medicines, acupuncture/moxibustion, and their terminology). Although the title of the TC is Traditional Chinese Medicine, it also includes Japanese Kampo medicines and Korean traditional medicine. For herbal medicines, standards are to be developed as pharmaceuticals, and health foods and supplements are excluded even if they use the same herbal materials. In addition, standards are not to be developed for individual herbal products. Over 100 international standards have already been developed, but more than half of them are related to herbal medicines/herbal products. ISO standards are voluntary standards for international trade. In herbal medicines which are pharmaceuticals, national standards such as pharmacopoeia standards already exist in several countries/regions, so international standards that encompass these standards are to be developed, and the developed standards rarely affect countries that already have domestic standards. In Japan, the Japan Liaison of Oriental Medicine (JLOM) is the mirror committee for TC249, and standards related to herbal medicines are developed through cooperation among manufacturers of herbal medicines, national institutes, and academia.