ISO/TC 249 platform promotes the development of international standardization and trade for the Chinese medicines industry

Abstract

The trade of Chinese medicines (CMs) has developed rapidly worldwide. There is an urgent need for international standards of CMs in international trade. A newly established technical committee TC249 in the International Organization for Standardization (ISO) provides a platform for developing the international standards of traditional Chinese medicine. This article introduces the overview and development strategy of the international standardization of CMs. A quality assurance system for the entire industrial chain was well designed in the fields of seedlings, medicinal materials, and manufactured products. The general standards, testing method standards, and standards for single herbal medicines meet the urgent needs of the market and should be developed with high priority to promote the international trade of CMs and guarantee the quality and safety of clinical use. This article also introduces the significance, classification, and procedures for developing international standards of CMs and helps us better understand the international standardization work of CMs.

Keywords: Chinese medicines; ISO/TC249; International standard; Quality assurance system; Standardization.