Standards of Herbal Materials and Herbal Products Developed by International Organization for Standard (ISO/TC 249)

Abstract

The International Organization for Standardization (ISO) plays a role in the development of international standards. The standardization in the field of traditional Chinese medicine is undertaken by a technical committee known as ISO/TC 249. The committee focuses on quality and safety of raw materials, manufactured products and medical devices, informatics and service standards excluding the clinical practice or application of those products. According to the various working groups of the technical committee, the standards of herbal materials and herbal products are developed by working groups (WG) 1 and2. The objective of this article is to present the published ISO standards to promote the trade opportunities and support the international quality of herbal materials and herbal products. The published ISO standards contain the standards of certain herbal materials which are commercially available in Thailand, e.g. Ling Zhi and Japanese honey suckle, some of which are extensively used as the ingredients of Thai herbal preparations, i.e. ginger and rhubarb. The standards of testing methods are also published in order to assure quality and safety of herbal products. However, many standards of other herbal materials and testing methods are still under development. In comparison to the International Pharmacopoeia, the similarity of specifications is observed. The standards of ISO/TC 249 are approved by the committee from various countries which differs from the process of development of the particular Pharmacopoeia. The standards of ISO/TC 249 are consequently suitable for international trade. Therefore, the quality control of the raw materials and herbal products by referencing the ISO standards should be considered.