Tsutani Kiichiro, Takuma Hiroki
Department of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.
Yakugaku Zasshi. 2008 Jun;128(6):867-80. doi: 10.1248/yakushi.128.867.
Regulatory science began in the late 1980's in the pharmaceutical area in Japan. It aimed not only at vertical, top-down regulation but also horizontal regulation to suit the social value system. Herbal medicines and dietary supplements are two areas where regulatory science is still not well developed and used. Risk perception, risk assessment and risk management in these areas are often neglected by regulators, academicians and the public. Since the risk of using herbal medicines and dietary supplements is a global concern, development of a global regulatory system is needed. In this paper, we introduce the current situation of several projects which deal with regulatory science in herbal medicines and dietary supplements, namely: (1) Herbal ATC (HATC) classification project initiated by Uppsala Monitoring Centre (UMC) which led to the development of the provisional HATC code of 228 Kampo formulae and Standard Kampo Formula Nomenclature (SKFN) in Japan, (2) WHO/WPRO International Standardization of Terminology (IST) which resulted in the publication of "WHO Internal Standard Terminologies on Traditional Medicine in the Western Pacific Region Forum for Herbal Harmonization", (3) Forum for the Harmonization of Herbal Medicines (FHH), (4) CONSORT extension for herbal medicines, (5) ICH M5 (Data elements and standards for drug dictionaries), and (6) activities on nomenclature at the International Organization for Standardization (ISO). However, there is a lack of coordination among these projects. Therefore, harmonization of all projects aimed at harmonizing and standardizing all aspects of regulatory science for herbal medicines and dietary supplements is recommended. However, careful consideration should be given to each unique local situation.
监管科学始于20世纪80年代末的日本制药领域。它不仅旨在进行纵向的、自上而下的监管，还致力于符合社会价值体系的横向监管。草药和膳食补充剂是监管科学仍未得到充分发展和应用的两个领域。监管机构、学者和公众往往忽视了这些领域的风险认知、风险评估和风险管理。由于使用草药和膳食补充剂的风险是一个全球关注的问题，因此需要建立一个全球监管体系。在本文中，我们介绍了几个涉及草药和膳食补充剂监管科学的项目的现状，即：（1）由乌普萨拉监测中心（UMC）发起的草药解剖学治疗学化学分类（HATC）项目，该项目促成了日本228种汉方制剂临时HATC代码和标准汉方制剂命名法（SKFN）的制定；（2）世界卫生组织/西太平洋区域办事处国际术语标准化（IST）项目，该项目促成了《西太平洋区域草药协调论坛传统医学世卫组织内部标准术语》的出版；（3）草药协调论坛（FHH）；（4）草药 CONSORT 扩展版；（5）国际人用药品注册技术协调会M5（药品词典的数据元素和标准）；以及（6）国际标准化组织（ISO）在命名方面的活动。然而，这些项目之间缺乏协调。因此，建议对旨在协调和规范草药和膳食补充剂监管科学各个方面的所有项目进行协调。不过，对于每个独特的当地情况都应予以仔细考虑。
