ハーブ・生薬・サプリメントのリスクのレギュラトリーサイエンス

抄録

  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.