Review Article

Advancing the Regulation of Traditional and Complementary Medicine Products: A Comparison of Five Regulatory Systems on Traditional Medicines with a Long History of Use

Table 3

Comparison of the listing of classic formulas.

Classic Chinese medicine formulation (China)Standard formulation of Chinese medicine (Taiwan)Established medicines (Hong Kong)Kampo medicines (Japan)Herbal drugs (Korea)

Legal warrant of the selected classic formulasFirst Batch of Classic Chinese Medicine Formulas Catalogue(1) Announcement No. 84056272 of drug Manufacturing of Department of Health;
(2) Announcement No. 89037929 and No. 0900002545 of Chinese Medicine Committee of Department of Health
Registration of Proprietary Chinese MedicinesThe Guidebook of the Approval Standards for OTC Kampo ProductsRegulation on Approval and Notification of Herbal (Crude) Medicinal Preparations, etc.
The amount of the selected classic formulas100 (first batch issued)200Not specified294Not specified
The representative bibliography of the selected classic formulasOriginated from 37 ancient medical books, including Shang Han Lun, Jin Kui Yao Lue, Jing Yue Quan Shu, Wen Bing Tiao Bian, Fu Qing Zhu Nv Ke, Yi Zong Jin Jian, Lan Shi Mi Zai, Wang Bing Hui Chun, Tai Ping Hui Min He Ji Ju Fang, et al.Shang Han Lun, Jin Kui Yao Lue, Tai Ping Hui Min He Ji Ju Fang, Yi Fang Ji Jie, Yi Zong Jin Jian, Wang Bing Hui Chun, Wai Ke Zheng Zong, et al.Chinese medicine bibliography in or before the Qing Dynasty, PRC Pharmacopoeia, National Drug Standards of PRCShang Han Lun, Jin Kui Yao Lue, He Ji Ju Fang, Wang Bing Hui Chun, Ji Sheng Fang, Wai Ke Zheng Zong, Ming Yi Zhi Zhang, Pi Wei Lun, Qian Jin Fang, et al.Donguibogam, Bangyakhapyeon, Hyangyakjipsungbang, Kyungakjeonseo, Uihakipmun, Jaejungshinpyeong, Kwangjaebigeop, Donguisoosebowon, Bonchogangmok, and “Provision on Types of Herbal Drug Prescription and Preparation Method”
The characteristic of each selected classic formula in the catalogueOriginal provenance (including description of TCM for functional indication), prescription component, preparation method, usage (definite quantity), and dosage formOriginal provenance, prescription component, dosage, dosage form, indication, and precautionNot specifiedCrude-drug component, dosage and administration, and indicationNot specified