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| | China | Taiwan | Hong Kong | Japan | Korea |
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| The general concept of TM/CM products |
| Terminologya | Traditional Chinese medicines (TCMs) | Kampo medicines | Traditional Korean medicine |
| Descriptiona | The traditional medicine that originated in China and is characterized by holism and treatment based on pattern identification/syndrome differentiation | System of herbal medicine practiced in Japan by both herbalists and practitioners of modern medicine. They are extracts or dry powders made from a mixture of naturally derived herbal medicines. They originated from ancient Chinese medicine and have evolved to the Japanese original style over a long period of time | Medical practice or discipline that is based on the knowledge, cultures, and beliefs of the people of Korea |
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| The specific concept of TM/CM products with a long history of use |
| Terminology | Classic Chinese medicine formulation | Standard formula of Chinese medicine | Established medicine | Kampo medicine | Herbal drug |
| 古代經典名方中藥複方製劑 | 基準方劑 | 固有藥 | 漢方製劑 |
| Description | It refers to the prescription recorded in the ancient Chinese medical book, which is still widely used, with definite curative effect and obvious characteristics and advantages [46] | It refers to a formulation selected and published by drug regulatory authority that has unified specification and determination in the dosage form and formula contents [47] | It refers to (1) an ancient prescription documented in Chinese medicine bibliography in, or before, the Qing dynasty; (2) a modified ancient prescription based on an ancient prescription with reasonable and rational modifications; (3) a pharmacopoeia prescription documented in the Pharmacopoeia of PRC; or (4) any other prescriptions originating from the National Drug Standards of the PRC and accepted by the Chinese Medicines Board [48] | It refers to traditional Japanese herbal medicine used in Japan for more than 1500 years [49]. It includes ethical Kampo formulations and OTC Kampo formulations [50]. Ethical Kampo formulation is synonymous with Kampo formulation for prescription. | It refers to plant-derived materials and preparations with therapeutic or other human health benefits, which contain either raw or processed ingredients from one or more plants, inorganic materials, or animal origin [51] |
| Regulatory agency | National Medical Products Administration of China | The Department of Chinese Medicine and Pharmacy, the Ministry of Health and Welfare | (1) Registration authority: Chinese Medicine Council of Hong Kong, Chinese Medicine Division of the Department of Health
(2) Postmarketing: Drug office of the Department of Health | The Ministry of Health, Labour and Welfare; the Pharmaceuticals and Medical Devices Agency | Ministry of Food and Drug Safety of Korea
(1) Market authorization: Herbal Medicine Product Division, Biopharmaceuticals and Herbal Medicine Bureau
(2) Registration authority: Herbal Medicines Products Division, Biopharmaceuticals and Herbal Medicines Evaluation Department |
| Legislation | Law of the People's Republic of China on Traditional Chinese Medicine, 2016;
Pharmaceutical Administration Law, 2019;
Provisions for Drug Registration, 2020;
Administrative Regulations on Simplified Registration Evaluation and Approval of Classic Chinese medicine Formulation, 2018 | Chinese Medicine and Pharmacy Development Act, 2019; Pharmaceutical Affairs Act, 2018;
Regulations for Registration of Medicinal Products, 2020;
the Regulation on the Preparations of Inherited Formulation and Over-the-Counter Drugs, 2018 | The Chinese Medicine Ordinance (Cap. 549 of the Laws of Hong Kong), 1999 | Pharmaceutical Administration and Regulations in Japan, 2020; the Guidebook of the Approval Standards for OTC Kampo Products, 2017 | Pharmaceutical Affairs Act, 2016;
Regulation on Safety of Pharmaceuticals, 2018;
Regulation on Approval and Notification of Herbal (Crude) Medicinal Preparations, 2015 |
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