<abstract xmlns="http://www.w3.org/1999/xhtml">
<p>The regulation of herbal medicines is changing and alters in the different countries. The Federal Food, Drug, and Cosmetic Act (FD&amp;C Act) defines medicines on the grounds of their intended use. Medicines shall be preliminarily approved by the FDA prior to their placing on the market or if they are OTC – they shall meet the requirements of specific regulations, called monographs, for their category. The definition of medicine according to the Canadian Food and Drugs Act (R.S.C., 1985, c. F-27) is “any substance or a combination of substances manufactured, sold or made available for use”. In Japan, the objective of the Medicines and Medical Products Act is to improve public health by means of regulations that are necessary to guarantee the quality, the efficiency and the safety of medicines, quasi-drugs, cosmetics, medical and medicinal products. The definition of a medicinal product in the EU has been specified in Section I Definitions of Directive 83/2001/EC. In the aforementioned countries under consideration, medicines are classified into: medicines prescribed by a doctor (POM) and medicines sold without a doctor’s prescription (OTC). The conducted comparative analysis of the aforementioned countries has shown that there are specific requirements and regulations for herbal medicinal products in the European Union. In the USA and Canada, herbal medicinal products are regarded as a subsection of the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act), sec. 351-360n-1 U.S.C. 379e; the Food and Drugs Act (R.S.C., 1985, c. F-27) – Government of Canada. In the Japanese legislation, there are no specific requirements for herbal medicinal products.</p>
</abstract>

The regulation of herbal medicines is changing and alters in the different countries. The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines medicines on the grounds of their intended use. Medicines shall be preliminarily approved by the FDA prior to their placing on the market or if they are OTC – they shall meet the requirements of specific regulations, called monographs, for their category. The definition of medicine according to the Canadian Food and Drugs Act (R.S.C., 1985, c. F-27) is “any substance or a combination of substances manufactured, sold or made available for use”. In Japan, the objective of the Medicines and Medical Products Act is to improve public health by means of regulations that are necessary to guarantee the quality, the efficiency and the safety of medicines, quasi-drugs, cosmetics, medical and medicinal products. The definition of a medicinal product in the EU has been specified in Section I Definitions of Directive 83/2001/EC. In the aforementioned countries under consideration, medicines are classified into: medicines prescribed by a doctor (POM) and medicines sold without a doctor’s prescription (OTC). The conducted comparative analysis of the aforementioned countries has shown that there are specific requirements and regulations for herbal medicinal products in the European Union. In the USA and Canada, herbal medicinal products are regarded as a subsection of the Federal Food, Drug, and Cosmetic Act (FD&C Act), sec. 351-360n-1 U.S.C. 379e; the Food and Drugs Act (R.S.C., 1985, c. F-27) – Government of Canada. In the Japanese legislation, there are no specific requirements for herbal medicinal products.

Pharmaceutical Regulation of Herbal Medicinal Products in the Countries of the European Union, the USA, Canada and Japan

Department of Pharmaceutical Technology and Biopharmacy, Faculty of Pharmacy

Department of Social Pharmacy, Faculty of Pharmacy

Acta Medica Bulgarica

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

The regulation of herbal medicines is changing and alters in the different countries. The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines medicines on...

Pharmaceutical Regulation of Herbal Medicinal Products in the Countries of the European Union, the USA, Canada and Japan

Published Online: Sep 29, 2023

Page range: 71 - 74

Received: Dec 02, 2022

Accepted: Dec 22, 2022

DOI: https://doi.org/10.2478/amb-2023-0034

Keywords
pharmaceutical legislation, herbal medicinal product, regulation

© 2023 B. Hadzhieva et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Pharmaceutical Regulation of Herbal Medicinal Products in the Countries of the European Union, the USA, Canada and Japan

Published Online: Sep 29, 2023

Page range: 71 - 74

Received: Dec 02, 2022

Accepted: Dec 22, 2022

DOI: https://doi.org/10.2478/amb-2023-0034

Keywordspharmaceutical legislation, herbal medicinal product, regulation

© 2023 B. Hadzhieva et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Keywords
pharmaceutical legislation, herbal medicinal product, regulation