Pharmaceutical regulation of herbal medicinal products in the countries of the European Union, the USA, Canada and Japan

Abstract

The regulation of herbal medicines is changing and alters in the diff erent countries. The Federal Food, Drug, and Cosmetic Act (FD&C Act) defi nes 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 specifi c regulations, called monographs, for their category. The defi nition 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 effi ciency and the safety of medicines, quasi-drugs, cosmetics, medical and medicinal products. The defi nition of a medicinal product in the EU has been specifi ed in Section I Defi nitions of Directive 83/2001/EC. In the aforementioned countries under consideration, medicines are classifi ed 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 specifi c 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 specifi c requirements for herbal medicinal products.