¹Pravin Kumar Singh, ²Dr. Vikesh Kumar Shukla, ³Dr. Amrish Chandra

 DOI : http://dx.doi.org/10.31142/ijahm/v11i2.03

¹M. Pharm Drug Regulatory Affairs, Amity Institute of Pharmacy, Amity University Noida

²Associate professor, Department of pharmaceutics & Dra, Amity institute of pharmacy, Amity University, l-1 block sector -125, Noida, Uttar Pradesh India

^3*Associate Professor, Registered Patent Agent (IN/PA-2959), Govt. of India, Centre for Drug Regulatory Affairs & Pharmacy Practice, Amity Institute of Pharmacy, Amity University l-1 block sector -125, Noida, Uttar Pradesh India

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Abstract: Herbal medicine was used around the world for many centuries and it is still in use by society quite extensively. Herbal medicines have a very significant role in international trade. Herbal medicine recognition is widely growing around the world on the merit of their clinical, pharmaceutical and economic value. Herbal medicine classification varies from country to country such that in the USA it comes under Dietary supplement and Botanical drugs, Natural Health Product term is used in Canada. In the USA and Canada, Herbal products are mainly used by the younger generation. The present review deals with import regulation requirement of herbal medicine in the USA and Canada. In both countries, it is regulated by USFDA and Health Canada. Herbal medicine market of USA and Canada is growing at a healthy rate. Importers must follow the regulatory requirements of USFDA and Health Canada for fluid marketing approval for their product.

Key word: Herbal medicine, Dietary supplement, Natural health product, USFDA, Health Canada

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