Table 3.

Regulatory authorities and registration pathways of traditional herbal medicines (HMs) in selected countries.

Country	Regulatory authority	Registration pathways of HMs with disease claims
China	National Medical Products Administration; National Administration of Traditional Chinese Medicine	Drugs in accordance with Provisions for Drug Registration
India	Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy	Drugs in accordance with the Drug and Cosmetic Act 1940
South Korea	Korea Food and Drug Administration	Herbal medicines in accordance with Pharmaceutical Affairs Act
USA	Federal Food and Drug Administration	Botanical drugs in accordance with Guidance for Industry-Botanical Drug Products
Australia	Therapeutic Goods Administration	Complementary medicines in accordance with Therapeutic Goods Act 1989
Germany	Federal Institute for Drugs and Medical Devices; European Medicines Agency	Traditional herbal medicinal products in accordance with directive 2004/24/EC or
		Medicine for human use by Marketing Authorization in accordance with directive 2001/83/EC
UK	Medicines and Healthcare products Regulatory Agency	HMs in accordance with Traditional Herbal Registration scheme or
		Medicine for human use by Marketing Authorization in accordance with directive 2001/83/EC