How is Chinese medicine regulated in Hong Kong? How does its regulation differ from that of Western medicines?

Since the Chinese Medicine Ordinance (Cap. 549) came into force in 1997, Hong Kong has developed an independent and comprehensive legal framework for regulating Chinese medicine. The framework is administered by the Chinese Medicine Regulatory Office (CMRO) under the Department of Health. As with Western medicines, regulation covers both product registration and business licensing. All “proprietary Chinese medicines” sold in Hong Kong must be registered with the Chinese Medicines Board to demonstrate their safety, quality and stability. Companies engaged in Chinese medicine business must also apply for the appropriate licences according to the nature of their business, including licences for the retail of Chinese herbal medicines, wholesale of Chinese herbal medicines, wholesale of proprietary Chinese medicines and manufacture of proprietary Chinese medicines. One difference is that the regulation of Chinese medicine takes account of the particular nature of its traditional use. For example, when registering proprietary Chinese medicines, the requirements for evidence of safety and efficacy may differ between “classical formulae” with a long history of use and newly developed formulae. There are also specific testing standards for pesticide residues and heavy metal content in Chinese herbal medicines.