The health authorities of Hong Kong and Canada have recently signed "Plan of Action for Regulatory Cooperation on Natural Health Products" to further enhance their cooperation in the regulation of NHP. It came into effect immediately and will be reviewed prior to the expiry of the four-year term. Natural health product (NHP) include vitamins, minerals and traditional Chinese medicines (TCM).
The Plan of Action is formulated to establish a clear framework for communication, maintaining ongoing dialogue, developing mechanisms for joint collaboration and exchange of relevant information on NHP between Hong Kong and Canada.
It will enhance the safety, quality and efficacy of NHP and strengthen reciprocal knowledge, understanding and updates of regulatory frameworks of the two places.
Under the Plan of Action, the areas of cooperation between Hong Kong and Canada include:
- exchange of information such as monographs, pharmacopoeia, standards, guidelines, terminology of natural health products;
- communication of adverse reaction reports, recalls, and other public warnings; and
- conduction of joint workshops, technical exchanges and visits
Non-TCM herbal and health foods are not regulated. However, some products usually regarded as health foods in North America could be regarded as drugs (eg. Vitamins).
Claims for drugs and health foods are regulated by the Hong Kong Law “Chapter 231 UMAO (Undesirable Medical Advertisement Ordinance).”
The Chinese Medicine Ordinance (Cap. 549 of the Laws of Hong Kong) was passed by the Legislative Council on 14 July 1999. The regulatory system for Chinese medicine established under the Ordinance on the one hand, can enhance the protection of public health and on the other hand, accord a professional status for Chinese medicine practitioners and ensure the safety, quality and efficacy of Chinese medicines.
The contents of the Chinese Medicine Ordinance include the composition and functions of the Chinese Medicine Council, Chinese Medicine Practitioners Board, Chinese Medicines Board and the seven committees established under the Chinese Medicine Council; the regulatory system for Chinese medicine practitioners, which includes registration, examination and discipline of Chinese medicine practitioners; and the regulatory system for Chinese medicines, which includes licensing and regulation of Chinese medicines traders and registration of proprietary Chinese medicines. In addition, the Ordinance contains Schedule 1 of 31 types of potent/toxic Chinese herbal medicines and Schedule 2 of 574 types of Chinese herbal medicines.
In Hong Kong, pharmaceutical products must be registered with the Department of Health in accordance with the Pharmacy and Poisons Ordinance. Some vitamins and dietary supplements products are considered pharmaceutical products by the Department of Health, but other health supplement products do not need to be registered. In deciding whether or not a product is a ‘pharmaceutical product’, the Department of Health takes into account the composition of the product and nature of the claims made in the labels, leaflets, brochures, wrappers, advertisements and other promotional materials of the product. In general, products carrying ‘medicinal’ claims fall within the meaning of pharmaceutical products and must be registered.
Useful Links:
The Hong Kong Health Food Association (HKHFA)
MODERNIZED CHINESE MEDICINE INTERNATIONAL ASSOCIATION
PHARMACEUTICAL SERVICE DEPARTMENT OF HEALTH