Regulation of Chinese Medicines

According to the Chinese Medicine Ordinance, regulatory measures relating to Chinese medicines shall be divided into two areas as follows:

  1. The licensing of Chinese medicines traders: Chinese medicines traders who wish to engage in the business of retail and wholesale of Chinese herbal medicines as well as the wholesale and manufacturing business of proprietary Chinese medicines must first apply for the relevant licence from the Chinese Medicines Board. They may continue operating their own business only after they have obtained the licence.

  2. The registration of proprietary Chinese medicines: All kinds of proprietary Chinese medicines must first be registered by the Chinese Medicines Board before they can be imported, manufactured and distributed in Hong Kong.

According to the Chinese Medicine Ordinance, Chinese herbal medicines mean the toxic Chinese herbal medicines specified in Schedule 1 of the Ordinance and the Chinese herbal medicines specified in Schedule 2 of the Ordinance which are commonly used in Hong Kong.

And "proprietary Chinese medicine" means any proprietary product -

  1. composed solely of the following as active ingredients-

    1. any Chinese herbal medicines,
    2. any materials of herbal, animal or mineral origin customarily used by the Chinese; or
    3. any medicines and materials referred to in subparagraphs (i) and (ii) respectively;
  2. formulated in a finished dose form; and

  3. known or claimed to be used for the diagnosis, treatment, prevention or alleviation of any disease or any symptom of a disease in human beings, or for the regulation of the functional states of the human body;

The Chinese Medicines Board has formulated the "Guidance Notes on How to Classify Products as proprietary Chinese medicines".  For details please refer to the contents of this guideline.

Apart from the foregoing restrictions, according to the Import and Export Ordinance (Cap.60 of the Laws of Hong Kong), any person who wishes to import or export any of the Chinese herbal medicines specified in Schedule 1 or the 5 types of the Chinese herbal medicines specified in Schedule 2 as well as any proprietary Chinese medicines must first apply for an import or export licence.

Besides, the Protection of Endangered Species of Animals and Plants Ordinance (Cap. 586) imposes regulation on proprietary Chinese medicines containing ingredients of endangered species. For more information, please refer to the pamphlet on "Endangered Species Protection - Traditional Chinese Medicines" published by the Agriculture, Fisheries and Conservation Department.

The legislations including the Chinese Medicine Ordinance, Chinese Medicines Regulation, Chinese Medicines (Fees) Regulation and Chinese Medicines Traders (Regulatory) Regulation should be taken as the standards for regulation of Chinese medicines. The Laws of Hong Kong can be downloaded from the Internet (Website: www.elegislation.gov.hk). Otherwise, you can purchase the publication(s) by: