(2002; 166 pages)
Regulation of traditional Chinese medicines in Hong Kong, China
Dr Margaret Chan, Hong Kong SAR, China
The objectives of regulation of Chinese medicines in Hong Kong are: to safeguard public health, and to ensure the availability of good quality and effective Chinese medicines to the people of Hong Kong, China.
Traditional Chinese medicines have been used by the people of Hong Kong for more than 150 years. For historical reasons, no specific forms of regulation of TCM were in place in Hong Kong in the past. Article 138 of the Basic Law of Hong Kong Special Administrative Region provides that the Government of the Region shall formulate policies to develop western and traditional Chinese medicines and to improve medical and health services. In 1989, the Working Party on TCM was formed. A consensus on the principles of TCM regulation has been reached. The principles are: to safeguard public health, to recognize TCM as part of the health care system, and to adopt an incremental approach to upgrade the standards of practice and the safety, quality and efficacy of herbal medicines based on evidence. In 1995, the Preparatory Committee on Chinese Medicines was formed and worked on the details of TCM regulation. The vision for TCM regulation and development was well summarized in the Policy Address of the Chief Executive of Hong Kong SAR in 1997, in which the Region’s Government was committed to:
• regulate Chinese medicine to protect public health;
• promote the integration of Chinese medicine with western medicine;
• develop Hong Kong into an international centre for research, training, information, manufacture and trade of Chinese medicine.
In 1999, the Chinese Medicine Ordinance was enacted. The Chinese Medicine Council, which is an independent, statutory body responsible for implementing regulatory measures on Chinese medicine, was established under the Ordinance in September 1999. Working under the Council, the Chinese Medicines Board and its three committees are responsible for formulating and implementing the regulatory measures on Chinese medicines.
The Chinese Medicine Ordinance defines Chinese herbal medicine as any of the substances specified in Schedule 1 or 2 to the Ordinance. Schedule 1 is a list of 31 potent herbs which can only be dispensed on a prescription issued by a registered Chinese medicine practitioner. Schedule 2 includes 574 Chinese herbal medicines commonly used in Hong Kong. Wholesalers and retailers of Chinese herbal medicines will be required to obtain a licence. The import and export of every consignment of Chinese herbal medicines must be covered by an appropriate licence. Activities are in progress to develop standards for raw and processed herbs, with the assistance of experts and institutions in Hong Kong, other parts of China, and overseas.
Wholesalers and manufacturers of proprietary Chinese medicines will be required to obtain a licence. It will be compulsory for traders in proprietary Chinese medicines to report any adverse drug reactions (ADR) to the Chinese Medicines Board. Proprietary Chinese medicines sold or manufactured in Hong Kong will have to be registered with the Chinese Medicines Board. Registration will be based on evidence of safety, quality and efficacy. Initially, for practical reasons, provisions will be made for transitional registration; under these provisions, for a specified time, an application may be made to register any proprietary Chinese medicine that was sold or manufactured in Hong Kong on or before 1 March 1999. On receipt of the application, the proprietary Chinese medicine will be deemed to be registered. However, manufacturers or importers will be required in due course to submit evidence of safety, quality and efficacy in order to obtain formal registration.
In future, in order to safeguard public health, Hong Kong SAR will:
• continue the work of regulation of Chinese medicines;
• develop regulatory standards for selected herbs;
• set up a monitoring system for adverse reactions to herbal products;
• support evidence-based clinical research in Chinese medicines;
• promote industrial development and protection of intellectual property;
• enhance regional and international collaboration.