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Hong Kong-The Progress of Regulatory work of Chinese Medicine
The Chinese Medicine Ordinance (the Ordinance) was enacted in 1999 by the Legislative Council to provide a statutory framework for the regulation of Chinese medicine. Chinese Medicine Council of Hong Kong, established in the same year, is supported by the Chinese Medicine Practitioners Board (Practitioners Board) and the Chinese Medicines Board (Medicines Board) in carrying out relevant regulatory functions.
Regulation of Chinese Medicine Practitioners
Chinese medicines practitioners are regulated through a system of registration, licensing examination and discipline. Any person who intends to practice Chinese medicine in Hong Kong must have satisfactorily completed an undergraduate degree course in Chinese medicine practice, or its equivalent, as is approved by the Practitioners Board; have passed the Chinese Medicine Practitioner Licensing Examination; and registered as a registered CMP. Registered CMPs must fulfill the requirements of continuing education in Chinese medicine before they can renew their practicing certificates. There are currently about 5,250 registered CMPs in Hong Kong.
The Ordinance has provided for a transitional arrangement to allow those CMPs who had been practising Chinese medicine before the implementation of the registration system to continue to practise as listed CMPs. There are currently 2,900 listed CMPs. The Ordinance has also provided for a system of “limited registration” to facilitate the engagement of overseas or Mainland Chinese medicine experts by six educational or scientific research institutions to conduct clinical teaching or research in Chinese medicine.
To protect the rights of the patients and to uphold the professional conduct and standards of CMPs, the Practitioners Board has compiled codes of practice to regulate the practice of CMPs.
Regulation of Chinese Medicines
The regulatory measures of Chinese medicines include the licensing of Chinese medicines traders and the registration of proprietary Chinese medicines (pCms). Four types of Chinese medicines traders (namely, retail or wholesale of Chinese herbal medicines (CHMs), or manufacture or wholesale of pCms) are required to apply for a licence and comply with the laws and the relevant practicing guidelines. Since May 2003, the Medicines Board has approved 6,900 applications for trader licence in Chinese medicines. 31 toxic CHMs are specified in Schedule 1 and 574 commonly-used CHMs are listed in Schedule 2 of the Ordinance. When the relevant laws are commenced, traders are required to apply for import or export licence for importing or exporting the Schedule 1 CHMs and five specified Schedule 2 CHMs.
Since December 2003, the Medicines Board has received about 16,000 applications for registration of pCms. The Medicines Board shall, in determining an application for pCm registration, take into consideration the safety, quality and efficacy of the product. pCms are registered under three categories (namely, established medicines, non-established medicines and new medicines) and three registration groups (i.e. groups I, II and III) according to the product nature. The laboratories conducting tests on pCms must meet the standards of the International Standardization Organization (i.e. ISO/ IEC 17025) or Good Laboratory Practice.
Hong Kong Chinese Materia Medica Standards (CMMS)
The Hong Kong Chinese Materia Medica Standards project was launched in 2002 by the Department of Health. It aims to provide recommendations and references regarding the quality and safety aspects of 60 commonly used Chinese herbal medicines in Hong Kong. The HKCMMS (Volume One) covering 8 Chinese herbal medicines was published in July 2005. The publication of Volume 2 containing the monographs of 24 Chinese herbal medicines is in progress. The research work of Phase III covering 28 herbs commenced in early 2006.
Department of health
March 2007
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