ENG-2009 — Page 232

172 Health

practitioners with limited registration) and listed respectively with the Chinese Medicine Council of Hong Kong.

Western Medicines

The regulation of western medicines in Hong Kong is stipulated under the Pharmacy and Poisons Ordinance. Acting on the authority of the Pharmacy and Poisons Board, the Department of Health registers and approves the marketing of pharmaceutical products, issues licences to drug manufacturers, importers, wholesalers and retailers, and takes action against illegal sale of controlled drugs in collaboration with the Hong Kong Police Force. Legislative controls are also enforced on poisons, antibiotics and dangerous drugs.

During 2009, 5 013 applications for registration of pharmaceutical products were approved. At year-end, 19 588 pharmaceutical products were registered in Hong Kong.

In light of incidents concerning pharmaceutical products in the first quarter of 2009, the Government set up the Review Committee on the Regulation of Pharmaceutical Products on March 24, 2009 to conduct a comprehensive review on the existing regime for the regulation and control of pharmaceutical products.

The committee's report, completed at the end of 2009, put forward 75 recommendations on all aspects of the current drug regulatory regime, including manufacturing, distribution, import and re-export, procurement, supply of drugs and delivery to the public and private sectors, control of pharmaceutical products, pharmacovigilance, and penalties for non-compliance as well as risk communication, education and training. In the next step, the Government will work with the pharmaceutical sector to implement the recommendations.

Chinese Medicines

The regulation of Chinese medicines is subject to the Chinese Medicine Ordinance. Any person engaged in the retailing or wholesale of Chinese medicines or the manufacture or wholesale of proprietary Chinese medicines (pCm), is required to obtain a licence. Any pCm sold, imported or possessed in Hong Kong must be registered. The Chinese Medicine Council of Hong Kong is now the responsible body for devising and implementing regulatory measures for Chinese medicine. Applications for Chinese medicine trader licences and for registration of proprietary Chinese medicines have been accepted since April and December 2003 respectively.

As a transitional arrangement, pCm that are manufactured or sold on March 1, 1999 are eligible for obtaining a transitional registration status. By the end of 2009, there are 7 353 licensed Chinese medicine traders (including 2 406 holding transitional licences), and 8984 pCm have obtained the transitional registration

status.

Human Organ Transplantation

Under the Human Organ Transplant Ordinance, transplant of human organs and importation of human organs for transplant purposes are regulated, and commercial dealings in human organs intended for transplant are prohibited. Approval from the