ENG-2011 — Page 226

186 Health

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 DH evaluates and approves the applications for the registration of pharmaceutical products, issues licences to drug manufacturers, importers and exporters, wholesalers and retailers, and takes action against the 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 2011, 3 858 applications for registration of pharmaceutical products. were approved. At year-end, 18 903 pharmaceutical products were registered in Hong Kong.

In the 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 completed the review and submitted a report at the end of 2009, putting forward 75 recommendations on all aspects of the current drug regulatory regime, including manufacturing, distribution, import and re-export control, sale, supply and procurement of drugs in the public and private sectors, control of pharmaceutical products, pharmacovigilance, penalties for non-compliance as well as risk communication, education and training. The report was accepted by the Legislative Council Panel on Health Services in January 2010. The DH set up a steering committee at the beginning of 2010 for co-ordination and implementation of the committee's recommendations, and reorganised the Pharmaceutical Service into the Drug Office in September 2011 to strengthen existing drug regulatory activities.

Chinese Medicines

The regulation of Chinese medicines is stipulated under 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. After obtaining a licence, the manufacturers may apply for a Certificate for Manufacturer, certifying that they follow the requirements of Good Manufacturing Practice (GMP) in manufacture and quality control of pCm. Any pCm sold, imported or possessed in Hong Kong must be registered. The Chinese Medicine Council of Hong Kong is the statutory body responsible for devising and implementing regulatory measures for Chinese medicines. 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 manufactured or on sale on March 1, 1999 are eligible for a transitional registration status upon submission of acceptable basic test reports. By the end of 2011, there were 6 591 licensed Chinese medicine traders (including eight holding Certificate for Manufacturer), and 9 118 pCm have obtained the transitional registration status.