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Health

scheme serves as a basis for the government to study how to formulate a statutory registration regime for the relevant accredited professions.

Western Medicines

Western medicines in Hong Kong are regulated under the Pharmacy and Poisons Ordinance. Acting on the authority of the Pharmacy and Poisons Board, the department evaluates and approves applications for the registration of pharmaceutical products, issues licences to drug manufacturers, wholesalers and retailers, and takes action against the illegal sale of controlled drugs. The department also enforces regulatory controls on poisons, antibiotics and dangerous drugs for medicinal use.

In 2020, the board approved 2,880 applications to register pharmaceutical products. As at 31 December, 15,396 pharmaceutical products were registered.

In July, Pharmacy and Poisons (Amendment) Bill to better regulate advanced therapy products was passed in the Legislative Council.

Chinese Medicines

Chinese medicines are regulated under the Chinese Medicine Ordinance, which requires any person engaged in the retail or wholesale of Chinese herbal medicines or the manufacture or wholesale of proprietary Chinese medicines to obtain a licence. The Chinese Medicine Council of Hong Kong is the statutory body that devises and implements regulatory measures for Chinese medicines. All proprietary Chinese medicines must be registered before they can be sold, imported or possessed in Hong Kong. As a transitional arrangement, proprietary Chinese medicines manufactured or sold in Hong Kong on 1 March 1999 are eligible for a transitional registration status if an application is made within a specified period and upon the submission of acceptable basic test reports. As at end-2020, there were 7,408 licensed Chinese medicine traders, including 21 holding the Certificate for Manufacturer; 5,585 proprietary Chinese medicines with transitional registration status; and 2,668 with a Certificate of Registration of proprietary Chinese medicines.

The Hong Kong Chinese Materia Medica Standards Project aims to ensure the safety and quality of common Chinese herbal medicines. It is supported by local universities and overseas and Mainland experts. As at 31 December, the department had released reference standards for 330 commonly used Chinese herbal medicines under the project.

The Government Chinese Medicines Testing Institute has started a number of research projects after consulting the industry, and has published research results on the Chinese Medicine Regulatory Office website.

The department's Chinese Medicine Regulatory Office, which is designated by the WHO as a WHO Collaborating Centre for Traditional Medicine, helps the WHO formulate policies and strategies and sets regulatory standards for traditional medicine.

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