Drugs and Medical Devices
Responsible Authority:
Pharmacy and Poisons Board
Chinese Medicine Board
(supported by the Department of Health)
Ordinance(s)/Regulation(s) and Brief Description:
The Pharmacy and Poisons Ordinance (Cap 138), the Antibiotics Ordinance (Cap 137), the Dangerous Drugs Ordinance (Cap 134) and the Food and Drugs (Composition and Labelling) Regulations (Cap 132W) provides for the control of manufacture, import, sale, possession and use of pharmaceutical products, antibiotics and dangerous drugs.
The Chinese Medicine Ordinance (Cap 549) provides for the control of licensing of traders in Chinese medicine and registration of proprietary Chinese medicines.
There is no legislation on the regulation of medical devices except those with irradiating substance or pharmaceutical products.
Conformity Assessment Mechanism:
Pre-market registration and licensing:
The Pharmacy and Poisons Board issues licences to qualified drug manufacturers, importers, wholesalers and retailers. In addition, a pharmaceutical registration and an import/export control system are in place to ensure that only registered pharmaceutical products are manufactured, imported or sold for local consumption. Pharmaceutical products applying for registration are assessed on the basis of their safety, efficacy and quality.
The Chinese Medicines Board issues licences to qualified wholesalers and retailers of Chinese herbal medicines and manufacturers and wholesalers of proprietary Chinese medicines. The Chinese Medicines Board also assesses the application for registration of proprietary Chinese medicines, on the basis of their safety, efficacy and quality.
Post-market surveillance:
The Department of Health ensures conformity to the Ordinances by inspection, test purchase and sampling of products for analysis.
Standards:
| Domestic Standards Made | International/National Standards Accepted |
|---|---|
N/A |
According to Food and Drug (Composition and Labelling) Regulation, drugs and ingredient and component parts of drugs for local consumption shall conform to the standards specified thereof respectively in the British Pharmacopoeia or British Pharmacopoeia Codex. A manufacturer's compliance with the Code of Good Manufacturing Practice as recommended by the World Health Organisation (WHO) is a mandatory requirement for the registration of pharmaceutical products. Proprietary Chinese medicines manufacturers who comply with good manufacturing practice in proprietary Chinese medicines are eligible to apply for Certificate for Manufacturer from the Chinese Medicines Board. |
