What are Hong Kong’s main drug regulatory authorities, and what are their respective responsibilities?

Several bodies are involved in Hong Kong’s medicine regulatory system. Each has its own responsibilities, and together they safeguard medicine safety. The main bodies include: 1. **Drug Office, Department of Health**: The central executive body, responsible for most regulatory functions under the Pharmacy and Poisons Ordinance and the Chinese Medicine Ordinance. Its duties include reviewing medicine registration applications; assessing and issuing various pharmaceutical licences for manufacturers, wholesalers and retailers; controlling medicine imports and exports; monitoring and inspecting medicines; and recalling medicines. 2. **Pharmacy and Poisons Board (PPB)**: A statutory body mainly responsible for pharmacist registration and disciplinary matters, as well as licensing and regulating Authorised Sellers of Poisons (that is, pharmacies). Applications for medicine product registration are also initially reviewed by the Drug Office before being submitted to a committee under the PPB for final approval. 3. **Chinese Medicine Regulatory Office (CMRO)**: Part of the Department of Health, it is specifically responsible for administering the Chinese Medicine Ordinance and regulating Chinese herbal medicines and proprietary Chinese medicines, including the licensing of Chinese medicine traders, registration of proprietary Chinese medicines and registration of Chinese medicine practitioners. Together, these three bodies form the core of Hong Kong’s medicine regulatory system, ensuring that western and Chinese medicines, products and practitioners are all subject to close legal regulation.