In Hong Kong, proprietary Chinese medicines are generally regarded as medicines and are regulated under the Pharmacy and Poisons Ordinance (Cap. 138). They require a pharmaceutical licence and must comply with requirements on medicine safety, ingredients and labelling. Health foods do not fall within the category of medicines and are primarily regulated under the Trade Descriptions Ordinance (Cap. 362) and the Food Safety Ordinance (Cap. 612), with an emphasis on food safety and accurate labelling. If a proprietary Chinese medicine contains medicinal ingredients or makes therapeutic claims, it must go through the pharmaceutical licensing approval process; health foods must not claim to treat or prevent disease. Correct classification helps businesses avoid compliance risks.
HONG KONG DRUG LICENSING
How are proprietary Chinese medicines distinguished from health foods in Hong Kong’s regulatory classification?
A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.
Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.
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