Hong Kong's regulation of traditional herbal medicines depends mainly on their source and category. If a herbal medicine falls within the categories of “Chinese herbal medicine” or “proprietary Chinese medicine”, it is subject to comprehensive regulation under the Chinese Medicine Ordinance (Cap. 549). The trader must apply for a Chinese medicine trader licence, and the product (if it is a proprietary Chinese medicine) must also be registered. However, the legal status of “traditional herbal medicines” outside the Chinese medicine system (for example, Western herbal remedies such as St John's wort and echinacea) is less clear. They are generally regulated as ordinary foods or health products, provided they contain no Western medicine ingredients controlled under the Pharmacy and Poisons Ordinance and their claims do not relate to the treatment or prevention of disease. The Department of Health nevertheless monitors these products closely and may investigate if they are found to contain harmful substances or make false medical claims.
HONG KONG DRUG LICENSING
How are Traditional Herbal Medicines regulated in Hong Kong?
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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