Combination products containing both Western and Chinese medicines are subject to very close scrutiny in Hong Kong and are usually classified and regulated as Western medicines. Under the Pharmacy and Poisons Ordinance, any product containing a Western medicine ingredient listed in the Poisons List is classified as a “pharmaceutical product”, whether or not it also contains Chinese medicine ingredients. Such a product must therefore follow the full Western medicine regulatory pathway: it must be registered with the Pharmacy and Poisons Board (PPB) (and obtain an HK-XXXXX number), and its manufacturer, importer and distributor must hold the relevant Western medicine licences, such as a manufacturer’s licence or wholesaler’s licence. In assessing the product, the regulator will evaluate the safety and quality of both its Western and Chinese medicine ingredients. Claiming that a product is “all natural” or “herbal” when it has been found to contain illegally added Western medicine ingredients is an offence that regulators crack down on severely.
HONG KONG DRUG LICENSING
How will my product be regulated if it is a combination preparation containing both Western and Chinese medicines?
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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