Hong Kong medicine registration does not usually require applicants to submit local clinical trial data, but sufficient international clinical research information must be provided to demonstrate the medicine’s safety and efficacy. If the clinical data submitted comes from internationally recognised regulatory authorities or literature, the Drug Office will accept it. For innovative medicines or special indications, the Drug Office may also request supplementary information. Overall, Hong Kong’s registration process places greater emphasis on international data supporting medicine quality and safety.
HONG KONG DRUG LICENSING
When applying for a Hong Kong pharmaceutical licence, is clinical trial data required?
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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