A Certificate for Clinical Trial / Medicinal Test is not a “business licence” like a wholesale dealer or manufacturer licence. It is an “approval for a project” relating to a specific clinical research project. When a sponsor (usually a pharmaceutical company) plans to conduct a clinical trial in Hong Kong involving an unregistered medicine, or to study a new indication for a registered medicine, it must submit detailed study protocols, investigator information, technical documents on the medicine and other materials to the Department of Health to apply for this certificate. Only after the certificate has been obtained may investigators (doctors) lawfully administer the investigational medicine to trial participants, with exemption from the relevant drug registration and import and export licensing requirements.
HONG KONG DRUG LICENSING
What is a “Clinical Trial Certificate”? Is it a standalone licence? What do I need it for?
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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