Clinical trials conducted in Hong Kong for the purpose of obtaining pharmaceutical product registration must comply with requirements that are stricter than those for routine medicine management. First, the sponsor (usually a pharmaceutical company) must apply to the Department of Health for a “Certificate for Clinical Trial/Medicinal Test”. The application must include a detailed trial protocol, Investigator’s Brochure, sample informed consent form and approval documents from the ethics committee (IRB/IEC). Second, the labelling, manufacture, packaging and distribution of all investigational medicinal products (IMPs) must meet the specific requirements of GMP and relevant guidelines, ensuring that their quality and blinding are not compromised. Third, all serious adverse events (SAEs) occurring during the trial must be reported to the Department of Health within the prescribed time limits. The entire trial must strictly follow the principles of Good Clinical Practice (GCP).
HONG KONG DRUG LICENSING
What additional regulatory requirements apply in Hong Kong if our medicines need to undergo clinical trials?
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.
Back to Category H: Licensed Operations and Routine Oversight (Q351-Q400) Search more questions