The “1+” mechanism places emphasis on accepting international clinical trial data. Hong Kong’s Drug Office recognises results from cross-border clinical trials reviewed by internationally recognised regulatory authorities, provided that the data meet local scientific and ethical standards in Hong Kong. Applicants must provide complete reports on the trial design, conduct and results, and demonstrate compliance with the Clinical Trials Ordinance (Cap. 623) and relevant international guidelines, such as ICH-GCP. The data must also be transparent and traceable to ensure reliability. This helps reduce the need for duplicate trials and accelerate the local registration of new medicines.
HONG KONG DRUG LICENSING
How does the “1+” new drug approval mechanism handle the recognition of cross-border clinical trial data?
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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