To qualify for the “1+” new drug approval mechanism, the following conditions must be met: first, the medicine must be an innovative new drug or a drug being submitted for registration in the Hong Kong market for the first time; second, the applicant must demonstrate that the drug has been approved by at least one internationally authoritative drug regulatory authority; third, complete clinical and quality data must be submitted in accordance with local Hong Kong regulatory requirements; and finally, the applicant must have a lawful local registration representative or agent. Only applications meeting these conditions may benefit from a shortened approval timeline, priority review and other measures to improve review efficiency.
HONG KONG DRUG LICENSING
What specific conditions must be met to apply under the “1+” new drug approval mechanism?
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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