The “1+” new drug approval mechanism is an expedited approval pathway established by the Drug Office, Department of Health, to accelerate the introduction of innovative and promising new medicines to the local market. It primarily applies to innovative medicines, biologics and certain medicines for rare diseases being submitted for registration in Hong Kong for the first time. The mechanism focuses on existing approval data from internationally recognised drug regulatory authorities (such as the FDA and EMA), reducing duplicate review work and thereby shortening approval times. It does not apply to generic medicines or over-the-counter medicines already registered locally. The aim is to encourage innovative pharmaceutical companies to accelerate their expansion into overseas markets and enhance Hong Kong’s competitiveness as a regional pharmaceutical innovation hub.
HONG KONG DRUG LICENSING
What is the “1+” new drug approval mechanism, and which categories of new drugs does it specifically cover?
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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