The “1+” new drug approval mechanism primarily applies to innovative medicines being registered in Hong Kong for the first time, including new chemical entities, biologics and some medicines for rare diseases. However, it does not apply to generic medicines, over-the-counter medicines or similar products already registered in the Hong Kong market. It also does not apply to medicines with significant safety concerns or without sufficient support from international certification. The mechanism is designed to focus on innovation and international recognition, ensuring that medicines approved through the expedited process have a sound basis for safety and efficacy and thereby protecting public health.
HONG KONG DRUG LICENSING
Does the “1+” new drug approval mechanism apply to all types of innovative medicines? What are its limitations?
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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