Under the ‘1+’ approval mechanism, new medicines that have already received international approval can gain access to the Hong Kong market significantly faster. The traditional approval process can take a year or longer, whereas the ‘1+’ mechanism can reduce the approval time to within 6 months, or even less. This offers considerable strategic value to innovative pharmaceutical companies seeking to enter the Hong Kong and Greater China markets quickly. Faster access can also help secure a market advantage and strengthen competitiveness, while reducing the time and capital required and enabling commercial returns to be realised sooner.
HONG KONG DRUG LICENSING
What impact does the “1+” new drug approval mechanism have on the market access timeline in Hong Kong for medicines already approved internationally?
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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