By simplifying the approval process and shortening the approval period, the “1+” new drug approval mechanism provides important support for innovative pharmaceutical companies seeking to obtain a drug licence in Hong Kong more quickly. As an international financial and healthcare hub, successful medicine registration in Hong Kong can serve as a springboard into the Greater China region and wider Asian markets, strengthening companies’ competitiveness. In addition, recognition of data from internationally recognised regulatory authorities helps reduce the cost of duplicate trials and improve the efficiency of new drug development. For innovative pharmaceutical companies, this means products can be commercialised earlier, cash flow optimised and global expansion strengthened, significantly improving the likelihood and speed of successful expansion into overseas markets.
HONG KONG DRUG LICENSING
What is the strategic significance of the “1+” new drug approval mechanism for innovative pharmaceutical companies expanding into overseas markets?
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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