The “1+” new drug approval mechanism supports registration applications for innovative medicines developed through cross-border collaboration. Applicants may submit clinical and registration data from partners in other countries or regions and draw on internationally recognised data to accelerate the approval process. The mechanism also encourages cross-border data sharing and regulatory coordination, simplifying the acceptance of clinical trial data from multiple countries and supporting the global development of innovative medicines. Companies must ensure that collaboration agreements clearly define data ownership and the allocation of responsibilities, and comply with Hong Kong’s regulatory requirements to safeguard the completeness and lawfulness of the application materials.
HONG KONG DRUG LICENSING
Does the “1+” new drug approval mechanism support registration applications for medicines developed through cross-border collaboration?
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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