What this pathway is
The measure described by the official Hong Kong and Guangdong materials concerns urgent clinical use of eligible Hong Kong-registered drugs and medical devices used in Hong Kong public hospitals. Use takes place through designated healthcare institutions in the nine mainland Greater Bay Area cities and remains subject to Guangdong approval and catalogue procedures. The catalogue measures took effect on 1 November 2025.
As at 30 April 2026, 71 drugs and 91 medical devices were approved for use in 71 designated healthcare institutions under the measure. These are official programme figures, not AsterNexis projects or outcomes.
Who may find it relevant
Teams with a relevant Hong Kong product status and a defined urgent clinical-use question may assess the measure’s current product, institution, catalogue, and approval requirements. A designated institution’s role and independent interest are essential; neither should be assumed.
What it does not provide
The measure is not nationwide Mainland China marketing authorization or general distribution permission. Use under the measure does not determine whether evidence will be accepted in a later national-registration submission. It does not guarantee catalogue inclusion, institutional engagement, approval, timing, procurement, or commercial results.
Questions to assess
- Does the product have the specific Hong Kong status described by the current measure?
- Is the proposed use an urgent clinical need within the measure’s scope?
- Which designated institution and clinical context would be relevant, subject to that institution’s interest?
- Which Guangdong catalogue, approval, procurement, use, and monitoring procedures apply?
- What activities would remain necessary for national registration or filing?
- Are the dated programme figures still current when the assessment begins?