Regional urgent clinical use
Greater Bay Area
Review the designated-institution measure for eligible Hong Kong products in the nine mainland Greater Bay Area cities.
Pathway context
What this route can—and cannot—address.
A Guangdong measure for urgent clinical use of eligible Hong Kong-registered drugs and medical devices used in Hong Kong public hospitals at designated healthcare institutions in the nine mainland cities, subject to Guangdong approval and catalogue procedures.
Boundary. Use under the Greater Bay Area measure does not equal nationwide Mainland China marketing authorization, distribution permission, or acceptance of evidence for national registration.
Last reviewed: 2 August 2026
- Geographic scope
- Designated healthcare institutions in the nine mainland cities of the Guangdong-Hong Kong-Macao Greater Bay Area.
- Eligibility context
- For the measure described here, relevant Hong Kong registration or Hong Kong public-hospital use status, urgent clinical need, designated-institution participation, and Guangdong approval and catalogue procedures.
- Primary use case
- Urgent clinical use of eligible products within designated healthcare institutions under the applicable measure.
- Institution requirement
- Use is through a designated healthcare institution that follows the applicable Guangdong application, approval, catalogue, procurement, and use controls.
- Evidence limitations
- Clinical use under the measure does not determine whether evidence will be accepted for national registration; any evidence value depends on the product and applicable NMPA requirements.
- Commercial boundary
- Use remains limited to approved products, designated institutions, the nine mainland cities, and the measure’s procedures.
- Relationship to national registration
- The measure is distinct from and does not replace the formal national registration or filing pathway.