Regional special access
Boao Lecheng
Review the institution-led, product-specific clinical-use pathway and the limits of real-world evidence within Boao Lecheng.
Pathway context
What this route can—and cannot—address.
A controlled route for selected overseas-approved innovative drugs and medical devices to be used for specific clinical needs through qualified medical institutions in the pilot zone, subject to official procedures.
Boundary. Lecheng special access is product-, institution-, and purpose-specific. It does not equal Mainland China marketing authorization or general commercial distribution permission.
Last reviewed: 2 August 2026
- Geographic scope
- Qualified medical institutions in the Boao Lecheng pilot zone in Hainan.
- Eligibility context
- Overseas product status, a defined clinical need, a qualified medical-institution application, and review under the applicable official procedure.
- Primary use case
- Controlled use for a specific clinical need within the permitted institutional and product scope.
- Institution requirement
- A qualified medical institution is the applying and responsible use entity and must follow the relevant application, use, monitoring, and traceability requirements.
- Evidence limitations
- For an eligible product, scientifically designed research using fit-for-purpose, quality-controlled RWD may generate RWE that supports clinical evaluation alongside the wider evidence package.
- Commercial boundary
- Permission is tied to the approved product, institution, purpose, and use conditions; it is not general Mainland commercialization permission.
- Relationship to national registration
- Lecheng use and RWE may inform a national strategy, but neither replaces the applicable NMPA registration review.
Primary material
Official sources
- Hainan MPA application guide for clinically needed imported drugs and medical devices
- Hainan MPA 2026 notice on supervision of clinically needed imported drugs and medical devices
- Hainan MPA permitted-use boundary document (PDF)
- Hainan MPA 2026 real-world data application guide
- Hainan MPA interpretation of the 2026 real-world data guide
- NMPA overview of the Lecheng real-world data pilot