How International Patients Use the 2019 Lecheng Implementation Plan

NDRC circular Fa Gai Di Qu〔2019〕1482 frames Lecheng as a construction mandate: by 2025, aim for “three synchronizations” of technology, equipment, and drugs with international practice. What a patient can actually use is narrower—clinically urgent small-quantity imports inside the zone, qualifying clinical data that may support registration, and conditional take-home of a reasonable self-use quantity. None of it is automatic, and none of it is nationwide.

What the implementation plan set out

With State Council consent, NDRC, NHC, the National Administration of Traditional Chinese Medicine, and NMPA issued the Implementation Plan on 10 September 2019. Goals include breakthroughs by 2025 in advanced clinical centers and translation, and a world-class medical-travel destination and innovation platform by 2030.

Patient-relevant clauses: speed import review of drugs and devices in the zone; qualifying clinical-use data from clinically urgent small-quantity imports may be used in registration dossiers; extend the pilot to eligible hospitals inside the zone; conduct real-world clinical data studies.

Take-home and stay facilitation are written as “conditional”

The text says “study and issue” entry and stay measures for foreign clinicians, patients, and companions. On a patient filing/commitment basis, hospitals may conditionally allow a reasonable self-use quantity of imported drugs out of the zone, under “small quantity, personal use” rules. The plan also requires a traceability platform covering import, approval, use, and supervision.

Confirm a hospital pathway, not a slogan

Confirm a designated zone hospital, an already-approved product, and a written indication. If you hope to leave Lecheng with leftover imported medicine, follow the hospital’s filing and the then-current self-use rules. Do not assume take-home or take-out-of-Hainan is allowed. Compare city fit in Shanghai vs Hainan and Boao special access.

Real-world data for registration is not proof of your individual outcome. The plan is not a price list. Take-home and stay facilitation follow the license and the hospital’s and immigration officers’ written requirements at the time.