How Lecheng cut the wait for unapproved drugs and devices from months to days

Boao Lecheng, Hainan's international medical tourism pilot zone, has for years been allowed to use drugs and devices approved abroad but not yet registered with China's national regulator, provided a specific patient's case justified the import. That patient-bound model was also the bottleneck: reviewing an unregistered product's overseas approval file, trial data and manufacturing standards from scratch typically took 60 to 200 days, timed to a single patient who was, by definition, already waiting.

The fix: decouple the product review from the patient

A measure jointly issued on 24 March 2026 by Hainan's drug administration, health commission and the Lecheng authority created a standing "pre-review pool" (预审查库). Hospitals, the China-incorporated subsidiaries of overseas marketing-authorisation holders, and licensed agents can now submit a product's technical file before any patient is attached to it. Hainan's health commission confirms clinical necessity within 3 working days; the drug administration completes the safety and quality review within 7. Once a product clears this stage, it sits in the pool ready to use.

When an actual patient later needs that product, the treating hospital's individual-case application skips the technical review entirely, since the underlying file was already vetted, and only needs to confirm the patient's own diagnosis and the treating team's qualifications. Hainan reports this cuts individual case approval to 3 to 7 days.

What qualifies for the pool

• Drugs already approved in an ICH member jurisdiction, or devices approved in an IMDRF member jurisdiction.
• Products treating rare diseases or life-threatening conditions with no adequate domestic alternative.
• Products intended to generate real-world data supporting a future formal China registration.

A bonded-warehouse mechanism runs alongside the approval change: once a product is in the pool, licensed distributors can stock it in Hainan's free-trade-port bonded warehouses ahead of demand, so approved supply reaches a hospital pharmacy in 1 to 2 days rather than waiting on international air freight after the fact. Products exit the pool automatically if they gain full national approval, lose their overseas licence, or trigger a safety signal, so inclusion is not a permanent exemption.

As of mid-2026, Hainan reports roughly 580 licensed products approved for first use in China through this route, serving close to 300,000 patients. For a patient evaluating Lecheng, the practical question to ask a prospective hospital is not "can Lecheng use this drug" in the abstract, but whether the specific product is already in the pre-review pool, which is what determines whether the wait is measured in days or months.

Written by Paperwork First. General information, not legal, immigration or medical advice; policies and prices move, and the issuing authority's current text prevails.

← All posts