5.1 Seeking Unapproved Drugs/Devices: The Boao Lecheng Process
The "Special Zone" Solution for Exhausted Options
The Hainan Boao Lecheng International Medical Tourism Pilot Zone is China's only legal gateway for patients to access pharmaceuticals and medical devices not yet approved for general use in mainland China. Established as a national policy experiment, it functions under "Four Specials" permissions (特许医疗). This is not a loophole; it is a highly regulated, government-sanctioned pathway for patients who have exhausted standard therapies.
The Core Mechanism: "Real-World Data" (RWD) as a Regulatory Bridge
- Application: A hospital within Lecheng applies to using a specific unapproved product for a specific patient.
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