Early Access Drugs at Lecheng: FDA-Approved Treatments in China
One of the most significant advantages of Boao Lecheng is the ability to access medicines and medical devices that have been approved by international regulatory bodies but are not yet available in mainland China.
How It Works
Medical institutions in Lecheng can import and use:
- FDA-approved (United States) drugs and devices
- EMA-approved (European Union) products
- PMDA-approved (Japan) medications
These products can be used for patients in the zone before obtaining NMPA (China's drug regulator) approval.
What's Available
As of 2025, the zone has introduced more than 485 innovative medicines and medical devices, including:
- Cancer immunotherapy drugs (checkpoint inhibitors)
- Rare disease treatments
- Advanced medical devices
- Special medical formula foods (first in China, February 2025)
Key Policy Details
- Zero-tariff: No import duties on medical products
- Cost savings: ¥62 million saved in duties (Dec 2024 - End 2025)
- Fast-track access: Streamlined approval for clinical urgency
Patient Eligibility
To access early drugs at Lecheng:
- Have a documented medical need
- Receive treatment at a participating institution
- Sign informed consent for pre-approval drugs
- Comply with monitoring requirements
Conclusion
For patients who have exhausted standard treatment options, Lecheng offers hope through access to the latest global medical innovations.
