“Boao Hope City” allows overseas drugs and medical devices that have not been approved in China but approved overseas to be sold and used in real-world clinical settings in Hainan Province. Moreover, the Clinical Real-World Data of the overseas drugs and medical devices can be collected to support the regulatory approval by China National Medical Products Administration (NMPA). The preferential policies have simplified the approval process of clinically urgently needed drugs and medical devices and have provided a fast-tracked pathway into China's pharma and medtech industry. Up to date, nearly 200 drugs and medical devices have been imported to Hainan. This is particularly significant for Swiss healthcare companies providing high-value and innovative drugs and medical devices that normally require clinical trials by China NMPA.
Our factsheet will provide you with detailed information on the following topics:
- Hainan (an overview)
- “Boao Hope City” (an overview)
- Preferential policies
- Fast approval for use within the Pilot Zone
- Real-World Data/Study (RWD) Pilot Program as a fast-tracked pathway to sell nationwide in China
- Solutions, Products and Services in Demand
- Designated Medical Institutes
- Designated Distributors
- Application and Approval Process
- Case studies
