Daxue: Medical institutions within the zone can import and use pharmaceuticals and medical devices already available in other countries as clinically urgent items before obtaining approval in China. This allows domestic patients to access innovative treatments without the need to travel abroad…. The medical products to be used in the pilot zone must possess a CE mark, an FDA license, or PMDA approval, which respectively indicate that they have been approved in the European Union, the US, and Japan for their safe and effective use.
Moreover, evidence on the new drugs and devices used within the zone can be used to support approval from the Chinese FDA–this seems to work similar to Bartley Madden’s dual track procedure.
Daxue: Since 2020, the National Medical Products Administration has introduced regulations on real-world evidence (RWE), with the pilot zone being the exclusive RWE pilot in China. This means that clinical data from licensed items used within the zone can be transformed into RWE for registration and approval in China. Consequently, medical institutions in the zone possess added leverage in negotiations with international pharmaceutical and medical device manufacturers seeking to enter the Chinese market.
… This process significantly reduces the time required for approval to just a few months, saving businesses three to five years compared to traditional registration methods. As of March 2024, 30 medical devices and drugs have been through this process, among which 13 have obtained approval for being sold in China.
Boao Hope City, officially known as the Hainan Boao Lecheng International Medical Tourism Pilot Zone, is a groundbreaking initiative in China’s healthcare and tourism sectors. Established in 2013 with approval from China’s State Council, this unique pilot zone is located in Hainan Province, China’s southernmost tropical island.
The pilot zone spans over 20 kilometers and aims to develop a world-class medical tourism destination and medical technology innovation center by 2030. It focuses on four key sectors: medical treatment, medical cosmetology, rehabilitation, and health promotion. The zone’s primary goal is to provide high-quality medical tourism-related services to visitors from both domestic and international markets.
Boao Hope City enjoys several exclusive favorable policies that set it apart from other medical facilities in China. It is allowed to introduce new and innovative medicines, medical devices, and technologies that have been approved overseas but not yet in mainland China. Since 2020, it has been designated as the exclusive Real-World Evidence (RWE) pilot in China, allowing clinical data from licensed items used within the zone to be transformed into RWE for registration and approval in China. In April 2021, the first e-prescription center in China was established in Lecheng, facilitating the sale of prescription drugs through the internet. Additionally, a trailblazing drug insurance program was launched in 2020, covering foreign medicines not yet approved domestically.
The pilot zone has attracted numerous international medical institutions and pharmaceutical companies. As of 2023, it hosts 26 medical institutions, including renowned names from various countries. The zone has also fostered collaborations with global pharmaceutical companies, creating opportunities for innovative medicines and medical devices to enter the Chinese market more rapidly.
Boao Hope City has seen significant growth in medical tourism. In 2022, the zone welcomed 189,000 medical tourists, a substantial increase from previous years. The pilot zone benefits from Hainan’s special visa policy, allowing tourists from 59 countries to stay for up to 30 days without a visa, making it more accessible for international medical tourists.
As part of the broader Hainan Free Trade Port initiative, Boao Hope City is positioned to play a crucial role in China’s healthcare and tourism sectors. The zone aims to accommodate 200,000 visitors annually by the end of 2024, driving substantial revenue growth. Furthermore, it continues to attract international investment and foster innovation in medical treatments and technologies.
In conclusion, the Boao Hope Lecheng Medical Tourism Pilot Zone represents a bold step in China’s efforts to integrate healthcare, tourism, and technological innovation. By offering unique policies, cutting-edge treatments, and a welcoming environment for both domestic and international visitors, Boao Hope City is poised to become a leading destination for medical tourism and a hub for medical innovation in Asia.
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