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How open is China's medical sector in Boao? Global pharmaceuticals and medical devices directly reaching patients
Release time:
2025-03-12 09:41
More than 10 well-known multinational pharmaceutical and medical device manufacturers have written letters seeking cooperation. The first imported medical device in China to be approved for listing using real-world data from Boao Lecheng has been launched, and the nation's first medical insurance plan covering special domestic and foreign drugs has been implemented. Despite the pandemic, the Boao Lecheng International Medical Tourism Pilot Zone in Hainan continues to make progress, continuously expanding China's medical opening-up window.
Global pharmaceuticals and medical devices directly reach patients, who can simultaneously enjoy international new drugs.
The pilot zone's special policies allow patients to simultaneously use the latest drugs that have already been launched in developed countries such as Europe and the United States but have not yet been approved for import in China.DrugsBy the end of March this year, the pilot zone had approved the import of 64 varieties of urgently needed imported clinical drugs in 63 batches.Medical devicesThe average approval time for each batch of imported drugs is only 1.8 working days, and they have been used for 285 patients, achieving good clinical results.
"In the pilot zone, the import, registration, and approval of new drugs, devices, and vaccines not yet on the market in China are very fast, and there are also import tariff concessions." Liu Zhefeng, deputy director of the pilot zone's administrative bureau, introduced that patients can also take small amounts of urgently needed imported oral drugs for their own use out of the pilot zone.
Over the past two years, the pilot zone has completed the world's most careful cardiac pacemaker clinical market implantation surgery, fully visible and magnetic-electric dual-positioning heart surgery, minimally invasive glaucoma drainage tube surgery, and authorized cochlear implant surgery, creating several national firsts.
"From application to approval and use, it only took 3 days. Now, my eyesight has recovered very well." Ms. Lin, the first patient in mainland China to use a scleral lens, told reporters that the product has been used in European and American countries but has not yet been approved for listing in China. However, in the pilot zone, she can enjoy the latest international treatment without leaving the country.
Pilot program for real-world data applications, green channel for imported pharmaceuticals and medical devices
During the outbreak of the domestic epidemic, 11 globally renowned multinational pharmaceutical and medical device manufacturers, including Pfizer, Astellas, and Merck, sent letters to the pilot zone, expressing their strong confidence in the future development of the pilot zone and their willingness to continue in-depth cooperation.
Many foreign pharmaceutical companies are eyeing China's huge consumer market, and the pilot zone is a shortcut to entering this market. The policy of "allowing the application of real-world clinical data in the pilot zone" has opened up a green channel for imported pharmaceuticals and medical devices to be listed in China.
According to the traditional clinical trial path, the cost of new drug development is high, the time is long, and the success rate is low. There is a saying among pharmaceutical companies that "it takes 10 years and US$1 billion to develop a new drug." Using data collected from daily medical processes, namely real-world data to support review, can significantly reduce research and development costs and speed up approval for listing.
In January this year, the pilot zone signed a strategic cooperation agreement with Boston Scientific to carry out multi-faceted cooperation in the field of real-world data applications and accelerate the listing of innovative global medical devices in China.
"Policy dividends are further released, and the pilot zone has become a multinationalenterprisethe best place for innovation practices in China." Zhang Jun, vice president and general manager of Greater China at Boston Scientific, said.
Currently, three products in the pilot zone have launched real-world data application research, including Johnson & Johnson's femtosecond product for cataract treatment, Allergan's drainage tube for glaucoma treatment, and Cochlear's NG sound processor. The actual usage data of these pilot products in the pilot zone will be used as formal clinical data to apply to the National Medical Products Administration for drug listing permits. Among them, the glaucoma drainage tube has become the first product in China to be approved for listing using real-world data from Lecheng.
"Deregulation, streamlining administration, and improving services" reforms continue to deepen, and medical opening-up pursues higher
From "simplified approval" to "two certificates and one batch," realizing "first warehousing, then inspection" for special-licensed drugs... The continuously deepening "deregulation, streamlining administration, and improving services" reforms have pushed the pilot zone's medical opening-up to higher levels.
The pilot zone has opened up a fast-track approval channel for imported special-licensed pharmaceuticals and medical devices, compressing the approval time from the original six months to one to three working days. The time difference between imported special-licensed pharmaceuticals and medical devices and their overseas listing has been significantly shortened. Cardiac contractility regulators and cosmetic injection gels, which have only been on the market in Europe and the United States for less than half a year, have been simultaneously applied in the pilot zone.
"When there is an urgent need for medication, if you need it tomorrow, we will hold a meeting tonight to approve it for you." Liu Zhefeng said that the pilot zone has established a public bonded warehouse, purchasing and storing corresponding pharmaceuticals and medical devices in advance as needed, and establishing an information platform to ensure that the source of special drugs can be traced, their destination can be verified, their behavior can be recorded, and responsibility can be pursued. Since February this year, online paperless approval has been implemented, making the process more convenient.
The pilot zone has currently introduced 51 academician and expert teams, and the gathering of high-end medical talents benefits from the innovative "1+X" shared platform model.Hospitaloperation and management system. Li Lanjuan, president of Boao Super Hospital, said that through the cluster medical model, exploring effective paths for China's medical reform, the hospital is like an airport, building nests to attract phoenixes, and the medical teams that move in are like various airlines. Patients, hospitals, and medical teams rely on each other and purchase services from each other.
The open medical system drives the simultaneous development of production, education, and research. The University of Edinburgh in the UK will cooperate with Shanghai Jiao Tong University to establish a Sino-foreign cooperative medical college with independent legal person status in Lecheng, attracting a large number of international students and a continuous stream of researchers and clinicians.
"The pilot zone is a highly professional medical industrial park, and its high-quality development depends ontalentsupport." Gu Gang, director of the pilot zone's administrative bureau, said that by giving full play to the talent advantages brought by the gathering of experts and the resource advantages brought by the application of special-licensed pharmaceuticals and medical devices, the "1+X" model will transform characteristic departments into super-specialty hospitals, making them medical destinations that solve patients' ailments.
Boao, multinational, pharmaceuticals and medical devices
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