Xinhua News Agency, Haikou, April 6th, Question: How high is the opening of China's medical care in Boao?

Xinhua News Agency reporter Yan Yujing

More than 10 well-known multinational pharmaceutical equipment manufacturers sent a letter to "for cooperation", the first domestic imported device using Lecheng's real-world data was approved for listing, and the country's first domestic and overseas special drug cost-compensated medical insurance landed ... Under the epidemic, Hainan Boao The Lecheng International Medical Tourism Pioneer District keeps pace, and it continues to promote the opening of China's medical open window.

Global medical equipment reaches patients directly, and enjoys international new drugs simultaneously

The licensing policy of the Pioneer Zone allows patients to use the latest drugs that have been listed in developed countries such as Europe and the United States, but have not yet been approved for import in China. As of the end of March this year, 63 batches of 64 kinds of urgently needed imported drugs and medical devices have been approved for import in the Pioneer District. The average approval time for each batch of imported drugs is only 1.8 working days. It has been used in 285 patients and achieved good clinical results. .

"In the pioneer zone, the use of domestic unlisted new drugs, new devices, new vaccines, import, registration and approval are very fast, and import tariffs are also preferential." Liu Zhefeng, deputy director of the pioneer zone administration, said that patients can also be used only For self-use, a small amount of oral clinics urgently need to take imported drugs away from the leading area.

In the past two years, the Pioneer District has completed the clinical market implantation of the world ’s smallest cardiac pacemaker, full-length visual and magnetic-electric dual-position cardiac surgery, glaucoma drainage tube minimally invasive surgery, and chartered cochlear implantation. The first case.

"From application to approval and use, it took only 3 days before and after. Now, my vision is recovering very well." Ms. Lin, the first patient in China who used scleroscope, told reporters that the product has been used in European and American countries. It has not yet been approved for listing, but it can enjoy the latest international treatment simultaneously without going abroad in the Pioneer Zone.

Pilot application of real-world data, green channel for the import of imported pharmaceutical equipment

During the outbreak of domestic outbreaks, Pfizer, Astellas, Merck, and other 11 world-renowned multinational pharmaceutical equipment manufacturers have written to the Pioneer Area, expressing their firm belief in the future development of the Pioneer Area and their willingness to continue in-depth cooperation.

Many foreign pharmaceutical companies are looking at China's huge consumer market, and the pioneer zone is a shortcut to enter this market. The policy of “allowing real-world clinical data applications to be carried out in the Pioneer Zone” has opened up a green channel for imported pharmaceutical equipment to be listed in China.

According to the traditional clinical trial path, new drug development costs are high, the time is long, and the success rate is low. There is a saying among drug companies that "a new drug is developed for 10 years and costs 1 billion US dollars." The use of the data collected in the daily medical process, that is, real-world data to support the review, can greatly save R & D costs and be quickly approved for listing.

In January of this year, the Pioneer District and Boston Scientific signed a strategic cooperation agreement to conduct multi-faceted cooperation in the field of real-world data applications to accelerate the launch of global medical device innovation products in China.

"The policy dividend is further released, and the pioneer zone has become the best place for multinational companies to innovate in China," said Zhang Jun, vice president of Boston Scientific and general manager of Greater China.

Currently, there are three products in the Pioneer District that are conducting real-world data application research, including Johnson & Johnson ’s femtosecond product for cataract treatment, Ai Jian ’s drainage tube for glaucoma and Collier ’s NG sound processor. The actual use data of these pilot products in the pilot area will be used as official clinical data to apply for drug marketing approval to the State Food and Drug Administration. Among them, glaucoma drainage tube has become China's first product approved for listing using Lecheng's real-world data.

"Release of service" reform continues to deepen, medical openness pursues higher

From "Minimal Approval" to "Two Licenses and One Batch", to achieve the "first warehouse, then inspection" of licensed drugs ... The continuous deepening of the "delegation of service" reform, promoting the opening of the medical area in the pioneer area is getting higher and higher.

The Pioneer District has opened up a fast track for the approval of imported licensed medical devices, and the time for the approval of imported licensed medical devices has been reduced from the original six months to 1 to 3 working days. The time difference between the import of licensed medical equipment and the time to market abroad has been greatly shortened. Cardiac contractility regulators, cosmetic injection gels, etc. have only been marketed in Europe and the United States for less than half a year, and have been applied synchronously in the leading areas.

"When there is an urgent need for medication, you want it tomorrow, and we will hold a meeting tonight to approve it for you." Liu Zhefeng said that the pioneer zone has established a public bonded warehouse, purchased and reserved the corresponding medical equipment in advance, and established an information platform to realize special drugs The source can be traced, the destination can be verified, the behavior can be traced, and the responsibility can be investigated. Since February this year, online paperless approval has been achieved, and the process is more convenient.

The Pioneer District currently introduces 51 contracted academicians and expert teams. The gathering of high-end medical talents has benefited from the innovative "1 + X" shared platform model hospital operation and management system. Li Lanjuan, president of the Boao Super Hospital, said that through the cluster-based medical model, exploring the effective path of China's medical reform, the hospital is equivalent to an airport, nesting and phoenix, the medical team stationed is equivalent to each airline, patient and hospital, hospital and medical The teams rely on each other and buy services from each other.

The open medical system promotes the simultaneous development of industry, academia and research. The University of Edinburgh in the UK will cooperate with Shanghai Jiaotong University to establish an independent legal person Sino-foreign cooperative medical school in Lecheng, attracting a large number of international students and a steady stream of researchers and clinicians.

"The Pioneer District is a highly specialized medical industrial park, and its high-quality development is inseparable from the support of talents." Gu Gang, director of the Pioneer District Administration, said that the talent advantage brought by the concentration of experts and the resource advantage brought by the application of licensed medical equipment were used Through the "1 + X" model, the special departments are transformed into super specialty hospitals, making them a medical destination for patients' pain.