Recently, scleral lenses produced by Valley Contax, an American custom contact lens manufacturer, were approved for the domestic market by China’s National Medical Products Administration, becoming the latest new pharmaceutical device launched through real world research at the Lecheng International Medical Tourism Pilot Zone in south China’s Hainan Province.
The scope of Lecheng’s real-world data application pilot is continuing to expand, and now covers a wide variety of fields including oncology, immunity, and ophthalmology. Thirteen urgently needed imported pharmaceutical and medical devices have been approved for use in China through real-world data from Lecheng, which was used in clinical evaluation.
It’s usually a long process for medications from outside China to be approved for use inside the country. They must first complete phase three clinical trials to test the effectiveness and safety of the medication for the local population. This can take anywhere from 3-5 or even 8-9 years, which is quite a long time for patients to wait and can involve staggering investment costs by the time new medications are finally approved for sale on the Chinese market.
In 2019, China’s National Medical Products Administration and the Hainan Provincial People’s Government jointly launched the clinical real-world data application pilot project in Lecheng, located in Bo’ao, Hainan. The pilot program explores the use of clinical real-world data for medication and medical device product registration and regulatory decisions, accelerating the approval process for innovative medications and medical devices entering the domestic market and greatly benefiting local patients.
Thanks to these special policies, innovative medical devices from outside the Chinese mainland can be imported and used under a special licence in Lecheng, allowing patients access to urgently needed care. The data generated through these trials provides the basis for real-world research. According to Hainan Institute of Real World Data Executive Director Chen Pingyan, after data analysis and sorting is carried out, the results are used for applications to licence international medications and medical devices for use on the domestic market.
For example, under the normal application process, the innovative fluocinolone acetonide intravitreal implant may have become available to Chinese patients only at the end of 2023. However, on June 16, 2022, after evaluation of overseas clinical trial data and domestic patient real-world clinical data, it was approved for domestic use, shortening the application process by around a year and a half.
The average approval time for the 13 products that have already come onto the Chinese market thanks to data from the pilot program is around 8 months, with one product being approved after only a record six months.
In order to encourage more real-world research, China established a scientific research base for medicine and medical device supervision in 2020, as well as a key laboratory for real-world data research and evaluation in 2021 in Lecheng. China’s first regional real-world data platform was also set up in Hainan at that time, providing robust technical support allowing Lecheng to efficiently carry out real-world research.
As an emerging interdisciplinary field, real-world research also requires top-tier talent. Luo Qingming, President of Hainan University, remarked that the university opened China’s first interdisciplinary "Real World Data Application" master's and doctoral training programs in collaboration with the Hainan Institute of Real World Data. There are currently 24 master’s degree and 15 doctoral students enrolled in these new majors.
Innovative platforms, high-level talent, and high-quality services allow real-world research to come to fruition in Lecheng, while also bringing more companies engaged in real-world research to the area. There are now 26 medical institutions in the International Medical Tourism Pilot Zone, and more than 20 are currently under construction or making preparations to open. Lecheng has established in-depth cooperative relationships with more than 170 pharmaceutical and medical device companies in 20 countries and regions.
The application of real-world data has achieved excellent initial results in many fields, but overall this practice is still in the very early stages, with much more research and exploration needed. Lecheng is setting up a platform for the transformation of the medical industry, a real-world research platform, an international multi-center medicine and medical device clinical trial platform, a health and cultural industry innovation platform, and an investment service platform. "These five platforms cover multiple links in the biopharmaceutical industry chain, and global innovative pharmaceutical and medical device companies have access to one-stop services here," said Jia Ning, Director of the Lecheng International Medical Tourism Pilot Zone Administration. Director Jia stated that Lecheng not only provides a channel for international innovative pharmaceutical devices to accelerate entry to the Chinese market, but also a practical way for China to establish new standards, new methods, and new tools for real-world research.
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