Hainan Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as the Lecheng Pilot Zone) is a special medical zone approved by the State Council and established in 2013. The State Council and the National Development and Reform Commission, the National Medical Products Administration (NMPA), and other relevant ministries and commissions have issued for Lecheng Pilot Zone many special health-related policies on a pilot basis: to encourage the R&D and application of new medical technologies, equipment and drugs in the Lecheng Pilot Zone; to adjust the relevant laws and regulations to allow medical institutions in the Lecheng Pilot Zone to conditionally use imported drugs and medical devices that have been marketed abroad but not registered in China for urgent clinical needs; to allow the Lecheng Pilot Zone to clinical application of real-world data (RWD), the eligible real-world evidence (RWE) derived from which can be used to support the marketing authorization application of drugs and medical devices in China, among other things.
In September 2019, NMPA and the Hainan Provincial Government jointly issued the Implementation Plan for the Clinical Real-world Data Application Pilot in Hainan Boao Lecheng International Medical Tourism Pilot Zone; the nationally unique licensing policy for imported drugs and medical devices for urgent clinical needs implemented in the Lecheng Pilot Zone makes it an important pilot for national medical regulators to carry out RWD research and application. In November 2020, the Hainan Provincial Medical Products Administration, the Hainan Provincial Health Commission, and the Lecheng Pilot Zone Administration Bureau jointly established the Hainan Real-world Data Research Institute and obtained the approval from the NMPA to, based on this Institute, set up the NMPA Research Base for Drug and Medical Device Regulatory Science (hereinafter referred to as the Research Base). The Research Base will mainly take on research on the systems and mechanisms of drug and medical device regulatory science, research on clinical real-world standards and norms and consultation on relevant policies and regulations, and consultation on policies and regulations concerning the specially licensed access to imported drugs and medical devices in urgent clinical need, and it will also participate in academic exchanges and conferences, international exchanges and cooperation, etc. Academician Luo Qingming, President of Hainan University, acts as the Honorary President of the Institute; Professor Qu Jia, President of Eye Hospital, Wenzhou Medical University, and Professor Chen Pingyan, former head of the Department of Biostatistics of Southern Medical University serve as the Executive President; Professor Yao Chen, Director of the Department of Biostatistics, Peking University First Hospital and Professor Sun Xin, Director of China Evidence-Based Medicine Center of West China Hospital, Sichuan University serves as Vice President. NMPA leaders came to Boao to inaugurate the base and put forward clear requirements for its path forward.
To speed up the introduction of specially licensed imported medical products and promote progress in real-world studies (RWS), the Lecheng Pilot Zone, besides the 15 medical institutions already in operation, has brought in 51 academician-led expert teams or first-class clinical specialties, such as Academician Li Lanjuan Clinical Research Center for Infectious Diseases, Academician Zheng Shusen Clinical Research Center for Hepatobiliary and Pancreatic Oncology and Academician Wang Chen Clinical Research Center for Respiratory Diseases, which now carry out treatment and research activities in the Lecheng Pilot Zone. Pursuing partnerships of joint building and mutual benefits, the Lecheng Pilot Zone seeks to strengthen cooperation and exchanges with the Peking University Health Science Center, West China Hospital, Southern Medical University, Beijing Children’s Hospital of Capital Medical University, Hainan University, Wenzhou Medical University, Chinese Medical Association, Chinese Pharmacists Association, Society for Innovative Medicines, World Federation of Chinese Medicine Societies and other institutions of higher learning, academic groups and R&D institutions, in a bid to attract outstanding domestic scientific research teams to join Hainan Real-world Data Research Institute.
Since its establishment, the Research Base has made continuous efforts to build its scientific research system and attract and cultivate talents. It has established Hainan Provincial Real-world Data Platform, the first regional RWD platform built under national RWS-related guidelines in China; it has also established Hainan Real-world Data Research and Evaluation Key Laboratory, the first RWS laboratory in China, which has been accepted and approved by NMPA. Boao Research Hospital, operated jointly by Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and Hainan Provincial People’s Hospital, will conduct RWS as a national real-world clinical data research center, a national clinical medicine innovation center, and a national advanced medical technology research center. Teaming with Hainan University, the Institute has established the first master’s degree and doctoral program that is geared towards “RWD application” in China, serving as a training base of RWS high-end talents in China.
Since starting the clinical application of RWD on a pilot basis, Lecheng has made many breakthroughs. Three drugs or medical devices, namely the glaucoma drainage tube, the Catalys Precision Laser System, and pralsetinib, by virtue of RWD-aided clinical evaluation in Lecheng, have been approved by NMPA for marketing. The marketing authorization applications of four drugs or medical devices, namely OT-401 (YUTIQ), the cochlear implant, the thermal ablation catheter, Trilaciclib for injection, on the strength of RWD in Lecheng, have been accepted by NMPA. Such work on a pilot basis has attracted more than 60 world-renowned pharmaceutical companies to have in-depth cooperation with the Lecheng Pilot Zone, such as Sanofi, Pfizer, Johnson & Johnson, Medtronic, and Boston Scientific, etc. Nearly four-fifths of the world’s top 30 pharmaceutical companies have established a close cooperation relationship with the Lecheng Pilot Zone.
The Research Base brings together regulatory departments, academician teams, clinical institutions, research institutes, pharmaceutical enterprises, and social organizations, and other parties and taps into the unique policy advantages, valuable practical experience, and rich research resources in the Lecheng Pilot Zone, in a bid to increase academic recognition of domestic and international clinical RWS of medical products and have a say in international clinical RWS, contributing “Hainan wisdom” to the development of drug regulatory science and industrial innovation in China.
Address: No. 32, Kangxiang Road, Lecheng International Medical Tourism Pilot Zone, Boao, Hainan
Contacts: Huang Yao (+86-16689581991) and Zhao Yuanyuan (+86-19927522718)
Email: lechengrws@163.com
