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Hainan Boao Lecheng International Medical Tourism Pilot Zone

Overview

The Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as the "Lecheng Pilot Zone") is the only "medical special zone" in the country. It is located in Boao Town, Qionghai City, Hainan Province, adjacent to the core area of the Boao Forum for Asia. On February 28, 2013, the State Council approved the establishment of the Hainan Boao Lecheng International Medical Tourism Pilot Zone and granted it nine unique supporting policies, which can be summarized as the "Four Special Authorizations": special authorization for medical treatment, special authorization for research, special authorization for operation and special authorization for international exchange. Afterwards, upon the approval of the State Council, the National Development and Reform Commission, the Ministry of Commerce, the National Medical Products Administration and other departments successively granted Lecheng a series of additional special preferential policies.

The Lecheng Pilot Zone has always practiced the original aspiration of "serving the people's health", kept firmly in mind the three major missions of "enabling Chinese people to use the world's most advanced medicines and medical devices as soon as possible, promoting the development of China's health industry, and advancing the reform of China's medical and health undertakings", and, led by comprehensively deepening reform and opening up, has placed institutional integrated innovation in a prominent position.

Four Special Authorizations

In 2013, the State Council granted the Lecheng Pilot Zone nine unique supporting policies, which can be summarized as the "Four Special Authorizations":

• Special authorization for medical treatment (特许医疗)

• Special authorization for research (特许研究)

• Special authorization for operation (特许经营)

• Special authorization for international exchange (特许国际交流)

Afterwards, upon the approval of the State Council, the National Development and Reform Commission, the Ministry of Commerce, the National Medical Products Administration and other departments successively granted Lecheng a series of additional special preferential policies.

Reform and Innovation Milestones

From policy breakthroughs and industrial development to innovation leadership, the Lecheng Pilot Zone has created a number of national or provincial "firsts" or "uniques", achieving a breakthrough from "0" to "1" among the key parks of the Hainan Free Trade Port. It was the first in China to establish a Medical and Drug Administration, piloting the "medical + drug" two-in-one regulatory reform. It created the only full-process traceability platform for unlisted special medicines and medical devices in China, realizing real-time tracking and management of the entire process of special medicines and medical devices. It established the only bonded warehouse for special medicines and medical devices in China, greatly improving the import efficiency of special medicines and medical devices. It built the only long-term exhibition hall in China that brings together global innovative medicines and medical devices — the "Never-Ending" International Innovative Medicines and Medical Devices Exhibition — attracting 80 global innovative medicines and medical devices manufacturers from 16 countries. It created the only "Global Special Drug Insurance" in China, promoting the construction of an industrial ecosystem of "medicine, insurance and pharmaceuticals". It released the first institutional integrated innovation plan of a Hainan Free Trade Port park; and issued the first single-subject regulation of the Hainan Free Trade Port, the Regulations on the Boao Lecheng International Medical Tourism Pilot Zone, to promote the high-level reform and opening up of the Lecheng Pilot Zone through legislation and to release the policy dividends of the free trade port.

Medical Institutions and Global Cooperation

As of now, Lecheng has 17 medical institutions in operation and more than 20 under construction. The international influence of the Lecheng Pilot Zone continues to grow, attracting the attention of major multinational pharmaceutical companies, internationally renowned medical institutions, medical parks and international talent, and it is rapidly becoming a hot land for global innovation and entrepreneurship.

The world's top 30 pharmaceutical and medical device companies have all established direct cooperation with the Lecheng Pilot Zone. More than 200 kinds of innovative medicines and medical devices not yet listed in China have been introduced and used in the Lecheng Pilot Zone, basically achieving the "three synchronizations" of medical technology, equipment and medicines with the international advanced level, opening up a new situation of high-quality development, laying a solid foundation for building a new highland of opening up in the medical field and an important window of the domestic and international dual circulation, promoting the early harvest of free trade port healthcare, and better meeting the people's growing medical and health needs.

Real-World Research

Real-world research is an important part of the national drug regulatory science action plan, and is also one of the major institutional innovations of the Hainan Free Trade Port. The Lecheng Pilot Zone was the first in the country to carry out pilot work on the application of clinical real-world data, providing a "green channel" for international innovative medicines and medical devices to accelerate their entry into the Chinese market, which is of far-reaching significance to the reform of drug and medical device registration and regulation.

It established the Hainan Provincial Real-World Data Research Institute, undertaking work related to the NMPA drug and medical device regulatory science research base. It established China's first key laboratory for real-world research — the NMPA Hainan Real-World Data Research and Evaluation Key Laboratory. Combining Lecheng's actual situation, it built China's first regional platform for the collection, governance and application of real-world data. The platform has four major features: mechanism innovation, technological innovation, regulatory innovation and service innovation, and is an important practice and exploration in establishing new standards, new methods and new tools for real-world research in China. As an emerging interdisciplinary field, real-world research involves disciplines such as clinical medicine, biostatistics, and information and data. To strengthen talent cultivation, the Lecheng Pilot Zone, together with Hainan University, set up the first master's and doctoral postgraduate training program with "real-world data application" as its training goal — the only doctoral and master's degree program related to real-world research in the country — building a high-end talent cultivation base in the field of real-world research in China.

In accordance with the relevant guiding principles of the National Medical Products Administration and in light of the actual situation of real-world research in the Lecheng Pilot Zone, Lecheng built China's first regional platform for the collection, governance and application of real-world data. The platform has four major features: mechanism innovation, technological innovation, regulatory innovation and service innovation. It is an important practice and exploration in establishing new standards, new methods and new tools for real-world research in China, and is of great significance in helping to deepen the reform of China's drug and medical device review and approval system.

Approved Products and Regulatory Progress

Since the launch of the pilot work on the application of clinical real-world data in the Lecheng Pilot Zone, six pharmaceutical and medical device products — including the glaucoma drainage tube (青光眼引流管), the femtosecond laser ophthalmic treatment system (飞秒激光眼科治疗系统), the heat-steam therapy device (普拉替尼热蒸汽治疗设备), the single-use prostatic heat-steam therapy device (一次性使用前列腺热蒸汽治疗器械) and the fluocinolone acetonide intravitreal implant (氟轻松玻璃体植入剂) — have obtained registration approval from the National Medical Products Administration with the aid of Lecheng real-world data for clinical evaluation, accelerating their market launch in China. Three pharmaceutical and medical device products — Trilaciclib (trilaciclib for injection / 注射用曲拉西利), the Nucleus 7 sound processor and cochlear implants — obtained acceptance of their registration applications from the National Medical Products Administration using Lecheng real-world data. The pilot work on the application of clinical real-world data in Lecheng has laid a solid practical foundation for the National Medical Products Administration's regulatory decisions on the use of real-world data in the clinical evaluation of drugs and medical devices and for the formulation of relevant guiding principles and other regulations and standards, and has contributed Lecheng wisdom and Hainan strength to the reform of China's drug and medical device review and approval system, to accelerating the registration and approval of foreign innovative medical products in China, and to benefiting more Chinese patients.

Future Development Goals

In the Lecheng Pilot Zone amid the construction of the Hainan Free Trade Port, reform never stops and innovation never ceases. By 2025, the Lecheng Pilot Zone will achieve breakthrough progress in building a clinical medical center with advanced distinctive technologies and a base for the R&D and transformation of cutting-edge medical technologies, and will realize the "three synchronizations" of medical technology, equipment and medicines with the international advanced level. By 2030, its medical services and scientific research will reach the leading domestic level and the international advanced level, fully forming industrial clustering and brand effects, and it will be built into a world-class international medical tourism destination and a medical science and technology innovation platform.

This page is provided for general information only. Policy descriptions, institutional figures, product availability, regulatory status, eligibility, treatment plans and fees should be verified with official authorities, qualified medical institutions and physicians.