Opinions of the National Development and Reform Commission and the Ministry of Commerce on Several Special Measures to Support the Construction of Hainan Free Trade Port and Relax Market Access

No. 479 of the Development and Reform Commission of the State Council (2021)

People's Government of Hainan Province, relevant ministries and commissions of the State Council, and relevant directly affiliated institutions:

In accordance with the requirements of the Overall Plan for the Construction of Hainan Free Trade Port, in order to further support Hainan in building a free trade port market access system and market environment with Chinese characteristics, promote the free and convenient flow of production factors, accelerate the cultivation of international comparative advantage industries, and build a free trade port with high quality and high standards, with the approval of the Party Central Committee and the State Council, the following opinions are put forward.

1. Innovate market access methods in the field of medicine and health

(I) Support the development of Internet prescription drug sales. Establish the Hainan Electronic Prescription Center in the Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as the "Lecheng Pilot Zone") (providing third-party information services for prescription drug sales agencies). For prescription drugs marketed and sold in China, except for drugs that are clearly subject to special management in the National Drug Administration Law, all are allowed to be sold on the Internet based on the electronic prescription center, and no separate approval is required. The Hainan Electronic Prescription Center connects with Internet hospitals, Hainan medical institutions’ prescription systems, various prescription drug sales platforms, medical insurance information platforms and payment settlement institutions, and commercial insurance institutions to achieve unified collection of prescription-related information and “one-stop” handling of prescription drug purchases, information security certification, medical insurance settlement and other matters. The Hainan Electronic Prescription Center and relevant departments of Hainan Province should formulate detailed work plans, strengthen the management of high-risk drugs, and implement relevant principal responsibilities such as network security, information security, and personal privacy protection. Use blockchain, quantum information and other technologies to achieve online and offline linkage supervision, full traceability of drug flows, and secure data storage. (Leading units: National Health Commission, National Medical Products Administration, National Development and Reform Commission are responsible for their respective duties; participating units: National Medical Insurance Administration, China Banking and Insurance Regulatory Commission, State Administration of Traditional Chinese Medicine)

(II) Support the innovation and development of domestically produced high-end medical equipment in Hainan. It is encouraged that the first high-end medical equipment be produced in Hainan. For domestic large-scale medical equipment that is listed in the first major technical equipment promotion and application guidance catalog or the Class A and Class B large-scale medical equipment configuration license catalog and is produced in Hainan, the relevant documents on the first domestic equipment shall be followed. (Leading units: Ministry of Industry and Information Technology, National Health Commission, State Drug Administration; Participating units: National Development and Reform Commission)

(III) Increase support for drug market access. The Hainan Provincial People's Government optimizes the research and development, testing, production and application environment of drugs (traditional Chinese medicine, chemical drugs, and biological products), encourages domestic high-value medical consumables, national innovative drugs and traditional Chinese medicine research and development production enterprises to settle in Hainan, improves Hainan's new drug research and development financing supporting system, formulates a new drug research and development support system that matches the drug marketing license holder, and encourages domestic and foreign pharmaceutical companies and drug research and development institutions to develop various innovative drugs and improved new drugs in Hainan. Support medical institutions settled in the Lecheng Pilot Zone to conduct clinical trials in accordance with regulations. For innovative drugs that have completed Phase I-III clinical trials and obtained marketing authorization in China by pharmaceutical companies registered in Hainan, medical institutions in Hainan that meet the corresponding conditions are encouraged to use them directly in accordance with the principle of "admission as soon as it is approved", and relevant departments shall not set additional market access requirements. (Leading units: National Medical Products Administration, National Health Commission; Participating units: State Administration of Traditional Chinese Medicine, General Administration of Customs)

(IV) Comprehensively relax access restrictions for contract research organizations (CROs). The People's Government of Hainan Province shall formulate policy opinions to support the development of contract research organizations (CROs) in Hainan, support the establishment of a regional ethics center with international standards for medical research in Hainan, encourage Hainan medical institutions to cooperate with contract research organizations, and enhance the technical capabilities and quality management level of medical institutions in clinical trials. Optimize and improve the approval and filing process of traditional Chinese medicine preparations in medical institutions. Formulate relevant standards in accordance with the principles of safety and effectiveness, and carry out pilot projects for clinical trials and post-marketing evaluation of traditional Chinese medicines in Hainan. (Leading unit: National Medical Products Administration; Participating units: Ministry of Science and Technology, National Health Commission, State Administration of Traditional Chinese Medicine)

(V) Support the development of Hainan's high-end medical beauty industry. Well-known medical and cosmetic institutions are encouraged to settle in the Lecheng Pilot Zone. Medical and cosmetic institutions in the Lecheng Pilot Zone can use medical and cosmetic products listed in the United States, the European Union, Japan and other countries or regions in batches. Among them, drugs, medical devices and cosmetics that need to be registered or filed in the country should be registered or filed in accordance with the law. The Lecheng Pilot Zone can formulate incentive measures. The relevant departments of Hainan Province will study and propose a list of imported drugs, medical devices, cosmetics companies and products required for the development of the medical and cosmetic industry in the Lecheng Pilot Zone, assist relevant companies in registering, and the national drug supervision and administration department will provide support. Support high-level foreign medical and cosmetic doctors to practice medicine in Hainan for a short period of time in accordance with laws and regulations, promote the development of medical and cosmetic tourism industry, support the introduction and organization of international and professional medical and cosmetic industry exhibitions, summits and forums, and standardize the approval and supervision of medical and cosmetic institutions. (Leading units: National Health Commission, National Medical Products Administration; Participating units: Ministry of Commerce, Ministry of Culture and Tourism)

(VI) Optimize the access and development environment of all fields of transplant science. Gather various high-quality resources, promote the establishment of an international transplantation science research center, accelerate the construction of tissue banks in accordance with international leading standards, continuously improve relevant systems and work systems, and promote the application and transformation of research results of bioregenerative materials in Hainan. Optimize the access environment for various new drugs, testing reagents, genetic technologies, medical devices, etc. in the field of transplantation, smooth the market access links such as research and development, registration, production, and use, and support relevant products that meet the corresponding conditions to enter the priority or innovative approval procedures. Adopt consistent access standards for social capital-run medical institutions and public medical institutions in the approval of professional qualifications for human organ transplantation, and treat them equally. Set up an international transplantation medical rehabilitation diagnosis and treatment center in the Lecheng Pilot Zone, and connect with major medical institutions to carry out transplantation medical rehabilitation diagnosis and treatment. Eligible transplantation medical projects are included in the scope of medical insurance payment to facilitate medical insurance settlement in other places. Encourage commercial insurance institutions to explore and research transplantation diagnosis and treatment and rehabilitation-related insurance business. Encourage domestic first-class traditional Chinese medicine medical institutions to open relevant institutions in Hainan, carry out transplantation disciplines and combine Chinese and Western medicine diagnosis and treatment research, and promote the combination of health care. (Leading units: National Health Commission, National Medical Products Administration; Participating units: Ministry of Science and Technology, National Medical Insurance Administration, State Administration of Traditional Chinese Medicine, Chinese Academy of Sciences)

(VII) Establish a mixed-ownership reform fund for the development of Hainan's medical and health industry. Under the guidance of the National Development and Reform Commission, support Hainan in establishing a mixed-ownership reform fund for the development of the medical and health industry with social capital investment and market-oriented operation, and support the development of related industries. The CSRC actively supports the listing, mergers and acquisitions, and restructuring of strategic key enterprises supported by the mixed-ownership reform fund. (Leading unit: National Development and Reform Commission; Participating unit: CSRC)

II. Optimize market access and development environment in the financial sector

(VIII) Support the development of securities, insurance, funds and other industries in Hainan. Support securities, funds and other financial institutions to settle in Hainan in accordance with the law. Encourage the development of commercial insurance such as medical health and long-term care, and support the development of various forms of pension finance. (Leading units: People's Bank of China, China Banking and Insurance Regulatory Commission, and China Securities Regulatory Commission are responsible for their respective duties; Participating units: National Development and Reform Commission)

(IX) Strengthen data and information sharing, and carry out pilot projects to support the development of the entire agricultural industry chain. Select some areas in Hainan Province to carry out pilot projects, use geographic information system (GIS), satellite remote sensing technology, drone information collection technology and other information technology to obtain data on the entire agricultural industry chain, such as land and crops, and introduce third-party institutions in accordance with market principles to carry out risk assessment and credit evaluation. Encourage all kinds of financial institutions to provide financial support for the construction of the entire agricultural industry chain in accordance with the law and in compliance with regulations, in accordance with the functional positioning, agricultural development needs and market principles, combined with third-party evaluation information, and encourage insurance institutions to provide supporting agricultural insurance services. Encourage Hainan Province to drive the development of the entire industry chain of production, processing, circulation, sales, and experience in planting, breeding, and fisheries. Support Hainan Province to formulate specific implementation plans in conjunction with relevant financial institutions and third-party information service institutions, give full play to the advantages of local agricultural reclamation groups in resource integration and information integration, and form a development pattern in which third-party institutions of scientific and technological information and financial data participate, and agricultural reclamation groups, leading agricultural enterprises, and farmers work together. (Leading units: Ministry of Agriculture and Rural Affairs, National Development and Reform Commission are responsible according to the division of responsibilities; participating units: Ministry of Finance, Ministry of Natural Resources, China Banking and Insurance Regulatory Commission)

III. Promote the relaxation of access to the cultural field and prosperity and development

(X) Support the construction of Hainan International Cultural Relics and Art Trading Center. Introduce international rules for exhibitions, transactions, auctions, etc. in the art industry, establish the China Hainan International Cultural Relics and Artworks Trading Center, and provide an open, professional, convenient, and efficient international trading platform for outstanding artworks and tradable cultural relics that comply with relevant laws and regulations on cultural relics protection in countries along the Belt and Road. Encourage well-known auction institutions at home and abroad to conduct business in the trading center. Promote the reduction of transaction costs for artworks and tradable cultural relics, and form a comparative advantage in international transaction costs. Provide policy support in terms of customs clearance convenience, bonded goods supervision, warehousing and logistics, etc. (Leading units: the Central Propaganda Department, the Ministry of Culture and Tourism, the State Administration of Cultural Heritage, and the National Development and Reform Commission are responsible for their respective duties; participating units: the Ministry of Commerce, the People's Bank of China, the State-owned Assets Supervision and Administration Commission of the State Council, the General Administration of Customs, and the State Administration of Foreign Exchange)

(XI) Encourage the development of cultural performing arts industry. Support the development of cultural exchanges and cooperation along the Belt and Road, and promote the gathering of various resources such as performance, creation, capital, and technology in the high-quality cultural performing arts industry in countries along the Belt and Road and even the world to Hainan. Implement the reward and support policies for the cultural industry with international competitiveness, encourage the first application of new technologies such as 5G, VR, and AR, and provide systematic support in planning, land use, sea use, energy use, finance, and talent introduction. Optimize the approval of commercial performances, innovate the supervision methods during and after the event, give full play to the role of the performance industry association, and improve the level of industry self-discipline. Optimize the review of the business activities of entertainment venues and the content of game and amusement equipment. (Leading units: Ministry of Culture and Tourism, Central Propaganda Department; Participating units: National Development and Reform Commission, Ministry of Science and Technology, Ministry of Industry and Information Technology, Ministry of Civil Affairs, Ministry of Human Resources and Social Security, Ministry of Natural Resources, State Administration for Market Regulation, National Immigration Administration)

(XII) Encourage the development of the online game industry. Explore the decentralization of the approval authority for the pilot of domestic online games to Hainan, and support Hainan in developing the online game industry. (Leading unit: Central Propaganda Department)

(XIII) Relax the access to the cultural relics industry. Implement the informed commitment management for the approval of the establishment of cultural relics stores in Hainan. Support the establishment of market-oriented cultural relics restoration, protection and appraisal research institutions. (Leading unit: State Administration of Cultural Heritage)

IV. Promote the relaxation of access and the gathering of resources in the field of education

(XIV) Encourage colleges and universities to transform scientific research results in Hainan. Support Hainan to establish various scientific research results transformation bases in key development areas such as Lingshui International Education Pilot Zone and Lecheng Pilot Zone, and encourage college researchers to start businesses, work part-time, and transform scientific research results in Hainan in accordance with relevant national regulations. Encourage colleges and universities to participate in industrial investment funds that are in line with national strategies on the premise of ensuring normal operation and career development, and promote the transformation of scientific research results through transfer of licenses, valuation and equity, etc. (Leading units: Ministry of Education, Ministry of Science and Technology; Participating units: National Development and Reform Commission, Ministry of Finance, Ministry of Human Resources and Social Security)

(XV) Support well-known domestic universities to establish international colleges in Hainan. Support well-known domestic universities to establish international colleges in Hainan Lingshui International Education Pilot Zone or Sanya and other areas with better conditions for running schools to serve the construction of the "Belt and Road". The International College will be run on a small scale and provide high-quality undergraduate education. The disciplines and majors are mainly basic science and applied technology science and engineering disciplines. The relevant institutes of the Chinese Academy of Sciences will support the construction of the college and encourage innovative ways to carry out school cooperation and academic exchanges with internationally renowned universities. The initial enrollment scale is 300-500 people per year, and the enrollment is mainly international students. International students mainly accept applications from outstanding high school graduates and first-year university students from countries along the "Belt and Road" and are admitted on a fair basis. The Ministry of Education actively supports high-quality study abroad programs in relevant universities in Hainan Province through Chinese government scholarships and other means. The Chinese Academy of Sciences and other relevant units will work with Hainan Province to formulate specific construction plans and implement them after approval according to procedures. (Leading units: Chinese Academy of Sciences, Ministry of Education; Participating units: National Development and Reform Commission, Ministry of Foreign Affairs, National Immigration Administration)

(XVI) Encourage Hainan to vigorously develop vocational education. Improve the vocational education and training system, deepen the integration of production and education, and school-enterprise cooperation, and encourage social forces to organize vocational education through sole proprietorship, joint ventures, cooperation and other forms. Support Hainan in building a public vocational skills training base that serves the national regional development strategy. Hainan is encouraged to vigorously develop vocational education in the fields of medical care, health care, cultural performances, and cultural relics restoration and appraisal. The establishment, change and termination approval of private schools that only implement vocational skills training, as well as the establishment approval of technical schools, shall be subject to informed commitment management. (Leading units: Ministry of Education, Ministry of Human Resources and Social Security, National Development and Reform Commission)

V. Relax market access in other key areas

(XVII) Optimize the market access environment in Hainan's commercial aerospace sector and promote high-quality development. Support the construction of an integrated and open Wenchang Space Launch Site, create a world-class, market-oriented space launch site system, coordinate the construction of related measurement and control systems, ground systems, and application systems, and establish a construction management and application model that conforms to the development characteristics of my country's international commercial aerospace industry. Promote the landing of commercial aerospace industry chains such as satellite remote sensing, Beidou navigation, satellite communications, quantum satellites, chip design, launch vehicles, and measurement and control in Hainan. Optimize the procedures for handling matters such as space launch declaration and space launch site coordination, and enhance the safety supervision capabilities of activities such as the production, storage, transportation and testing of launch vehicles, engines and related products. Support the demonstration of Beidou navigation international applications in Hainan. Support the establishment of a mixed-ownership reform fund for commercial aerospace development funded by social capital and operated in a market-oriented manner. Encourage insurance institutions to carry out aerospace-related insurance business under the premise of compliance with laws and regulations and controllable risks. Support international cooperation in the field of commercial satellites and payloads, and encourage the development of international collaborative development, application and data sharing services for satellite data. Optimize the approval procedures for international cooperation in the fields of technology research and development, engineering development, system operation, and application promotion in the field of commercial aerospace. Formulate special preferential policies to attract high-end talents and innovation teams in the field of international commercial aerospace to settle down, and establish an international exchange and training platform. (Leading units: State Administration of Science, Technology and Industry for National Defense, National Development and Reform Commission and other units are responsible for the division of responsibilities; participating units: Ministry of Science and Technology, Ministry of Industry and Information Technology, Ministry of Natural Resources, Ministry of Transport, Ministry of Commerce, China Banking and Insurance Regulatory Commission)

(XVIII) Relax access to the civil aviation industry. Optimize the management mode of Hainan civil airports, optimize the use permit of civil aviation security equipment, and simplify the approval process for planning and application for construction of general aviation airports. In the field of general aviation, explore the establishment of a hierarchical and classified personnel qualification management mechanism and an aircraft airworthiness technical standard system, simplify the approval process for flight training centers, civil aircraft pilot schools, and flight dispatcher training institutions, and minimize the entry threshold while meeting safety and technical requirements. Support the application of new technologies such as 5G civil aviation safety communications, Beidou, and broadcast automatic surveillance in the fields of air traffic management and flight service support. Implement financial, fiscal, taxation, and talent policy support, and encourage social capital to invest in general aviation, aviation fuel support, aircraft maintenance services, and other fields. (Leading units: Civil Aviation Administration of China, National Development and Reform Commission; Participating units: Industry and