Opinions of the National Development and Reform Commission on Innovating Market Access in Medicine and Health Sectors in the Hainan Free Trade Port.
(I) Supporting online sales of prescription drugs.
The Hainan Electronic Prescription Centre (providing third-party information services for sales agencies of prescription drugs) will be established in Bo’ao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as "Lecheng Pilot Zone").
The prescription drugs sold on the market in China, except for those subject to special administration as stipulated in the Drug Administration Law of the People's Republic of China, are allowed to be sold online by relying on the Hainan Electronic Prescription Centre, without separate approval.
The Hainan Electronic Prescription Centre connects with online hospitals, prescription systems of medical institutions in Hainan, sales platforms for prescription drugs, the medical insurance information platform, payment and settlement agencies, and commercial insurance agencies, to realize the unified collection of prescription-related information and the handling via a single website of such matters as prescription drug purchase, information security certification, and medical insurance settlement.
The Hainan Electronic Prescription Centre and the relevant departments of Hainan Province shall formulate detailed work plans, strengthen the administration of high-risk drugs, and fulfil the primary responsibilities such as cyber security, information security, and personal privacy protection.
Block chain, quantum information and other technologies are to be used to realize online and offline linked supervision, whole-process traceability of drug flows, and secure data storage.
(Led by: National Health Commission, National Medical Products Administration, and National Development and Reform Commission as per the division of responsibilities; participated in by: National Healthcare Security Administration, China Banking and Insurance Regulatory Commission, and National Administration of Traditional Chinese Medicine)
(II) Supporting the innovative development of China-made high-end medical equipment in Hainan.
The first (set of) high-end medical equipment is encouraged to be produced in Hainan.
China-made large medical equipment produced in Hainan and included in the guiding catalogue for promotion and application of the first (set of) major technical equipment or the catalogue for allocation licensing for Category A and Category B large medical equipment shall be subject to the requirements of the relevant document on the first (set of) China-made equipment.
(Led by: Ministry of Industry and Information Technology, National Health Commission, and National Medical Products Administration; participated in by: National Development and Reform Commission)
(III) Increasing support for access to the medicine market.
The People's Government of Hainan Province needs to optimize the environment for research and development, testing, production, and application of medicine (traditional Chinese medicine, chemical medicine, and biological products), encourage enterprises engaged in research, development and production of China-made high-value medical consumables, national innovative drugs and traditional Chinese medicine to settle in Hainan, improve Hainan's financing system for research and development of new drugs, formulate a support system for research and development of new drugs that matches with drug marketing authorization holders, and motivate domestic and foreign pharmaceutical companies and drug research and development institutions to develop innovative drugs and improved new drugs in Hainan.
Medical institutions settled in Lecheng Pilot Zone are supported to carry out clinical trials in accordance with the provisions.
Medical institutions in Hainan that meet the appropriate conditions are encouraged to directly use, in line with the principle of "import upon approval", the innovative drugs for which pharmaceutical companies registered in Hainan have completed Phase I-III clinical trials in China and obtained the marketing authorization, and the relevant government agencies shall not set additional requirements for market access.
(Led by: National Medical Products Administration, and National Health Commission; participated in by: National Administration of Traditional Chinese Medicine, and General Administration of Customs)
(IV) Fully relaxing access restrictions on contract research organizations (CROs).
The People's Government of Hainan Province shall formulate the policies and opinions on supporting CROs to settle in Hainan, provide support for the establishment of a regional ethics centre for international standards for medical research in Hainan, encourage Hainan's medical institutions to cooperate with CROs, and improve the technical capability for clinical trials and quality management of medical institutions.
The approval and record-filing procedures for traditional Chinese medicine preparations of medical institutions shall be optimized and improved.
The relevant standards shall be formulated in accordance with the principles of safety and effectiveness, and the pilot program of clinical trial and re-evaluation after marketing of traditional Chinese medicine shall be carried out in Hainan.
(Led by: National Medical Products Administration; participated in by: Ministry of Science and Technology, National Health Commission, and National Administration of Traditional Chinese Medicine)
(V) Supporting the development of Hainan's high-end medical cosmetology industry.
Well-known medical cosmetology institutions are encouraged to settle in Lecheng Pilot Zone.
The medical cosmetology institutions in Lecheng Pilot Zone may use in batches the medical cosmetology products marketed in the United States, the European Union, Japan and other countries or regions.
Among them, drugs, medical devices and cosmetics that need to be registered or filed in China shall be registered or filed in accordance with the law. Lecheng Pilot Zone may formulate incentive measures.
The relevant government departments of Hainan Province shall research and put forward the list of imported drugs, medical devices, cosmetics companies and products required for the development of the medical cosmetology industry in Lecheng Pilot Zone, and assist the related companies in handling the registration, under the support of the national medical products administration.
Foreign high-level medical cosmetologists are supported to practice medicine in Hainan for a short period of time in accordance with laws and regulations. The development of the medical cosmetology tourism industry shall be promoted.
Support is given to the introduction and organization of international and professional exhibitions, summits, and forums in the medical cosmetology industry.
The approval and regulation of medical cosmetology institutions shall be standardized. (Led by: National Health Commission, and National Medical Products Administration; participated in by: Ministry of Commerce, and Ministry of Culture and Tourism)
(VI) Optimizing the market access and development environment for all fields of transplantation science.
It is imperative to gather all kinds of high-quality resources, promote the establishment of an international transplantation science research centre, accelerate the construction of a tissue bank in accordance with international leading standards, continuously improve related systems and work systems, and boost the application and transformation of research results related to renewable biological materials in Hainan.
Efforts will be made to optimize the market access for all kinds of new drugs, inspection and testing reagents, genetic technologies, and medical devices in the transplantation field, ensure smooth market access links such as research and development, registration, production, and use, and support related products that meet the corresponding conditions to enter priority or innovative approval procedures.
Medical institutions run by social capital and public medical institutions shall be subject to consistent access standards in terms of the identification and approval of practicing qualifications for human organ transplantation, and be treated equally.
An International medical transplantation, rehabilitation, diagnosis and treatment centre will be built in Lecheng Pilot Zone to carry out medical transplantation, rehabilitation, diagnosis and treatment in cooperation with major medical institutions.
Eligible medical transplantation projects shall be included in the scope of medical insurance payment, and the medical insurance settlement in different places shall be facilitated.
Commercial insurance institutions are encouraged to explore and research insurance business related to transplantation diagnosis, treatment and rehabilitation.
Domestic first-class traditional Chinese medicine institutions are encouraged to set up the relevant institutions in Hainan, carry out research on integration of traditional Chinese medicine and Western medicine in diagnosis and treatment in the transplantation discipline, and promote the integration of health and aged care services.
(Led by: National Health Commission, and National Medical Products Administration; participated in by: Ministry of Science and Technology, National Healthcare Security Administration, National Administration of Traditional Chinese Medicine, and Chinese Academy of Sciences)
(VII) Establishing a mixed-ownership reform fund for the development of the healthcare industry in Hainan.
Under the guidance of the National Development and Reform Commission, Hainan is supported to establish a mixed-ownership reform fund for the development of the healthcare industry featuring social capital contribution and market-oriented operation, and related industries are supported to settle and develop.
The China Securities Regulatory Commission will actively support the listing, merger and acquisition, and restructuring of strategic key enterprises supported by the mixed-ownership reform fund. (Led by: National Development and Reform Commission; participated in by: China Securities Regulatory Commission
Translated by the Foreign Affairs Office of Haikou Municipal Government
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