China News Service, April 8th. According to the website of the National Development and Reform Commission, the National Development and Reform Commission and the Ministry of Commerce issued on the 7th the "Opinions of the National Development and Reform Commission and the Ministry of Commerce on Supporting the Construction of Hainan Free Trade Port to Relax Certain Special Measures for Market Access" opinion").
The "Opinions" mentioned that it supports the innovative development of Hainan's localized high-end medical equipment, increases support for drug market access, and supports the development of Hainan's high-end medical aesthetics industry.
Data map: In a medical beauty institution, doctors are preparing for surgery.
Photo by Hao Xuejuan
The "Opinions" mentioned that it supports the development of Internet prescription drug sales.
The Hainan Electronic Prescription Center (providing third-party information services for prescription drug sales agencies) is established in the Boao Lecheng International Medical Tourism Pioneer Zone (hereinafter referred to as "Lecheng Pioneer District"). For prescription drugs that are marketed and sold in China, except for the stipulations of the National Drug Administration Law With the exception of drugs subject to special management, Internet sales are all allowed to rely on electronic prescription centers, and no separate approval is required.
Hainan Electronic Prescription Center connects Internet hospitals, Hainan medical institution prescription systems, various prescription drug sales platforms, medical insurance information platforms, payment and settlement institutions, and commercial insurance institutions to realize unified collection of prescription-related information and prescription drug purchases, information security certification, and medical insurance settlement The Hainan Electronic Prescription Center and relevant departments of Hainan Province shall formulate detailed work plans, strengthen the management of high-risk drugs, and implement the responsibilities of relevant entities such as network security, information security, and personal privacy protection.
Utilize blockchain, quantum information and other technologies to realize online and offline linkage supervision, full traceability of drug flow, and secure data storage.
The "Opinions" clearly support the innovative development of Hainan's localized high-end medical equipment.
Encourage the first (set) of high-end medical equipment to be produced in Hainan, and for domestic large-scale ones that are listed in the first (set) of major technical equipment promotion and application guidelines or listed in the category A and B large-scale medical equipment configuration license catalog Medical equipment shall be implemented in accordance with the requirements of relevant documents for the first (set) of domestically-made equipment.
The "Opinions" require that support for drug market access be increased.
The Hainan Provincial People’s Government optimizes the R&D, testing, production, and application environment of drugs (Chinese medicine, chemical drugs, biological products), encourages domestic high-value medical consumables, national innovative drugs and Chinese medicine R&D and production enterprises to settle in Hainan, and improve Hainan’s new drug R&D financing facilities System, formulate a new drug research and development support system that matches drug marketing license holders, and encourage domestic and foreign pharmaceutical companies and drug research institutions to develop various innovative drugs and improved new drugs in Hainan.
Support the medical institutions located in Lecheng Pioneer District to carry out clinical trials in accordance with regulations.
For pharmaceutical companies registered in Hainan that have completed Phase I-III clinical trials in China and obtained marketing approval for innovative drugs, medical institutions in Hainan that have the appropriate conditions are encouraged to use them directly in accordance with the principle of “follow the approval”, and the relevant departments shall not Set additional market access requirements.
The "Opinions" mentioned that the contract research organization (CRO) access restrictions will be relaxed.
The People’s Government of Hainan Province has formulated policies and opinions to support contract research organizations (CRO) in the development of Hainan, supports the establishment of a regional ethics center for medical research international standards in Hainan, and encourages Hainan medical institutions to cooperate with contract research organizations to enhance the clinical trial technical capabilities of medical institutions and Quality management level.
Optimize and improve the approval and filing procedures of Chinese medicine preparations in medical institutions.
Develop relevant standards in accordance with the principles of safety and effectiveness, and carry out clinical trials of traditional Chinese medicines in Hainan and re-evaluation pilots after marketing.
The "Opinions" clearly support the development of Hainan's high-end medical aesthetics industry.
Encourage well-known beauty medical institutions to settle in the Lecheng Pioneer Zone. The beauty and medical institutions in Lecheng Pioneer Zone can use the medical beauty products marketed in the United States, the European Union, Japan and other countries or regions in batches, among which are drugs that need to be registered or filed within the country. Medical equipment and cosmetics should be registered or filed in accordance with the law, and Lecheng Pioneer Zone may formulate incentive measures.
The relevant departments of Hainan Province have researched and put forward the list of imported drugs, medical devices, cosmetics companies and products needed for the development of the medical beauty industry in Lecheng Pioneer District, assisted related companies in registering, and supported by the State Drug Administration.
Support foreign high-level medical aesthetic doctors to practice medicine in Hainan for a short period of time in accordance with laws and regulations, promote the development of the medical aesthetic tourism industry, support the introduction and organization of international and professional medical aesthetic industry exhibitions, summits, and forums, and standardize the approval and supervision of medical aesthetic institutions.
The "Opinions" require that the access and development environment for the entire field of transplantation science be optimized.
Gather all kinds of high-quality resources, promote the establishment of an international transplantation scientific research center, accelerate the construction of a tissue bank in accordance with international leading standards, continuously improve related systems and work systems, and promote the application and transformation of bio-renewable materials in Hainan.
Optimize the access environment for all kinds of new drugs, inspection and testing reagents, genetic technologies, and medical devices in the transplantation field, smooth market access links such as development, registration, production, and use, and support related products that meet corresponding conditions to enter priority or innovation approval procedures.
The medical institutions run by social capital and public medical institutions shall adopt consistent access standards for the approval of human organ transplant qualifications, and they shall be treated equally.
Set up an International Transplant Medical Rehabilitation Diagnosis and Treatment Center in the Lecheng Pioneer District to connect with major medical institutions to carry out transplant medical rehabilitation diagnosis and treatment.
Eligible transplant medical projects are included in the scope of medical insurance payment, facilitating the settlement of medical insurance in different places.
Encourage commercial insurance institutions to explore and research transplant diagnosis and treatment and rehabilitation-related insurance businesses.
Encourage domestic first-class Chinese medicine medical institutions to set up relevant institutions in Hainan, carry out research on integrated Chinese and Western medicine diagnosis and treatment in transplantation disciplines, and promote the integration of health and wellness.
The "Opinions" proposed the establishment of a mixed reform fund for the development of the Hainan medical and health industry.
Under the guidance of the National Development and Reform Commission, Hainan will be supported to establish a medical and health industry development mixed reform fund funded by social capital and market-oriented operation, and support the development of related industries.
The China Securities Regulatory Commission actively supports the listing, mergers and acquisitions, and restructuring of strategic key enterprises supported by the mixed reform fund.