Hainan Free Trade Port relaxes drug market access to prescription drug online sales policy

Medical News, April 9th, April 8th, the official website of the National Development and Reform Commission issued the "Opinions on Supporting the Construction of Hainan Free Trade Port to Relax Certain Special Measures for Market Access.
"

 

Among them, several policies in the field of medicine and health are worthy of attention.

 

First, support the development of Internet prescription drug sales.

 

The "Opinions" pointed out that the Hainan Electronic Prescription Center should be established in the Lecheng Pioneer District.
For prescription drugs that are on the market in China, all prescription drugs that are sold in the country are allowed to rely on the electronic prescription center for Internet sales, except for drugs that are specifically regulated by the National Drug Administration Law.
Separate approval.

 

Hainan Electronic Prescription Center connects Internet hospitals, Hainan medical institution prescription systems, various prescription drug sales platforms, medical insurance information platforms, payment and settlement agencies, and commercial insurance agencies 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.

 

In terms of innovation access, support for drug market access will be increased.
The Hainan Provincial People’s Government optimizes the R&D, testing, production, and application environment of drugs (Chinese medicine, chemical medicine, biological products), encourages domestic high-value medical consumables, national innovative medicines 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.

 

In addition, comprehensive relaxation of contract research organization (CRO) access restrictions.
Encourage Hainan medical institutions to cooperate with contract research organizations to improve the technical capabilities and quality management of clinical trials of medical institutions.

 

Attached "Opinions" related policies in the field of Chinese medicine and health:

 

National Development and Reform Commission and Ministry of Commerce to support free trade port construction on Hainan

 

Opinions on certain special measures to relax market access

 

Development and Reform Commission (2021 ) No.
479

 

The 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, and accelerate the cultivation of international comparative advantage industries with high quality and high standards The construction of a free trade port has been approved by the Party Central Committee and the State Council.
The opinions are as follows.

 

Innovative market access methods in the medical and health field

 

　　(1) Support the development of Internet prescription drug sales.
Establish Hainan Electronic Prescription Center (providing third-party information services for prescription drug sales agencies) in the Boao Lecheng International Medical Tourism Pioneer Zone (hereinafter referred to as the "Lecheng Pioneer District").
For prescription drugs that are on the market 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 agencies, and commercial insurance agencies 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.
(Leading units: National Health Commission, National Food and Drug Administration, National Development and Reform Commission are responsible according to the division of responsibilities; Participating units: National Medical Insurance Bureau, China Banking Regulatory Commission, State Administration of Traditional Chinese Medicine)

 

　　(2) 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 large-scale medical equipment that is listed in the first (set) of major technical equipment promotion and application guidance catalogue or listed in the category A and B large-scale medical equipment configuration licensing catalogue.
Medical equipment shall be implemented in accordance with the relevant document requirements for the first (set) of domestically-made equipment.
(Leader: Ministry of Industry and Information Technology, National Health Commission, State Drug Administration; Participating Unit: National Development and Reform Commission)

 

　　(3) Increase support for drug market access.
The Hainan Provincial People’s Government optimizes the R&D, testing, production, and application environment of drugs (Chinese medicine, chemical medicine, biological products), encourages domestic high-value medical consumables, national innovative medicines 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.
(Leading units: State Food and Drug Administration, National Health Commission; Participating Units: State Administration of Traditional Chinese Medicine, General Administration of Customs)

 

　　(4) Fully relax restrictions on the entry of contract research organizations (CRO).
The People’s Government of Hainan Province has formulated policy opinions to support the establishment of contract research organizations (CRO) in Hainan’s development, 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 improve the technical capabilities of medical institutions in clinical trials.
Quality management level.
Optimize and improve the approval and filing procedures of traditional 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.
(Leader: State Drug Administration; Participants: Ministry of Science and Technology, National Health Commission, State Administration of Traditional Chinese Medicine)

 

　　(5) Support the development of Hainan's high-end medical beauty 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 in the country.
Medical equipment and cosmetics shall be registered or filed in accordance with the law, and the 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 beauty doctors to practice medicine in Hainan for a short period of time in accordance with laws and regulations, promote the development of the medical beauty tourism industry, support the introduction and organization of international and professional medical beauty industry exhibitions, summits, and forums, and standardize the approval and supervision of medical beauty institutions.
(Leading units: National Health Commission, National Food and Drug Administration; Participating Units: Ministry of Commerce, Ministry of Culture and Tourism)

 

　　(6) Optimize the access and development environment of the entire field of transplantation science.
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 research results 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 traditional 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.
(Leading units: National Health Commission, National Food and Drug Administration; Participating Units: Ministry of Science and Technology, National Medical Insurance Administration, National Administration of Traditional Chinese Medicine , Chinese Academy of Sciences)

 

　　(7) Establish a mixed reform fund for the development of the Hainan medical and health industry.
Under the guidance of the National Development and Reform Commission, support Hainan to establish a social capital contribution and market-oriented operation of the medical and health industry development mixed reform fund, 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.
(Leader: National Development and Reform Commission; Participant: China Securities Regulatory Commission)

　　Medical News, April 9th, April 8th, the official website of the National Development and Reform Commission issued the "Opinions on Supporting the Construction of Hainan Free Trade Port to Relax Certain Special Measures for Market Access.
"

 

　　Among them, several policies in the field of medicine and health are worthy of attention.

 

　　First, support the development of Internet prescription drug sales.

 

　　The "Opinions" pointed out that the Hainan Electronic Prescription Center should be established in the Lecheng Pioneer District.
For prescription drugs that are on the market in China, all prescription drugs that are sold in the country are allowed to rely on the electronic prescription center for Internet sales, except for drugs that are specifically regulated by the National Drug Administration Law.
Separate approval.

 

　　Hainan Electronic Prescription Center connects Internet hospitals, Hainan medical institution prescription systems, various prescription drug sales platforms, medical insurance information platforms, payment and settlement agencies, and commercial insurance agencies 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.

 

　　In terms of innovation access, support for drug market access will be increased.
The Hainan Provincial People’s Government optimizes the R&D, testing, production, and application environment of drugs (Chinese medicine, chemical medicine, biological products), encourages domestic high-value medical consumables, national innovative medicines 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.

 

　　In addition, comprehensive relaxation of contract research organization (CRO) access restrictions.
Encourage Hainan medical institutions to cooperate with contract research organizations to improve the technical capabilities and quality management of clinical trials of medical institutions.

 

　　Attached "Opinions" related policies in the field of Chinese medicine and health:

 

　　National Development and Reform Commission and Ministry of Commerce to support free trade port construction on Hainan

 

　　Opinions on certain special measures to relax market access

 

　　Development and Reform Commission (2021 ) No.
479

 

　　The 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, and accelerate the cultivation of international comparative advantage industries with high quality and high standards The construction of a free trade port has been approved by the Party Central Committee and the State Council.
The opinions are as follows.

 

　　Innovative market access methods in the medical and health field

 

　　(1) Support the development of Internet prescription drug sales.
Establish Hainan Electronic Prescription Center (providing third-party information services for prescription drug sales agencies) in the Boao Lecheng International Medical Tourism Pioneer Zone (hereinafter referred to as the "Lecheng Pioneer District").
For prescription drugs that are on the market 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 agencies, and commercial insurance agencies 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.
(Leading units: National Health Commission, National Food and Drug Administration, National Development and Reform Commission are responsible according to the division of responsibilities; Participating units: National Medical Insurance Bureau, China Banking Regulatory Commission, State Administration of Traditional Chinese Medicine)

 

　　(2) 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 large-scale medical equipment that is listed in the first (set) of major technical equipment promotion and application guidance catalogue or listed in the category A and B large-scale medical equipment configuration licensing catalogue.
Medical equipment shall be implemented in accordance with the relevant document requirements for the first (set) of domestically-made equipment.
(Leader: Ministry of Industry and Information Technology, National Health Commission, State Drug Administration; Participating Unit: National Development and Reform Commission)

 

　　(3) Increase support for drug market access.
The Hainan Provincial People’s Government optimizes the R&D, testing, production, and application environment of drugs (Chinese medicine, chemical medicine, biological products), encourages domestic high-value medical consumables, national innovative medicines 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.
(Leading units: State Food and Drug Administration, National Health Commission; Participating Units: State Administration of Traditional Chinese Medicine, General Administration of Customs)

 

　　(4) Fully relax restrictions on the entry of contract research organizations (CRO).
The People’s Government of Hainan Province has formulated policy opinions to support the establishment of contract research organizations (CRO) in Hainan’s development, 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 improve the technical capabilities of medical institutions in clinical trials.
Quality management level.
Optimize and improve the approval and filing procedures of traditional 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.
(Leader: State Drug Administration; Participants: Ministry of Science and Technology, National Health Commission, State Administration of Traditional Chinese Medicine)

 

　　(5) Support the development of Hainan's high-end medical beauty 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 in the country.
Medical equipment and cosmetics shall be registered or filed in accordance with the law, and the 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 beauty doctors to practice medicine in Hainan for a short period of time in accordance with laws and regulations, promote the development of the medical beauty tourism industry, support the introduction and organization of international and professional medical beauty industry exhibitions, summits, and forums, and standardize the approval and supervision of medical beauty institutions.
(Leading units: National Health Commission, National Food and Drug Administration; Participating Units: Ministry of Commerce, Ministry of Culture and Tourism)

 

　　(6) Optimize the access and development environment of the entire field of transplantation science.
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 research results 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 traditional 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.
(Leading units: National Health Commission, National Food and Drug Administration; Participating Units: Ministry of Science and Technology, National Medical Insurance Administration, National Administration of Traditional Chinese Medicine , Chinese Academy of Sciences)

 

　　(7) Establish a mixed reform fund for the development of the Hainan medical and health industry.
Under the guidance of the National Development and Reform Commission, support Hainan to establish a social capital contribution and market-oriented operation of the medical and health industry development mixed reform fund, 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.
(Leader: National Development and Reform Commission; Participant: China Securities Regulatory Commission)