Summary . . New policies on stem cells issued by national and local governments

Science magazine has ranked stem cell research as one of the world's top ten scientific achievements.
2020, stem cells will achieve good results in the global clinical exploration of the fight against neo-crown pneumonia, and will also contribute to the faster development of the stem cell industry.
since January 2020, national and local governments have issued documents to support stem cell transformation and industrialization.
this paper summarizes the new policies issued so far this year to help you understand the development trend of the stem cell industry at the policy level.
On September 1st, the Regulations on the Free Trade Pilot Zone of the Former Haihekou of the Shenzhen Special Economic Zone, the first free trade zone legislation of the country, the Regulations on the Free Trade Pilot Zone of the former Haihekou of the Shenzhen Special Economic Zone (hereinafter referred to as the "Regulations on the Free Trade Zone") and the revised Regulations on the Former Haishekou Modern Service Cooperation Zone of the Shenzhen Special Economic Zone (hereinafter referred to as the "Regulations on the Cooperation Zone"), will come into effect on October 1st.
Article 51 of the FTZ Regulations clearly states that medical institutions and scientific research institutions in the FTZ may, in accordance with their own technical capabilities, carry out research and transformation applications on new technologies such as stem cells, immune cells, gene therapy and monoanti-drug and tissue engineering in accordance with the relevant provisions.
August, "Nanjing City to build a new pharmaceutical and life and health industry landmark action plan" August 12, the Nanjing Municipal People's Government Office issued "Nanjing City to build a new pharmaceutical and life and health industry landmark action plan." The general idea of
is to coordinate and promote the joint development of medicine (biomedicine), medical (medical service), medical engineering (medical equipment), medical letter (medical information), medical care (rehabilitation and old-age care), medical system (sports health), further improve the industrial map, clarify the direction and focus of development, and accelerate the construction of a relatively perfect and unique competitive industrial chain.
put forward the development of cell and gene industry, focusing on the development of cell storage, cell technology research and development, immunocellular therapy, stem cell therapy, gene sequencing, gene editing, genetic engineering drugs, gene therapy, gene chip, gene big data and so on.
to accelerate the construction of the entire industrial chain from cell storage, core reagents and cell culture base product development, clinical research to practical application.
open up the upstream and downstream industrial chain of cell therapy, form an industrial closure, realize the two-way cooperation between enterprises and enterprises, enterprises and hospitals, enterprises and scientific research institutions, and promote the rapid industrialization of cell therapy.
Technical Guidelines for Clinical Trials of Human Stem Cells and Their Derivative Cell Therapy Products (Draft for Comments) August 4, the Drug Review Center of the State Drug Administration has drafted the Technical Guidelines for Clinical Trials of Human Stem Cells and Their Derivative Cell Therapy Products (Draft for Comments) with a view to providing more targeted advice and guidance to registered applicants for drug research and development and researchers conducting drug clinical trials.
These Guidelines are applicable to stem cell-related products that are developed and registered in accordance with the Drug Administration Law, the Drug Registration Management Measures, etc., and are designed to provide the necessary technical guidance for the overall planning, design, implementation and analysis of clinical trials of such products, to standardize the evaluation methods of drug clinical trial candidates (hereinafter referred to as bidders) and clinical trial researchers on the safety and effectiveness of stem cell-related products, and to maximize the protection of the safety and interests of subjects participating in clinical trials.
July 2020, the Drug Review Center of the State Drug Administration issued the Technical Guidelines for Clinical Trials of Immunocell Therapeutic Products (Draft for Comments) to provide more targeted advice and guidance to registered applicants for drug research and development and researchers conducting drug clinical trials.
The content of these Guidelines applies to the development and registration of declared cell immunotherapy products in accordance with relevant regulations on drug management, and is intended to provide the necessary technical guidance for the overall planning, design, implementation and analysis of clinical trials for such products in order to reduce the risk of subjects participating in clinical trials and to standardize the evaluation of the safety and effectiveity of cell immunotherapy products.
June, the Guangdong Provincial Market Supervision Authority issued a Letter on the Reply to the Proposal of the Representative No. 1037 of the Third Session of the 13th National People's Congress of Guangdong Province.
For the representative's proposal to speed up the establishment of a "stem cell and regenerative medicine mass production and listing policy" to enable Guangdong, Hong Kong and Macao Bay Area to win in the industrial starting line, the Comprehensive Provincial Development and Reform Commission, the provincial health and health committee' views, the answer is as follows.
letter clearly put forward the next step of work ideas: (1) the provincial Development and Reform Commission will actively study in accordance with their duties to promote the healthy development of stem cells and regenerative medicine policy measures, in cooperation with the relevant functional departments to promote stem cells and regenerative medicine-related technologies in Guangdong, Hong Kong, Macao and the Bay Area first test.
(2) The Provincial Health and Health Commission will give full play to the role of the provincial stem cell clinical research expert committee and the provincial medical ethics expert committee, strengthen the training of stem cell clinical research management, and do a good job of review and guidance.
in accordance with the requirements of the state combined with the actual situation in our province, support Guangdong, Hong Kong, Macao and the Gulf region related institutions to declare stem cell clinical research institutions and projects for the record, and actively explore stem cell clinical research collaborative innovation mechanism.
)The Provincial Drug Administration will implement the Provisions of the Measures for the Administration of Drug Registration, the Regulations on the Administration of Drug Clinical Trial Institutions, the Code of Quality Management of Drug Clinical Trials and the special requirements for stem cell supervision, strengthen day-to-day supervision, optimize service processes, strengthen policy communication and technical guidance, and cooperate with the State Drug Administration. Do a good job in accordance with the drug research and development and registration of human sources of live cell products cell therapy products registration related to on-site inspection, post-market changes in the record, reporting matters management and other work, with the provincial Health and Health Commission to continue to do a good job in stem cell clinical research institutions and project filing work, accelerate the healthy development of stem cell and regenerative medicine industry in our province.
On June 17th, the official website of the Hainan Provincial People's Government issued the Regulations on the International Medical Tourism Advance Zone of Boao Lecheng, Hainan Free Trade Port.
regulations, it is clearly stated that medical institutions in the advance area may carry out research and conversion applications on new technologies such as stem cells, immunocellular therapy, monoantigene, gene therapy and tissue engineering in the advance area.
The Regulations on the International Medical Tourism Advance Zone of Boao Lecheng, Hainan Free Trade Port, were adopted by the Standing Committee of the Sixth People's Congress of Hainan Province on June 16, 2020 and are he heeded and shall come into effect as of the date of publication.
notice on the establishment of a joint conference system for promoting the development of the cell industry in Yunnan Province, in order to further strengthen inter-departmental coordination and coordination, form a joint effort to accelerate the development of the province's cell industry, the provincial people's government decided to establish a joint meeting system for the promotion of the development of the cell industry in Yunnan Province.
Under the leadership of the provincial people's government, coordinate and promote the development of the province's cell industry, strengthen guidance on the development of the province's cell industry, study and formulate policies and measures to promote the development of the cell industry, coordinate and solve major problems encountered in the promotion of the work, urge relevant departments and units to promote the implementation of the work, and complete other matters as associed by the provincial people's government.
, the Dalian Municipal Government issued the Opinions on Speeding Up the Innovation and Development of the Life Safety Industry.
actively cultivate and introduce advanced technology and enterprises at home and abroad to build a whole industry chain of cell therapy, including storage, research and development, production, transportation, treatment, equipment, etc.
supports research on key technologies such as stem cell and regenerative medicine and immunocellular therapy, focusing on product development and clinical transformation of cell therapy in the fields of antiviral, anti-inflammatory, tissue regeneration, anti-aging, etc.
actively support enterprises to carry out epidemiological, cancer treatment, immunomodulation, organ degenerative injury repair and other medical problems, focusing on osteoarthritis, stroke, childhood cerebral palsy, heart disease, diabetes, spinal injury and autoimmune diseases and other fields.
high-quality clinical resources to advance stem cell therapy products and services for clinical trials.
promote the development of medical, pharmaceutical and health care industries.
Encourage our city's medical institutions joint enterprises, related departments, etc. to form a chain of application innovation, jointly establish the innovation and development system of production, learning, research, medicine, CPPCC, and promote the deep integration of innovation chain, industrial chain, service chain.
strengthen the construction of preclinical research support service system, improve the service capacity of new drug screening, new drug safety evaluation, experimental animals and other preclinical public platforms.
actively concerned about the national drug, medical device procurement policy changes, to support our city's innovative products in the local clinical application.
Integrate the city's high-quality medical resources, create innovative drugs, high-end medical devices, stem cell therapy and other new technologies, new products clinical application pilot base, form a "demonstration application - clinical evaluation - technological innovation - radiation promotion" virtuous circle, and actively apply for new technologies, new products clinical transformation, promotion and application of the pilot national qualifications.
"Several Opinions on Promoting the High-Quality Development of the Pharmaceutical Industry in Zhejiang Province" A number of opinions on promoting the high-quality development of the pharmaceutical industry in Zhejiang Province were jointly issued by the Zhejiang Economic and Information Bureau, the Provincial Development and Reform Commission, the Provincial Science and Technology Department, the Provincial Finance Department, the Provincial Health and Health Commission, the Provincial Health Insurance Bureau and the Provincial Drug Administration.
clearly supports technological innovation and industrial development in emerging fields such as immunotherapy, gene therapy, stem cell therapy, and focuses on promoting antibody-based biotherapy drugs, recombinant protein drugs in urgent clinical need, vaccines against major diseases, nucleic acid drugs, gene therapy drugs and cell therapy drugs, and other product development and industrialization.
to promote core technology and new drug creation.
support enterprises to focus on clinical needs, accelerate the creation and industrialization of new drugs, in the gene industry, cell industry, innovative vaccines, high-performance imaging equipment, precision rapid diagnosis reagents and other key areas to achieve technological breakthroughs and application promotion.
"On the 2020 "Binhai New Area Cell Industry Technology Innovation Action Plan" work points notice" Tianjin Binhai New Area Science and Technology Bureau issued "on 2020 "Binhai New Area Cell Industry Technology Innovation Action Plan" work points notice.
: strive for stem cells, immunocellular therapy and other advanced biological treatment technology clinical application pilot.
Binhai New Area actively strive for the support of the Municipal Health And Wellness Commission, the Municipal Science and Technology Bureau, the Municipal Market Bureau and other departments to jointly study and formulate relevant preferential policies to support the development of the biopharmaceutical industry.
In April, nine departments of Guangdong Province jointly issued "Several Policy Measures on Promoting the Innovation and Development of Biopharmaceuticals" on April 8, Guangdong Provincial Science and Technology Department, Guangdong Provincial Development and Reform Commission, Guangdong Provincial Industry and Information Technology Department, Guangdong Provincial Finance Department, Guangdong Provincial Health and Health Commission, Guangdong Provincial Medical Security Bureau, Guangdong Provincial Local Finance The Supervisory Authority, the Guangdong Provincial Administration of Traditional Chinese Medicine, the Guangdong Provincial Drug Administration and other departments jointly issued "Several Policy Measures on Promoting the Innovation and Development of Biopharmaceuticals" (hereinafter referred to as "Measures"), which are aimed at enhancing the original innovation capability and international competitiveness of biopharmaceuticals, promoting the development of high-quality biopharmaceutical technology and industries, and enhancing biosecurity governance capabilities.
measures clearly put forward: to support Shenzhen to do deep high-performance medical devices, gene sequencing and bio-information analysis, cell therapy and other industries, cultivate the world's benchmark biopharmaceutical enterprises and research institutions, to create a global source of biomedical innovation and development.
organizations to implement precision medicine and stem cells, new drug creation, chinese medicine key technical equipment, high-end medical devices and other provincial key special projects.
on March 31st, the Ministry of Science and Technology issued the Notice of the Ministry of Science and Technology on the Release of the 2020 Project Declaration Guidelines for Key Special Projects such as "Stem Cell and Conversion Research" of the National Key Research and Development Program (No. 83 of 2020).
Stem cell and transformation research pilot project is based on the "National Medium- and Long-Term Science and Technology Development Plan Outline (2006-2020)" deployment and "the State Council on deepening the central financial science and technology plan (special, fund, etc.) management reform program" arrangements to take the lead in the establishment of the national key research and development plan special, according to the innovation chain deployed eight aspects of the task.
2020, it is proposed to prioritize support for nine research directions.
In the same direction, only 1 item is supported in principle, only if the results of the project review are similar and the technical route is significantly different, 2 items can be supported at the same time, and a dynamic adjustment mechanism can be established, based on the results of the mid-term assessment, and then continue to support on the basis of merit.
240 million yuan (of which 6 are to be supported by young scientists, and the total amount allocated by the State is not more than 36 million yuan).
In February, Jiangxi Province opened the emergency audit channel for clinical research on stem cell therapy for new coronary pneumonia Jiangxi Provincial Drug Administration opened the emergency audit channel for stem cell clinical research, and the Joint Provincial Health and Health Commission completed the safety and safety of the new coronavirus (2019-nCoV) pneumonia-caused acute respiratory distress syndrome caused by human umbilical cord-filled stem cells at nanchang University's First Affiliated Hospital for the first time. The initial examination of the two stem cell clinical research projects, "Clinical research on the treatment of severe acute respiratory distress syndrome caused by neo-coronavirus pneumonia" and "Clinical study of human natural killer cells" and the second affiliated hospital of Nanchang University, organized the provincial stem cell clinical research expert committee and the medical ethics expert committee to review the declared project and report it to the National Health Commission and the National Drug Administration for examination and filing.
of this clinical research will open up new avenues for the treatment of severe and critically ill patients caused by the new coronavirus.
January, Kunming Great Health Industry Development Plan (2019-2030) Kunming City's official website issued the Kunming Great Health Industry Development Plan (2019-2030), clearly focusing on 7 key areas 27 directions and 7 characteristic clusters, the implementation of 8 major projects, the large health industry will be cultivated into Kunming's banner industry, some industries become technology-leading, distinctive features, demonstration-led national benchmark, to help China's health city and world-class healthy living destination construction.
industry mainly covers medical services, health products, health management, health care, fitness and leisure, health tourism, wisdom and health 7 key areas.
clear: set the city's efforts to build stem cells and regenerative medicine cluster, Kunming's large health industry has become an iconic bright spot and brand.
policy requirements for cutting-edge life science trials such as stem cell and regenerative medicine products and technologies