In 2022, China's national ministries and municipalities continue to promote the development of the stem cell industry, and have introduced a number of measures to support the development of the stem cell industry. Dongfang Hospital Stem Cell Base has collected these policies and summarized them as follows for industry colleagues to learn and exchange.
National level
January 4th, 2022
The State Food and Drug Administration issued the "Drug Production Quality Control Standards - Appendix of Cell Therapy Products (Draft for comment)". The cell therapy products mentioned in the appendix refer to living cell products of human origin, including cells that have been genetically modified or not, such as autologous or allogeneic immune cells, stem cells, histiocytes or cell lines, and other products, excluding blood components for blood transfusion, hematopoietic stem cells for transplantation, reproductive related cells, and tissues and organ products composed of cells.
January 30, 2022
The Ministry of Industry and Information Technology, the National Development and Reform Commission, the Ministry of Science and Technology, the Ministry of Commerce, the National Health Commission, the Ministry of Emergency Management, the National Healthcare Security Administration, the State Drug Administration, the State Administration of Traditional Chinese Medicine and other nine departments jointly issued the "14th Five-Year Plan for the Development of the Pharmaceutical Industry". It is proposed that the development of chimeric antigen receptor T cells (CAR-T), chimeric antigen receptor NK cells (CAR-NK) and other immune cell therapy, stem cell therapy, gene therapy products and specific immunoglobulins for new targets and new indications should be emphasized. Focus on the development of ultra-large scale (≥ 10,000 liters/tank) cell culture technology, bifunctional antibodies, antibody coupled drugs, peptide coupled drugs, novel recombinant protein vaccines, nucleic acid vaccines, cell therapy and gene therapy drugs and other new biological drug industrialization preparation technology, new delivery methods and new delivery technology of biological drugs, new vaccine adjuvant.
February 8, 2022
The Ministry of Science and Technology issued a notice to seek comments on the application guidelines for five key special projects in 2022, including the national key research and development plan "Stem cell research and organ repair". The guidelines focus on five major tasks: "stem cell fate regulation and mechanism", "stem cell and organ generation and aging", "organ in-situ regeneration and mechanism", "complex organ manufacturing and functional remodeling" and "stem cell-based disease model". Hot topics include: organoids, organ-on-a-chip, external vesicle (exosome) stem cells and organ anti-aging, organ regeneration in situ, stem cells and biomaterials.
April 20, 2022
The NHC issued a notice on the issuance of the National Restricted Technology Catalog and clinical application Management standards (2022 version). The Notice of the General Office of the National Health and Family Planning Commission on the issuance of hematopoietic stem cell transplantation technology Management Specifications (2017 edition) and other 15 "restricted clinical application" medical technology management specifications and quality control indicators (National Health Office Medical hair (2017) No.7) and repealed at the same time.
April 29, 2022
The official website of the Ministry of Science and Technology issued a notice on the application guidelines for 2022 key special projects such as the national key research and development Plan "Stem cell research and organ repair". The 2022 guideline focuses on five key tasks: stem cell fate regulation and mechanism, stem cell and organ generation and aging, organ regeneration in situ and its mechanism, complex organ manufacturing and functional remodeling, and stem cell-based disease models, and intends to support 28 projects, while supporting 12 projects for young scientists.
May 10, 2022
The National Development and Reform Commission issued the "14th Five-Year Plan" for Bioeconomic Development. Planning requires the construction of quality and safety evaluation technology platforms around stem cell and cell immunotherapy products, gene therapy products, exosome therapy products, and traditional Chinese medicine. We will accelerate efforts to enhance our capacity for biotechnology innovation and carry out cutting-edge biotechnology innovation. We will develop new technologies such as gene diagnosis and treatment, stem cell therapy, and immune cell therapy, strengthen industry-university-research and application synergies, accelerate the transformation and clinical application of related technological products, and promote the formation of new therapeutic models of regenerative medicine and precision medicine. To promote policy first and first trials, make good use of the Yangtze River Delta and the Guangdong-Hong Kong-Macao Greater Bay Area sub-centers for Drug and medical device technical evaluation and inspection, and encourage pilot reforms in the areas of cell therapy, Chinese medicine and TCM medical device registration and supervision through the pilot Free Trade Zone and the Hainan Free Trade Port.
August 3, 2022
The NHC issued the 14th Five-Year Plan for the Development of Health Professionals, which clearly states that through major national projects, laboratories, and major personnel plans, we will work in cutting-edge medical fields such as omics technology, stem cell and regenerative medicine, new vaccines, biotherapy, and infectious disease prevention and control. Cultivate and discover a group of strategic scientists with profound scientific literacy, broad vision and strong forward-looking judgment.
October 25th, 2022
The State Food and Drug Administration made a response to the fifth session of the 13th National People's Congress recommendation No. 0123, "Vigorously promote the application and transformation of stem cells and vigorously develop the national stem cell industry promotion mechanism." In the next step, the State Food and Drug Administration will work with relevant state departments to establish an effective regulatory system in accordance with their respective responsibilities, continue to improve relevant management norms and technical standards, and create a good environment for the healthy development of the field of cell therapy in China.
October 31, 2022
The Verification Center of the State Food and Drug Administration officially issued the "Guidance for the Production Quality Control of Cell Therapy Products (Trial)", the full text of 13 chapters, covering the basic principles of GMP management of cell therapy products, personnel, plants, facilities and equipment, donor screening and donor materials, materials and products, production management, quality control, product traceability system and other contents. The guidelines are intended to provide guidance to manufacturers of cell therapy products, but also serve as an important reference for regulatory agencies to carry out various on-site inspections.
Local level
Beijing
January 6, 2022
The fifth session of the 15th Beijing Municipal People's Congress opened at the Beijing Convention Center. Chen Jining, Mayor of Beijing, delivered a report on the work of the municipal People's Government. The report proposes that in 2022, the construction of international science and technology innovation centers will be accelerated to build new advantages of innovation-driven development. We will accelerate the breakthrough and transformation of cutting-edge biological technologies such as new cell therapy and gene editing, and accelerate the industrialization of innovative drugs and high-end medical devices.
March 21, 2022
The official website of the Beijing Health Commission released the Notice of the Beijing Municipal Health Commission on Printing and Distributing Key Points of Beijing Health Science and Education Work in 2022. The notice proposed: do a good job in the preliminary review of stem cell and somatic cell clinical research institutions and project records, strengthen policy advisory services and pre-application counseling.
August 5th, 2022
The "Two District" Office of Beijing Municipality took the lead in formulating the "Special Plan for Improving the Freedom and Convenience of Investment in China (Beijing) Pilot Free Trade Zone" and issued it. In the plan, it is clearly proposed to explore a new model of open development and application of stem cell, gene diagnosis and treatment technology, implement major projects such as key core technology research and clinical transformation capacity improvement, and accelerate the building of world-class industrial clusters. Research and develop the relevant qualification standards of professional cell testing institutions/laboratories for quality review and inspection of stem cell preparations, support the introduction and construction of third-party drug testing institutions/laboratories with professional ability to verify cell therapy products, and the test reports issued can be used for clinical research of stem cell therapy.
Shanghai Municipality
January 26, 2022
Shanghai Pudong New Area People's Government held a policy briefing on promoting the high-quality development of the biomedical industry, officially released the "Action Plan for the High-quality Development of the biomedical Industry in Shanghai Pudong New Area (2022-2024)", and announced that under the background of accelerating the construction of the leading district in Pudong, Policies and spatial layout on supporting and accelerating the building of world-class biomedical industry clusters.
October 11, 2022
Shanghai Municipal People's Government formulated and issued the Action Plan of Shanghai to Build Future Industrial Innovation Highland and Develop and Strengthen Future Industrial Clusters. By 2035, in Pudong, Baoshan, Minhang, Jinshan, Fengxian and other regions, the carrying capacity of "Zhangjiang R & D + Made in Shanghai" will be enhanced to create future gene and cell therapy industrial clusters. Breakthroughs will be made in technologies such as accelerated carrier delivery and gene editing, and key technologies such as clinical-grade viral vectors and large-scale cell culture processes will be encouraged. Accelerate the development and transformation of cell therapy, gene therapy, oncolytic virus and other related technology products. Support R&D innovation and industrial application of key raw materials and important equipment consumables.
November 7, 2022
Shanghai Municipal Science and Technology Commission, Shanghai Municipal Economic and Information Technology Commission and Shanghai Municipal Health Commission jointly issued the "Shanghai Municipal Action Plan for Promoting Cell Therapy Technological Innovation and Industrial Development (2022-2024)". Main goals: By 2024, Shanghai cell therapy technology innovation and source capacity is significantly enhanced, clinical research and transformation application is significantly accelerated, innovative resource elements are efficiently allocated, industrial energy level is greatly improved, and the industrial scale reaches 10 billion yuan. To build a cell therapy innovation source and a new industrial plateau with prominent scientific and technological support and leading role, and deep integration of innovation chain and industrial chain.
November 15, 2022
At the main forum of "2022 Shanghai International Biomedical Industry Week - Zhangjiang Life Science International Innovation Summit", the Science and Economic Commission of Shanghai Pudong New Area issued the "Pudong New Area Cell and Gene Therapy Industry Development Action Plan (2023-2025)" and other policies, according to the "action Plan", Pudong New Area will build a landmark of the cell and gene industry on a par with the international. To provide more powerful strategic support for the construction of world-class biomedical industry cluster. By 2025, 4-5 new innovative products will be added, of which 1-2 will enter the international mainstream market; Key materials such as culture medium have been basically made domestically; A number of special scientific instruments and key equipment processes have made breakthroughs, the industrial scale has reached more than 10 billion yuan, and more than 5 new listed enterprises in the whole industrial chain have been added.
Shenzhen, Guangdong Province
January 24, 2022
The National Development and Reform Commission and the Ministry of Commerce jointly issued the Opinions on Several Special Measures to Relax Market Access in Shenzhen to Build a Pilot Demonstration Zone of Socialism with Chinese Characteristics, which includes six areas and 24 special measures to support Shenzhen's bold and bold efforts. The guideline proposes innovative market access mechanisms in the field of medicine and health. Support research and development of new medical products and technologies such as stem cell therapy, immunotherapy and gene therapy.
March 8, 2022
The Shenzhen Municipal People's Government issued the 14th Five-Year Plan for National Economic and Social Development of Dapeng New Area of Shenzhen and the Outline of Long-term Goals for 2035. Focusing on cutting-edge medical technology research such as gene sequencing and stem cell clinical research, we will attract high-quality precision medical projects around the world to be implemented and transformed, accelerate the construction of international life science and technology centers, biological homes and other projects, introduce international research teams, innovation platforms and other cooperation projects, and introduce a number of high-end industrial carriers with distinctive characteristics, clear positioning, complete supporting facilities, and green ecology. Relying on the China-Israel science and technology industry Innovation Cooperation Demonstration Zone, we will carry out precision medicine innovation cooperation. We will strive to carry out pilot services of licensed medical treatment (stem cell therapy, biological products therapy, etc.), carry out early clinical research on stem cells and biological products in the new district, and explore the path of transforming research results into treatment services.
June 6, 2022
Shenzhen issued an important policy document on the Development and Growth of Strategic Emerging Industrial Clusters and the Cultivation and Development of Future Industries, cultivating and growing the "20+8" industrial clusters, focusing on the cultivation and development of eight major future industries, cultivating new momentum and enhancing new potential energy. Including synthetic biology, blockchain, cells and genes, space technology, brain science and brain-like intelligence, deep earth and deep sea, visible light communication and light computing, quantum information. We will focus on the development of cell technology, gene technology, cell and gene therapy technology, biological breeding technology and other fields, improve the approval mechanism, supervision system, clinical trial incentive mechanism, application and promotion mechanism of cell and gene drugs, and accelerate the construction of leading areas of cell and gene industry.
June 30, 2022
Shenzhen Dapeng New Area Management Committee officially issued the "Dapeng New Area Strategic Emerging Industry Development" 14th Five-Year Plan ". It is clearly proposed that: focusing on the precision medicine pioneer area in the Guangdong-Hong Kong-Macao Greater Bay Area, cultivating multi-gradient innovation subjects, accurately positioning investment directions, increasing the introduction of leading enterprises, establishing a potential enterprise cultivation database, promoting the development of the cell therapy industry in terms of promoting the scale of enterprises, improving clinical medical services, accelerating the research and development and industrialization of gene therapy drugs, and exploring the development of precision medical tourism.
July 26, 2022
Shenzhen Municipal Development and Reform Commission has repeatedly issued three files: "Several measures to promote the high-quality development of biomedical industrial clusters in Shenzhen", "Several measures to promote the high-quality development of high-end medical device industrial clusters in Shenzhen" and "Several measures to promote the high-quality development of large health industrial clusters in Shenzhen". Among them, the "Several Measures to promote the high-quality development of large health industry Clusters in Shenzhen" proposed to create new heights in the gene and immune cell therapy industry, cultivate and develop new formats such as stem cells, and support the construction of cell and gene biosafety testing platforms.
Hunan Province
April 28, 2022
Hunan Provincial Drug Supervision Bureau held the Provincial People's Congress CPPCC proposal communication meeting and stem cell clinical research management symposium to carry out in-depth discussions on the proposals of "on supporting the development of stem cell industry" and "on supporting the development of stem cell and regenerative medicine industry cluster in Hunan Province". At the symposium, the representatives suggested that Hunan, with reference to the practice of coastal areas, attract the national stem cell technology and filing enterprises to gather in the park, forming a siphon effect, accelerating the landing, transformation, incubation and industrialization of scientific research projects, and promoting the development of Hunan stem cell and regenerative medicine industry clusters; Support stem cell companies to quickly declare stem cell drugs and fill the gap of first-class biological innovative drugs in Hunan Province and even in China.
June 10, 2022
A reply letter from Hunan Drug Administration on the proposal No. 0490 of the Fifth Session of the 12th CPPCC Provincial Committee "Seize important development opportunities to Strengthen the construction of biological drug industry chain in our province", proposed that the Provincial Health Commission and the Provincial drug Administration actively support stem cell research and application, and actively build a stem cell research innovation platform. To recommend a number of stem cell basic research and applied basic research projects to the provincial Science and Technology Department. At the basic research and development level, optimization and integration are promoted, and the National Engineering Research Center of Human stem Cells has incorporated new sequence management, and more than 200 innovation platforms at the national and provincial levels have been laid out, such as the national and local joint engineering research center for infectious diseases and tumor gene diagnosis technology.
July 15, 2022
The Drug Administration of Hunan Province, the Health Commission of Hunan Province and the Science and Technology Department of Hunan Province issued the Notice on Strengthening the Clinical Research Management of Cell Therapy Products (Hunan Drug Administration (2022) No. 19). It is clearly proposed to strengthen the clinical research management of cell products, strengthen the quality control of cell products, standardize the release and management of cell product information, and severely crack down on violations related to cell products.
Yunnan Province
March 4, 2022
The Yunnan delegation, which attended the fifth session of the 13th National People's Congress, submitted six proposals and 19 suggestions to the congress in the name of the whole delegation. These include the Bill on the formulation and improvement of laws in the field of cells. As early as June 2020, the General Office of the Yunnan Provincial People's Government issued a Notice on Establishing a Joint Conference System for Promoting Cell Industry Development in Yunnan Province, proposing to coordinate and promote the development of the province's cell industry; Strengthen the guidance for the development of the cell industry in the province, and study and formulate policies and measures to promote the development of the cell industry.
August 16, 2022
The official website of Kunming Municipal People's Government officially released the "Kunming Cell Industry Development Plan (2021-2035)". The plan proposes that the city will strive to build a stem cell and regenerative medicine cluster, making it a landmark highlight of Kunming's health industry. Explore and standardize cell therapy technical standards, preparation standards and clinical applications, and promote