Source: Stem cell base

In 2023, various ministries and commissions of the state and provinces and cities 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

March 23, 2023

The General offices of the Communist Party of China Central Committee and The State Council issued a guideline on Further improving the medical and health service system. It is proposed in the "Opinions" that we should strengthen the research and development system and capacity building of clinical medicine, public health and medical devices, and develop cutting-edge medical technologies such as omics technology, stem cell and regenerative medicine, new vaccines, biotherapy, and precision medicine.

April 25th, 2023

The Center for Drug Evaluation (CDE) of the State Drug Administration issued the "Technical Guidelines for Pharmaceutical Research and Evaluation of human Stem Cell Products (Trial)". These guidelines provide advice on the technical aspects of pharmaceutical research on stem cell products developed under pharmaceutical products.

May 9, 2023

The Science and Education Department of the National Health Commission issued the Guidelines for Somatic Cell Clinical Research (Draft for Public Comment). The guidelines are a major step forward in addressing the policy and regulatory gaps surrounding investigator-initiated clinical studies (Iits).

May 26, 2023

The Ministry of Science and Technology issued the Implementation Rules of the Regulations on the Management of Human Genetic Resources. These Rules deepen the reform of "release and management service" and optimize the requirements and processes for administrative licensing and filing of human genetic resources activities.

June 21, 2023

CDE published the Technical Guidelines for Clinical Trials of Human Derived Stem Cells and their Derived cell Therapeutic Products (Trial). The publication of the guidelines provides technical guidance and recommendations for conducting clinical trials of human derived stem cells and their derived cell therapeutic products.

June 26, 2023

CDE publicly solicited Questions and Answers on Pharmaceutical Changes in Autologous CAR-T cell Therapy Products (Draft for Comment), which helps to further standardize and guide the change research and declaration of CAR-T products.

July 25th, 2023

The CDE published the Guidelines for Clinical Communication of Cell and gene Therapy Products (Draft for comment). The purpose of these guidelines is to provide suggestions for the preparation of communication materials and the consideration of clinical research and development factors during the clinical research and development of cell and gene therapy products, so as to improve the efficiency of communication and facilitate the smooth progress of clinical research and development of cell and gene therapy products.

August 13, 2023

The State Council issued the Opinions on Further Optimizing the Environment for Foreign Investment and Increasing Efforts to Attract Foreign Investment, calling for a better overall balance between domestic and international situations, creating a market-oriented, law-based and internationalized first-class business environment, giving full play to the advantages of China's ultra-large market, and making greater efforts and more effective in attracting and utilizing foreign investment. It will contribute to promoting high-level opening up and comprehensively building a modern socialist country.

August 29, 2023

The State Council issued the "Hetao Shenzhen-Hong Kong Science and Technology Innovation Cooperation Zone Shenzhen Park Development Plan". The plan proposes to explore and establish a new management model suitable for the research and development of new biological drug devices such as cell therapy and gene therapy in the customs supervision area of Shenzhen Park in accordance with laws and regulations, and to relax the access restrictions for foreign biomedical enterprises on a pilot basis.

September 13, 2023

The CDE has released the Technical Guidelines for Clinical Trials of Mesenchymal Stem Cells for Prevention and Treatment of graft-versus-host disease (Draft for comment). These guidelines apply to mesenchymal stem cell products derived from various tissues such as bone marrow, umbilical cord, cord blood, or fat, as well as mesenchymal cell products derived from embryonic stem cells or induced pluripotent stem cells.

October 8, 2023

Ten departments, including the Ministry of Science and Technology, the Ministry of Education, the Ministry of Industry and Information Technology, and the National Health Commission, jointly issued the Measures for Ethical Review of Science and Technology (Trial Implementation). This method is a concrete measure to implement the "Opinions on Strengthening the Ethical Governance of Science and Technology", and realize the whole process of ethical supervision of scientific research and technology development activities, which is of great significance to improve the level of ethical governance of science and technology in China.

October 31, 2023

The plan focuses on the strategic positioning and development goals of the Xinjiang Pilot Free Trade Zone, puts forward 25 specific measures from eight aspects, including accelerating the transformation of government functions, deepening the reform of investment fields, and creating an open industrial system with characteristics, and proposes to explore and carry out research on cutting-edge clinical diagnosis and treatment technologies such as stem cells, immune cells, and gene therapy.

November 23, 2023

The State Council issued the Work Plan to Support Beijing in Deepening the construction of a Comprehensive Demonstration Zone for the wider opening of the National Service Industry. The plan proposes to support qualified foreign and Hong Kong, Macao and Taiwan doctors to set up clinics in Beijing; Explore equity incentive methods for foreign and Hong Kong, Macao and Taiwan employees of pharmaceutical R&D enterprises in the field of stem cells and genes; Support qualified medical institutions to carry out stem cell and other clinical trials; Support international cooperation in stem cell and gene research and development. To facilitate human genetic resources management services for enterprises in Beijing, Hong Kong and Macao.

Local level

◆Shenzhen, Guangdong Province◆

January 9, 2023

The Standing Committee of the Shenzhen Municipal People's Congress issued the Regulations on the Promotion of Cell and Gene Industry in the Shenzhen Special Economic Zone. The regulation is the country's first special legislation on the cell and gene industry, with 72 chapters in nine chapters, including general provisions, cell collection and storage, cell and gene product research and development, drug expansion clinical trials, gene technology application, marketing authorization and product production, safeguard measures, legal liability, and supplementary provisions.

August 30, 2023

Shenzhen Municipal Bureau of Finance issued the Announcement on the Public selection of Shenzhen Cell and Gene Industry Fund Management institutions. The announcement proposed that with the approval of the municipal government, under the guidance of the Municipal Finance Bureau and the Municipal Science and Technology Innovation Commission, Shenzhen Guiding Fund took the lead in initiating the establishment of Shenzhen Cell and gene Industry Fund, and publicly selected fund management institutions.

◆Shandong Province◆

January 19, 2023

The People's Government of Shandong Province issued the Plan for Deepening Reform and Innovation in the China (Shandong) Pilot Free Trade Zone. The plan proposes to support the implementation of multi-center clinical trials for biomedical products such as gene therapy and cell therapy and the mutual recognition of ethical review results. We will explore and formulate relevant standard systems to carry out pilot clinical transformation applications such as stem cell therapy and bioartificial liver under controllable risk conditions.

◆Zhejiang Province◆

February 20, 2023

Zhejiang Provincial People's Government General Office "Zhejiang Provincial People's Government General Office issued guidance on Cultivating and developing Future industries". The guidelines focus on the development of advanced diagnosis and treatment technologies such as cell and gene therapy, stem cells, nuclear medicine, imaging diagnosis, multi-omics data analysis, and medical artificial intelligence, as well as medical devices and equipment such as artificial tissues and organs and digital drugs.

◆Beijing◆

February 20, 2023

Beijing Economic and Technological Development Area issued the "Beijing Economic and Technological Development Area on Several measures to Promote the high-quality development of Cell and gene therapy Industry". The measures propose to give full play to the advantages of original innovation and clinical resources in the field of cell and gene therapy in Beijing, closely combine the existing industrial foundation of the development zone, focus on varieties development, market application, platform construction, talent gathering and other aspects, and strive to build the economic development zone into a cell and gene therapy industry gathering area, and accelerate the construction of the global "new drug intelligent manufacturing" industrial highland.

September 25th, 2023

Beijing Municipal Bureau of Economy and Information Technology, Beijing Municipal Commission of Science and Technology, Zhongguancun Science and Technology Park Management Committee, Beijing Municipal Health Commission, Beijing Municipal Market Supervision Administration, Beijing Intellectual Property Office, Beijing Drug Administration, Beijing Bureau of Human Resources Work, Beijing Customs and other nine departments issued the "Several Measures to support the high-quality development of Beauty and health Industry". Measures will be taken to strengthen the protection of innovative intellectual property rights, support the construction of adverse reaction monitoring system for cosmetics and promote the concentration of high-level enterprises. In particular, it is mentioned that it supports innovative research and development and application of new raw materials for cosmetics. Construction of cosmetics new raw materials innovation highland. We will encourage research on underlying technologies such as gene editing and new cell culture.

◆Hebei Province◆

April 7, 2023

The General Office of Hebei Provincial People's Government issued the "Hebei Province Strategic Emerging Industry Integration Cluster Development Action Plan (2023-2027)" action plan: To support and guide Shijiazhuang, Qinhuangdao, Baoding, Langfang and Xiongan New Area, focusing on new genomics technologies, gene editing, cell and gene therapy and other key areas, to carry out key technological research such as high-throughput target screening, in vitro gene modification systems, novel carrier delivery, high-quality source cell preparation, and cell product traceability. Accelerate the development and commercialization process of cell and gene therapy drugs, and form industrial agglomeration and collaboration in key processes, upstream and downstream core materials, and product development. And from the strengthening of overall coordination, strengthening factor guarantee, precise investment, enhance innovation ability, strengthen coordination and integration, cultivate market players to provide safeguard measures.

◆Tianjin◆

July 27, 2023

The fourth meeting of the Standing Committee of the 18th Tianjin Municipal People's Congress deliberated and passed the "Tianjin Gene and Cell Industry Promotion Regulations". The formulation of the regulations is of great significance for leading and promoting the high-quality development of Tianjin's gene and cell industry, seizing new opportunities for the development of the biomedical industry, and better meeting the needs of the people for health.

◆Shandong Province◆

August 28, 2023

The "Several Measures to Promote the Innovation and Development of Cell therapy Industry in Jinan Area of China (Shandong) Pilot Free Trade Zone" issued by the Shandong Provincial government formulated 14 innovation policies from four aspects to promote the high-quality development of Jinan cell therapy industry.

October 23, 2023

The People's Government of Shandong Province issued Several Measures for Further Optimizing the Environment for Foreign Investment and Making Greater Efforts to Attract and Utilize Foreign Investment in Shandong Province. The document includes 23 specific measures in six aspects, referring to encouraging foreign-invested enterprises to carry out clinical trials of overseas listed cell and gene therapy drugs in Shandong in accordance with the law, and optimizing the review and approval process for the listing registration application of drugs produced overseas that have been transferred to Shandong.

◆Shanghai◆

September 18, 2023

Shanghai Municipal Science and Technology Commission, Municipal Economic Informatization Commission and Municipal Health Commission jointly issued the Action Plan for Promoting Gene Therapy Technological Innovation and Industrial Development in Shanghai (2023-2025). The program contains 12 major tasks and 8 safeguard measures in 4 aspects, aiming to enhance the innovation source and clinical research transformation capacity in the field of gene therapy, and improve the accessibility of gene therapy products and the level of industrial development.

◆Jilin Province◆

December 5th, 2023

The General Office of the People's Government of Jilin Province issued the Implementation Plan for Building a New track for the biomedical and High-end Medical device Industry in Jilin Province. The plan proposes that in the field of cell therapy, focus on the development of cell preparations, cell preparation technology research, and promote the filing of cell research projects.