Cells and genes are one of the most promising areas in the biomedical industry, and an important direction for the development of the life and health industry in the future.
With the rapid development of biological cell technology and industry around the world, "cell ** and clinical transformation" has become a major topic in the development of health security in China during the 14th Five-Year Plan. China has given strong support to the health industry, especially the clinical research of cell technology and products, and the national authorities and local governments have successively promulgated a number of favorable policies.
Today, let's take a look at what incentive policies have been introduced in the field of cell industry in the past year!
At the national level
March 23, 2023
The General Office of the Communist Party of China and the General Office of the Communist Party of China issued the "Opinions on Further Improving the Medical and Health Service System".
Opinions: strengthen the research and development system and capacity building of clinical medicine, public health and medical devices, and develop omics technologyStem Cells and Regenerative Medicine, new vaccines, biological, precision medicine and other cutting-edge medical technologies.
April 25, 2023
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) issued the Technical Guidelines for Pharmaceutical Research and Evaluation of Human Stem Cell Products (Trial).
It is developed in accordance with the drugTechnical issues in the pharmaceutical research of stem cell productsProvide advice.
May 9, 2023
The Department of Science and Education of the National Health Commission issued the Guidelines for Somatic Cell Clinical Research (Draft for Public Comment).
A major step has been taken to fill the gaps in policies and regulations related to investigator-initiated clinical studies (IIT).
May 26, 2023
The Ministry of Science and Technology issued the "Detailed Rules for the Implementation of the Regulations on the Management of Human Genetic Resources".
These Implementation Rules deepen the reform of "delegating power, delegating power, delegating power, and improving services", optimizing the requirements and processes for administrative licensing and filing of human genetic resources activities.
June 21, 2023
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) issued the Technical Guidelines for Clinical Trials of Human Stem Cells and Their Derived Cells
The release of the guidelines provides technical guidance and recommendations for conducting clinical trials of human-derived stem cells and their derived cell** products.
June 26, 2023
Center for Drug Evaluation (CDE) of the National Medical Products Administration, "Research Questions and Answers on Pharmaceutical Changes of Autologous CAR-T Cell ** Products (Draft for Comments)".
It will help to further standardize and guide the change research and declaration of CAR-T products.
July 25, 2023
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) issued the Technical Guidelines for Clinically Related Communication of Cell and Gene ** Products (Draft for Comments).
The purpose of this study is to provide suggestions on the preparation of communication materials and the consideration of clinical development elements in the clinical development of cell and gene products, so as to improve the efficiency of communication and help the clinical research and development of cell and gene products to be carried out smoothly.
August 13, 2023
The "Opinions on Further Optimizing the Environment for Foreign Investment and Increasing the Efforts to Attract Foreign Investment" was issued
It is required to better coordinate the overall domestic and international situations, create a market-oriented, law-based, and international first-class business environment, give full play to the advantages of China's super-large-scale market, attract and utilize foreign investment more vigorously and effectively, and contribute to promoting high-level opening up and building a modern socialist country in an all-round way.
August 29, 023
The Development Plan for the Shenzhen Park of the Shenzhen-Hong Kong Science and Technology Innovation Co-operation Zone in the Loop was issued
The plan proposes to explore the establishment of a new management model suitable for the research and development of new biological drugs and devices such as cells and genes in the customs supervision area of Shenzhen Park in accordance with laws and regulations, and to relax the access restrictions of foreign-funded biomedical enterprises on a pilot basis.
September 13, 2023
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) issued the Technical Guidelines for Clinical Trials of Mesenchymal Stem Cells for the Prevention and Treatment of Graft-versus-Host Disease (Draft for Comments).
These guidelines apply to mesenchymal stem cell products from a variety of tissues such as bone marrow, umbilical cord, umbilical 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 the Review of Science and Technology Ethics (for Trial Implementation).
This method is a specific measure to implement the "Opinions on Strengthening the Ethical Governance of Science and Technology", and realizes the ethical supervision of the whole process of scientific research and technological development activities, which is of great significance for improving the level of ethical governance of science and technology in China.
October 31, 2023
The "Overall Plan for China (Xinjiang) Free ** Pilot Zone" was publicly released
The plan focuses on the strategic positioning and development goals of the Xinjiang Pilot Free Trade Zone, and proposes 25 specific measures from 8 aspects, including accelerating the transformation of first-class functions, deepening the reform of the investment field, and building an open characteristic industrial systemExplore and carry out research on cutting-edge clinical diagnosis and treatment technologies such as stem cells, immune cells, and genes.
November 23, 2023
The "Work Plan for Supporting Beijing to Deepen the Construction of a Comprehensive Demonstration Zone for the Expansion and Opening-up of the National Service Industry" was issued
The plan proposes to support qualified foreign and Hong Kong, Macao and Taiwan doctors to open clinics in BeijingExplore equity incentives 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 clinical trials such as stem cells;Support international cooperation in stem cell and gene research and development. Promote the facilitation of human genetic resources management services for enterprises in Beijing, Hong Kong and Macao.
Local level
Shenzhen, Guangdong Province
January 9, 2023
Issued by the Standing Committee of the Shenzhen Municipal People's CongressRegulations on the Promotion of Cell and Gene Industry in the Shenzhen Special Economic Zone
The regulations are the first special legislation for the cell and gene industry in China, with a total of nine chapters and 72 articles, 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 liabilities, and supplementary provisions.
August 30, 2023
The Shenzhen Municipal Bureau of Finance issued the "Announcement on the Public Selection of the Cell and Gene Industry Management Institutions in Shenzhen".
The announcement proposes that with the approval of the city, under the guidance of the Municipal Finance Bureau and the Municipal Science and Technology Innovation Commission, Shenzhen will take the lead in initiating the establishment of the Shenzhen Cell and Gene Industry, and openly select the first management institution.
Shandong Province
January 19, 2023
The people of Shandong Province issued the "China (Shandong) Free Pilot Zone Deepening Reform and Innovation Plan".
The plan proposes to support multi-center clinical trials of biomedical products such as genes and cells, and implement mutual recognition of ethical review results. Explore the formulation of relevant standard systems, and carry out pilot clinical transformation applications such as stem cells** and bioartificial liver under the condition of controllable risks.
Zhejiang Province
February 20, 2023
The General Office of the People's of Zhejiang Province issued the Guiding Opinions on Cultivating and Developing Future Industries
The Guiding Opinions put forward the focus on the development of advanced diagnosis and treatment technologies such as cells and genes, stem cells, nuclear medicine, imaging diagnosis, multi-omics data analysis, medical artificial intelligence, artificial tissues and organs, digital drugs and other medical devices and equipment.
Beijing City
February 20, 2023
The Beijing Economic and Technological Development Area issued the "Several Measures of the Beijing Economic and Technological Development Area on Promoting the High-quality Development of the Cell and Gene Industry".
The measures propose to give full play to the advantages of original innovation and clinical resources in the field of cell and gene development in Beijing, closely combine the existing industrial foundation of the development zone, focus on variety development, market application, platform construction, talent gathering, etc., and strive to build the economic development zone into a cell and gene industry gathering area, and accelerate the construction of a global area"Intelligent manufacturing of new drugs"Industrial highland.
September 25, 2023
Nine departments, including the Beijing Municipal Bureau of Economy and Information Technology and the Beijing Municipal Science and Technology Commission, issued the "Several Measures to Support the High-quality Development of the Beauty and Health Industry".
The measures propose to strengthen the protection of innovative intellectual property rights, support the construction of a cosmetics adverse reaction monitoring system, and promote the gathering of high-level enterprises. In particular, it is mentioned that it supports the innovative research and development and application of new cosmetic raw materials. Build a highland for the innovation of new raw materials for cosmetics. Encourage the development of underlying technologies such as gene editing and new cell culture.
Hebei Province
April 7, 2023
The General Office of the People's Government of Hebei Province issued the Action Plan for the Integration of Strategic Emerging Industries in Hebei Province (2023-2027).
The action plan proposes to support and guide Shijiazhuang, Qinhuangdao, Baoding, Langfang and Xiong'an New Area to focus on key areas such as new genomics technologies, gene editing, and cell and gene development, and carry out key technology research such as high-throughput target screening, in vitro gene modification systems, new vector delivery, high-quality source cell preparation, and cell product traceability, accelerate the development and commercialization process of cell and gene drugs, and form industrial agglomeration and synergy in key processes, upstream and downstream core materials, and product development. It also provides safeguard measures from six aspects: strengthening overall coordination, strengthening factor guarantees, accurately attracting investment, enhancing innovation capabilities, strengthening coordination and integration, and cultivating market entities.
Tianjin City
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 this regulation 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 people's needs for health.
Shandong Province
August 28, 2023
Shandong Province issued the "Several Measures to Promote the Innovation and Development of the Cell Industry in the Jinan Area of the China (Shandong) Free Pilot Zone".
Measures to formulate 14 innovation policies from four aspects to promote the high-quality development of Jinan's cell industry.
October 23, 2023
The people of Shandong Province issued the "Several Measures for Further Optimizing the Foreign Investment Environment in Shandong Province and Making Greater Efforts to Attract and Utilize Foreign Investment".
The document includes 23 specific measures in 6 aspects, mentioning that foreign-invested enterprises are encouraged to carry out clinical trials of overseas marketed cell and gene drugs in Shandong in accordance with the law, and optimize the review and approval process for the application for marketing and registration of drugs that have been marketed and produced overseas to be produced in Shandong.
Shanghai
September 18, 2023
The Shanghai Municipal Science and Technology Commission, the Shanghai Municipal Economic and Information Commission, and the Shanghai Municipal Health Commission jointly issued the "Shanghai Action Plan for Promoting Gene Science and Technology Innovation and Industrial Development (2023-2025)".
The program includes 12 major tasks and 8 safeguard measures in 4 aspects, aiming to enhance the ability of innovation source and clinical research transformation in the field of gene technology, and improve the accessibility of gene products and the level of industrial development.
Jilin Province
December 5, 2023
The General Office of the People's Government of Jilin Province issued the "Implementation Plan on Building a New Track for Biomedicine and High-end Medical Device Industry in Jilin Province".
The plan proposes to focus on the development of cell preparation products, the research of cell preparation technology, and the promotion of cell research projects in the field of cell **.