2021最新细胞政策汇总：各地政府纷纷发声，全力推进细胞治疗发展
2021-04-30
In recent years, the State Council has issued relevant policies to support the research of clinical frontier medical technology for cell therapy. Shandong, Guangdong, Anhui, Shanghai, Beijing, Tianjin, Zhejiang, Yunnan, Sichuan, Chongqing and other provinces and municipalities have successively issued plans, programs and support for stem cell transformation research. Opinions promote the development of the cell industry. In 2019, cell therapy was included in my country's industrial structure adjustment guidance catalog for the first time, which will guide cell therapy to accelerate the transformation from laboratory to market.
At the beginning of 2020, in the fight against the new crown pneumonia epidemic, stem cell therapy has once again attracted attention because of its effectiveness and safety. In 2021, policy dividends will continue to be supported, and relevant policies at the national and local levels will be intensively introduced to promote cell therapy. This article will briefly summarize recent cell therapy-related policies so that the industry can pay attention to and know the policy trend~
01Tianjin
According to Tianjin Northnet's report on April 21, after more than half a year of demonstration, the "Report on the Pilot Test of Cell Therapy in Tianjin Free Trade Zone" has been drafted and submitted to the Ministry of Commerce.
Once the pilot is successful, patients can directly enjoy cell diagnosis and treatment methods in the Tianjin Free Trade Pilot Zone and the Linkage Innovation Zone, and scientific research institutions can also let go of research and realize clinical transformation and application more quickly. In the past six years, a total of 477 such system innovations have been completed in the Tianjin Pilot Free Trade Zone. Among them, in 2020, the sixth batch of nationally replicated and promoted experience Tianjin contributed 10 items, ranking first in the country. This year, the Tianjin Pilot Free Trade Zone will make new achievements in the fields of financial leasing, biomedicine, equipment manufacturing, and offshore trade.
02Dalian
The Dalian Free Trade Zone will build a "Gene Cell Therapy Pilot Demonstration Zone" to promote cell therapy in the Dalian Free Trade Zone.
On April 19, the Dalian Free Trade Zone and Dalian Medical University signed a framework agreement to jointly build the "Dalian Gene Cell Therapy Pilot Zone" in the Dalian Free Trade Zone. The two parties will give full play to their respective advantages in policies, talents, technology, resources, etc., focus on cutting-edge fields such as gene cell therapy, and focus on solving industry common problems and "stuck neck" technical problems, and jointly build an internationally renowned and domestically leading highland in the pharmaceutical and life and health industries .
According to the agreement, the two parties will build a cell therapy clinical medical center to promote cell therapy in the Dalian Free Trade Zone. Give full play to the advantages of Dalian Medical University's disciplines, high-level talents and high-level medical care, and focus on in-depth research in the fields of cell therapy, genetic testing, and drug research and development. Explore the establishment of a research and development and achievement transformation model adapted to the characteristics of the Dalian Free Trade Area, strive to realize the transformation and application of key core technologies in the area, and actively carry out foreign cooperation in gene cell therapy.
03Beijing
Beijing Health Commission: Do a good job in the preliminary review of stem cell and somatic cell clinical research institutions and project filings in 2021, and provide important evidence-based support for the promotion of stem cells into clinical applications
In March, the Beijing Municipal Health Commission released the "Key Points of Beijing Municipal Health Science and Education Work in 2021" on its official website. The main points clearly state: do a good job in the preliminary review of stem cell and somatic cell clinical research institutions and project filings, strengthen policy consulting services and pre-application counseling, support filing institutions and enterprises to cooperate in clinical research, and provide an important basis for promoting stem cells to enter clinical applications.证Support.
04Kunming
High-tech Zone issued 16 policies and measures to promote the innovative development of cell industry clusters
In March, the Kunming National High-tech Industrial Development Zone (hereinafter referred to as "Kunming High-tech Zone") cell industry policy release conference and the opening ceremony of the Kunming High-tech Zone Cell Industry Alliance was held. The conference also issued the "Kunming High-tech Zone Promoting the Innovation and Development of Cell Industry Clusters" Policy (Trial)".
"Kunming High-tech Zone Promoting the Innovation and Development of Cell Industry Clusters (Trial)" has introduced 16 policies and measures in seven aspects, including supporting the development of cell industry clusters, promoting the standardization of the cell industry, and supporting the construction of cell industry platforms. The main points of the policy are Kunming The Cell Industry Cluster Innovation Park of the High-tech Zone is the core area and the main gathering area, and strives to promote the development of the cell industry cluster.
05Shenzhen
In March, Director Luo Wenzhi presided over the "Shenzhen Special Economic Zone Cell and Gene Industry Promotion Regulations (Draft)" legislative solicitation forum
Luo Wenzhi pointed out that the city's biomedical industry started early and grew rapidly, but compared with Beijing, Shanghai, Taizhou, Jiangsu and other cities, the enterprise scale and output value are obviously small, and there are shortcomings in industrial development. To do a solid job in the drafting of the Regulations, first, we must emancipate our minds, try first, give play to the role of legislation to lead and promote safeguards, and make good use of the legislative power of the special economic zone and the state grants without conflicting with the basic principles of national laws. The right to experiment with reforms, and breakthroughs in concepts, ideas, and policies and measures; second, relying on enterprises to provide good services to develop cell and gene industries, and financial and related industry authorities must strive to support enterprises to continuously increase R&D and innovation and accelerate key areas Make breakthroughs in key technologies and improve product quality to achieve high-quality development of the industry; third, government departments must strengthen cooperation, focus on the overall situation, and actively participate in the drafting of the "Regulations". The "Regulations" involve various policies and regulations of various national ministries and commissions. A member unit of the drafting leading group must be responsible for drafting relevant clauses, and writing the legal clauses realistically and well.
06Hangzhou
Trends in cell therapy policy! Hangzhou Xiaoshan Area of Zhejiang Free Trade Zone will focus on opening up the approval authority for the clinical and commercialization of cell therapy and gene therapy
In February, the People's Government of Xiaoshan District, Hangzhou City officially released the "Construction Plan for Xiaoshan Block in Hangzhou Area of China (Zhejiang) Pilot Free Trade Zone" on its official website.
The plan clearly puts forward: Explore the first trial of biomedicine. Promote advance trials in biomedicine review and approval, import and export customs clearance, medical services, data and talent element guarantees. Focus on opening up the clinical and commercial approval authority for cell therapy and gene therapy, and explore the establishment of a green channel in the process of application and testing of cell and gene therapy drugs. Support the entry of overseas innovative medical technologies used in clinical research, and pilot the establishment of foreign professional institutions such as foreign-funded medical institutions, health and medical insurance institutions, and health management institutions.
07 Hebei
Hebei Province officially released the "Technical Specifications for Clinical Operation of Cellular Immunotherapy"
The Hebei Provincial Market Supervision Administration organized and formulated the "Technical Specifications for Clinical Operation of Cellular Immunotherapy." This document specifies relevant terms and definitions, basic requirements, risk plans, implementation plan formulation, implementation and operation, treatment of side effects, patient follow-up, etc. This document is applicable to medical institutions and cell preparation institutions that implement cellular immunotherapy. The specification document will be implemented on February 21, 2021.
08 The National Health Commission clarified that the clinical application of stem cells will be managed in accordance with the "Regulations on the Administration of Clinical Research and Transformation of New Biomedical Technologies"!
In February, the official website of the National Health Commission published the "Reply to Recommendation No. 7606 of the Third Session of the Thirteenth National People's Congress."
The reply letter clearly stated: In the next step, the State Council will promulgate the "Regulations on the Administration of New Biomedical Technology Clinical Research and Transformation Application", and the clinical research and transformation application of stem cell technology will be managed in accordance with the relevant provisions of the Regulations.
Up to now, there are more than 100 stem cell research institutions registered with the National Health Commission. The country is also vigorously supporting the clinical transformation of stem cells, and has approved stem cell technology for clinical research in the treatment of dozens of diseases.
Stem cells are currently known in diabetes, leukemia, stroke, Parkinson's and spinal injuries, blood system diseases, nervous system diseases, limb ischemic diseases, cardiovascular and cerebrovascular diseases, secretory system diseases, surgical diseases, skin diseases, tumors and the immune system It is widely used in the treatment of various diseases, and is known as the core technology of the new medical revolution. The development of cell therapy will benefit more patients.
From July 2nd to 3rd, the 2021 International Cell Therapy and Anti-Aging (Shenzhen) Forum will be held at the Shenzhen Convention and Exhibition Center. It will gather top experts and industry scholars in the industry to discuss the latest technology and market development trends in the cell industry. Organize cell therapy and anti-aging exhibitions to help the cell industry build a green channel for communication, exchange and cooperation. People in the industry are welcome to pay attention and participate!
