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A selection of major information about the cell in January
The state clearly encourages the development of the cell industry! Issued the "Industrial Structure Adjustment Guidance Catalogue (2024 Edition)".
The state issued the "Guiding Catalogue for Industrial Structure Adjustment (2024 Edition)", which will come into force on February 1, 2024. Among them, under the encouraged pharmaceutical sector, many fields involve the development of the cell industry, including encouraging large-scale and efficient cell culture and purification, gene and cell drugs, chemical composition limited cell culture media, high-end, intelligent pharmaceutical equipment, etc.
China's first "silver economy" policy was introduced, and the anti-aging industry and regenerative medicine were named
On January 15, the General Office of ** issued the "Opinions on Developing the Silver Economy and Improving the Well-being of the Elderly", which is the first special document issued by the state to support the development of the silver economy. In the document, the development of anti-aging industry and regenerative medicine was once again named, emphasizing the deepening of the research and development and application of high-precision technology in the field of anti-aging, promoting the deep integration of biotechnology and delaying geriatric diseases, and developing early screening products and services for geriatric diseases.
CDE released "Non-clinical Research on Human Stem Cell Products".Technical Guiding Principles", effective as of the date of promulgation
On January 18, the Center for Drug Evaluation (CDE) of the State Food and Drug Administration issued the "Technical Guidelines for Non-clinical Research of Human Stem Cell Products", which mainly provides technical guidance for the non-clinical research of human stem cell products for R&D and registration declaration in accordance with relevant regulations on drug administration.
The human stem cell products in the guiding principles refer to stem cells and their derived cell products that originate from human adult stem cells, human embryonic stem cells and induced pluripotent stem cells and are obtained through a series of in vitro operations involving stem cells (generally including expansion, gene modification, induced differentiation, transdifferentiation, etc.).
Seven departments issued a document to comprehensively lay out six future industries, and cell and gene technology became the focus
On January 29, in order to implement the spirit of the 20th National Congress of the Communist Party of China and the "Outline of the 14th Five-Year Plan for National Economic and Social Development of the People's Republic of China and the Long-Range Objectives Through the Year 2035", the Ministry of Industry and Information Technology, the Ministry of Education, the Ministry of Science and Technology and other seven departments jointly issued the "Implementation Opinions on Promoting the Innovation and Development of Future Industries" (hereinafter referred to as the "Opinions") to strengthen the forward-looking planning and policy guidance of future industries, support and promote new industrialization, and accelerate the formation of new quality productivity.
The document mentions that it will focus on promoting the development of industries in six directions: future manufacturing, future information, future materials, future energy, future space and future health. Among them, "accelerating the industrialization of cell and gene technology" is listed as the focus of the future health industry!
CDE issued the "Technical Guidelines for Clinical Trials of Mesenchymal Stem Cells for the Prevention and Treatment of Graft-versus-Host Disease".
On January 18, CDE released the "Technical Guidelines for Clinical Trials of Mesenchymal Stem Cells for the Prevention and Treatment of Graft-versus-Host Disease". The purpose of these guidelines is to provide research suggestions on clinical trials of mesenchymal stem cells for the prevention and treatment of graft-versus-host disease for sponsors who carry out the research and development and registration application of mesenchymal stem cell products in accordance with the Drug Administration Law of the People's Republic of China, the Measures for the Administration of Drug Registration and other relevant laws and regulations on drug administration.
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