According to the Beijing Municipal Health Planning Commission reported on the 22nd, Beijing recently met with relevant departments, organized 12 clinical research institutions for stem cell research, convened on-site meeting of stem cell clinical research supervision and inspection, and proposed specific aspects for controlling the quality and risk management of stem cell clinical research. Claim. On January 13th, a number of immunotherapy product declaration clinical and cell therapy product technical guidelines were released, and was rated as the top ten progress of China's pharmaceutical biotechnology in 2017. Why is this guiding principle being looked forward to by the entire industry, and what are the things clear? Say "yes" to the treatment of cancer and genetic diseases Since the release of the "Guidelines for the Research and Evaluation of Cellular Products" (Draft for Comment) in December 2016, cell therapy products have been waiting for the opening of the clinical door, giving "yes" answers for cancer treatment and genetic disease treatment. . Until December 18, 2017, the State Food and Drug Administration issued the "Guidelines for the Research and Evaluation of Cellular Therapeutic Products (Trial)", which was rated as "boots finally landing" by the industry. From the name of the final published document, the original "cell product" was changed to "cell therapy product", and it can be seen that the guiding principle is intended to promote the application of related therapies. “The release of the Guiding Principles has made cell therapy a step closer to the goal of clinical products,†said Yang Guanghua, the founder of the national “Thousand Talents Program†and the founder of Bion Bio. This means that if the cell products of the applicant company meet the requirements, After clinical trials have proved effective, it should be approved soon, and cell treatment "landing" will not be far away. Since the end of August 2017, the US FDA has approved Novartis's cellular immunotherapy market, China's industry has been full of expectations for the listing of cell therapy, the State Food and Drug Administration issued the "Technical Guidelines for Research and Evaluation of Cellular Therapeutic Products (Trial)" That means the door to the clinic has finally opened. Higher levels of controllability in terms of safety, effectiveness and quality “The original ambiguous operation has clear standards,†said Yang Guanghua. “The previous industry standards were the requirements of industry associations. They were spontaneous constraints. Some teams were stricter than industry standards, and some might not be as good as team standards.†The implementation of the standard further regulates the research and development of cell therapy products, improves their safety, effectiveness and quality controllability, and promotes and promotes the healthy development of cell therapy in China. "Because of the particularity of cell therapy products, the evaluation system of new drugs was difficult to apply." Yang Guanghua said, "Pills are dead, cells are alive, such as stem cells, which breed and produce different 'algebra', different algebra The cell's dryness is different and its therapeutic functionality will vary." Cell treatment products are also very different from pharmaceuticals at the time interval from preparation to use. "The shelf life of the tablets can be several years, and the cell products are prepared in the morning, and the patients can be returned in the afternoon, but the quality control test results may come out tomorrow. What should I do?" Due to the great difference from the drug, the immune cell therapy products in the previous cell therapy products have been managed according to the “third class medical technologyâ€, and the industry also has two different management sounds according to “new drug†and “medical technologyâ€. The publication of the "Guiding Principles" clarifies that cell therapy products are administered in accordance with the "new drug" declaration. “Choose this road more rigorously to ensure safety, effectiveness and quality controllability.†Yang Guanghua said. In view of the characteristics of individualization and timeliness of cell therapy products, the “Guiding Principles†not only stipulate strict production processes and operation specifications, but also introduce solutions to the precautions. The document states: It is recommended to complete all the products before clinical application. Release test, when some release test results may be post-set, a disposal plan should be prepared for possible unanticipated test results. In addition, the cell product itself has the characteristics of being easily polluted and unable to tolerate the inactivation of virus bacteria, and strengthening process control has become the focus of production specifications. In the relevant interpretation of the Food and Drug Administration, “full monitoring†is emphasized. Every production step of cell therapy products should be researched and verified to ensure the rationality and stability of the process. "At the same time, we must formulate a plan, and if there is pollution or access to pathogens, we must have a plan to deal with it." Yang Guanghua said. Digital specification of specific indicators In addition to the control of the entire process, the quality control of cell products is divided into two ends. Yang Guanghua introduced, “Quality control including both raw materials and finished products.†The Guiding Principles also clarify the previous ambiguity, such as how to evaluate the tumorigenicity and carcinogenicity of cell therapy products. This is an estimated proposition because some of the growth factors used in the treatment process may cause tumors in the host cell or cell treatment product itself, although traditional carcinogenicity tests may not be suitable for cell therapy products, but no scientific consensus has yet been reached. This guiding principle still uses tradition. For another example, according to the previous approval process for new drug reviews, effective treatments have been made on the human body, and sometimes it is necessary to return to the verification of animal experiments, which is unreasonable for the research team. The principle clarifies that “human data can be used to demonstrate the effectiveness and safety of cell treatment products after scientific evaluation, and to ensure the safety of clinical subjects, unnecessary animal tests can be dispensed withâ€. “There will be more clear and detailed requirements in the future,†Yang Guanghua said. “For example, give a digital specification for specific indicators such as activity and subject matter.†(Science and Technology Daily) Vital Signs Monitor,Pulse Oximeter,Oxygen Concentrator,Patient Monitor,valve inflatable extension tube Anesthesia Medical Co., Ltd. , https://www.sinoanesthesia.com