Medical Network April 1st, March 29, 2019, the National Health and Health Commission Office of the Department of Solicitation of Clinical Research and Transformation Application Management (Trial) (Consultation Draft). It clearly states: the management of the somatic cell clinical research, and allows clinical research to prove that safe and effective somatic cell treatment projects have been filed in relevant medical institutions for conversion applications.
1. What is the background for the development of the "Clinical Cell Therapy Clinical Research and Transformation Application Management Measures (Trial)"?
In recent years, with the rapid development of health and wellness technology, cell therapy has brought new hopes for patients with refractory diseases such as malignant tumors, certain infectious diseases and genetic diseases, and in many ways in developed economies such as the United States, Europe and Japan. Beginning to enter clinical applications, China's medical institutions have also carried out a large number of clinical research, and patients are eager to receive high-quality cell therapy.
In order to meet clinical needs, standardize and accelerate the development of cell therapy science, the National Health and Health Commission has drafted this management method, documented the management of somatic cell clinical research, and allowed clinical research to prove that safe and effective somatic cell treatment projects have been filed in relevant medical care. The organization enters the conversion app.
2. What is the relationship between this management method and the management method for stem cell clinical research?
The scientific definition of somatic cells includes stem cells. The former National Health and Family Planning Commission and the former General Administration of Food and Drug Administration issued the "Cell Cell Clinical Research Management Measures (Trial)" in 2015, effectively regulating and promoting the clinical research work of stem cell therapy in China. Management Measures “Article 31, somatic cell therapy with special management methods shall be implemented in accordance with current regulationsâ€, and relevant work on stem cell clinical research is still carried out in accordance with the provisions of the “Cell Cell Clinical Research Management Measures (Trial)â€.
3. What is the scope of application of the management measures?
Article 3 of the Administrative Measures stipulates that “the present Measures shall apply to clinical research and transformation applications of somatic treatment developed, prepared and carried out in medical institutions by medical institutionsâ€. The National Health and Health Commission carried out catalogue management of cell therapy conversion application projects, and misaligned the development of cell therapy products with obvious industrialization prospects. The somatic cell treatment products researched and developed by the enterprise shall be reported to the national drug regulatory authority for registration and listing in accordance with the relevant provisions on drug administration.
Fourth, how to carry out somatic treatment?
In accordance with the relevant provisions of the Administrative Measures, medical institutions that carry out clinical research and transformation applications for somatic treatment should be filed. When the medical institution conducts the first institutional filing, it must also provide medical institution filing materials and clinical research project filing materials. When a newly registered clinical research project is added to a medical institution that has been filed, only the clinical research project filing materials must be submitted. After the completion of the somatic cell therapy clinical research project carried out by the medical institution, on the basis of obtaining evidence of safety and effectiveness, the transformation application can be filed, and the somatic cell clinical research project is transferred to the transformation application in the medical institution.
The medical institution shall register and upload a scanned copy of the relevant materials in the filing information system, and submit the paper quality to the provincial health and health administrative department. The provincial health and health administrative department shall complete the formal review and submit it to the National Health and Health Commission within 15 days from the date of receipt of the filing materials. The National Health and Health Commission shall organize an evaluation committee of the Somatic Cell Therapy within 2 months from the date of receipt of the filing materials, and publicize the list of medical institutions and clinical research or transformation application projects that have been filed and accept social supervision. If the investigation fails to meet the conditions for filing, the filing materials may be submitted again after rectification, and the rectification period shall be no less than 6 months.
5. How is the clinical research project for somatic cell therapy being carried out?
These measures shall be applied to the management of medical institutions that are conducting clinical research on somatic cell therapy, and shall perform the filing procedures within 30 working days from the date of promulgation of these Measures. The National Health and Health Commission organizes experts to conduct supervision and inspection, and suspend or terminate opinions on medical institutions and their research projects that do not meet the requirements. If the conditions are met, the research can continue.
6. What are the general requirements for somatic cell clinical research into transformation applications?
On the basis of obtaining evidence for the safety and efficacy of somatic treatment in clinical research, summarizing the treatment options and technical standards for a certain disease (indications) (including the type/pathway of cell therapy, therapeutic dose/time and course of treatment, etc.) ).
Through the transformation of the academic committee of the institution, the evaluation review and the ethics review of the ethics committee. A comprehensive evaluation program for the application of somatic cell therapy transformation. After filing, you can enter the conversion application in the medical institution that conducts clinical research.
7. How to do the process supervision of clinical research and transformation application of somatic cell therapy?
The National Health and Health Commission shall conduct spot checks, special inspections or cause inspections on the registered medical institutions and projects by means of flight inspections, and publicize the inspection results. The provincial health and health administrative department shall carry out the daily supervision and management of the clinical research and transformation application of the somatic treatment in the medical institutions under its jurisdiction, and submit the supervision and management work report to the National Health and Health Committee every year.
Where a medical institution carries out the provisions of Article 28 of the somatic cell clinical research and transformation application, the provincial health and health administrative department shall order it to suspend the clinical research or transformation application project of somatic cell therapy, and the rectification period is not less than 6 months, and Report the relevant situation to the National Health and Health Commission; if there is a situation as stipulated in Article 29, the National Health and Health Commission will order it to stop the clinical research and transformation application of somatic treatment, report it to the public, and deal with it in accordance with the relevant laws and regulations .
8. Can I charge for clinical research and conversion applications for somatic cell therapy?
The study of somatic cell therapy should not charge the subject any research-related costs. After the application of the somatic cell therapy conversion application project can be transferred to clinical application, the medical institution applying for filing shall follow the notice of the National Development and Reform Commission and other four departments on the issue of proposing the reform of medical service price reform (Development and Reform Price [2016] No. 1431) For the relevant requirements, apply for a fee to the local provincial price authority.
Dried fruit products as the name implies, dried fruit products are pre-treated fruits after selection, washing and dehydration to the water content of 15 ~ 25% products. The volume of dried fruit is about 11 ~ 31% of that of Fresh Fruit, and the weight is about 10 ~ 25% of that of fresh fruit, so it can significantly save the cost of packaging, storage and transportation, and it is easy to eat and carry. Common dried fruits are raisins, red dates, dried mango, dried kiwi, dried strawberry and so on.
Dried Fruit,Dried Mango,Raisins,Red Dates,Dried Kiwi,Dried Strawberry
Xi'an Gawen Biotechnology Co., Ltd , https://www.agolyn-bio.com