Another province introduced stem cell clinical research institutions and filing policies

Recently, Fujian health and Health Commission issued the notice on the detailed rules for the implementation of stem cell clinical research institutions and project registration (Trial) (hereinafter referred to as the detailed rules for Implementation), which specifically required the registration institutions and projects of stem cell clinical research in the province For the conditions that should be met by the clinical research institutions of stem cells, the detailed rules for implementation clearly states that they need to have complete quality control conditions for stem cells, a comprehensive quality management system for clinical research of stem cells and an independent quality assurance department for clinical research of stem cells; establish a quality authorized person system for stem cell preparations; and have a complete quality management system for the whole process of preparation and clinical research of stem cell preparations Management and risk control procedures and relevant documents (including quality management manual, clinical research work procedures, standard operation specifications, test records, etc.); with stem cell clinical research audit system, including qualified internal auditors and internal and external audit systems For personnel allocation, the implementation rules requires that the person in charge of stem cell clinical research project and the person authorized for preparation quality shall be officially authorized by the principal of the institution, have senior professional and technical titles, and have good scientific research reputation; the main researchers shall be trained in GCP and obtain corresponding qualifications As for the filing conditions of stem cell project, the detailed rules of implementation put forward that the clinical research of stem cell must have sufficient scientific basis, and the effect of prevention or treatment of diseases is better than the existing means; or it can be used for diseases without effective intervention measures, diseases that threaten life and seriously affect the quality of life, and major medical and health needs The clinical research of stem cells shall meet the requirements of the "quality management specification for clinical trials of drugs", and the stem cell preparations shall meet the requirements of the "guidelines for quality control and preclinical research of stem cell preparations (Trial)" Project approval shall be completed before project filing, and the institution shall complete academic and ethical review of the project in accordance with the review procedures and relevant work systems of stem cell clinical research project approval It can be seen that in fact, there is no new breakthrough in the registration of stem cell clinical research institutions and projects in Fujian Province, which are implemented in accordance with the "standard configuration" provisions of national policies At the beginning of 2019, the national health and Health Commission and the State Drug Administration jointly issued the notice on doing well in the supervision and management of stem cell clinical research in 2019 It is clear that in 2019, the national health and Health Commission and the State Drug Administration will continue to organize the review of stem cell clinical research institutions and project filing materials once a quarter Since 2019, stem cell clinical research institutions and project filing will be subject to dynamic management If the filed stem cell clinical research institutions still have no research project filing by the end of 2020, they shall re submit the institutional filing materials, and those who fail to fulfill the re submission of filing materials procedure shall be deemed to automatically give up the filing In the future, stem cell clinical research institutions and project filing will be carried out in combination The institutions that intend to carry out stem cell clinical research shall submit the complete institution record materials and project record materials to the National Health Commission and the State Food and Drug Administration for the record after being reviewed by the provincial health administration department and the drug regulatory department On March 29, 2019, the health care Commission issued the measures for the administration of clinical research and transformation application of somatic cell therapy (Trial) (Draft for comments) The interpretation document clearly requires that: according to the relevant provisions of these measures, medical institutions carrying out clinical research and transformation application of somatic cell therapy should be put on record, and medical institutions should provide medical machines at the same time when they are putting on record for the first time To establish filing materials and clinical research project filing materials In other words, the state has increased the supervision of stem cell research, standardized the stem cell clinical research system, and implemented the stem cell clinical research institution filing and stem cell clinical research project filing, also known as the "double filing" system Up to now, the first hospital of Lanzhou University, the first people's Hospital of Zhengzhou, the Second Affiliated Hospital of Guangzhou Medical University and Shulan (Hangzhou) hospital have completed the "double filing" In September 2019, in accordance with the provisions of the measures for the administration of stem cell clinical research (Trial) (Guo Wei Ke Jiao Fa [2015] No 48) and the spirit of the notice on the supervision and management of stem cell clinical research in 2019 (Guo Wei ban Ke Jiao Han [2019] No 169), another 2 stem cell clinical research institutions and 11 stem cell clinical research projects completed the filing So far, the number of national approved stem cell clinical treatment research hospitals has increased to 106, the number of military approved hospitals has increased to 12, a total of 118 institutions, and the number of registered projects has increased to 62 In terms of product end, stem cell therapy is one of the important treatment methods at this stage Up to now, there are 18 kinds of stem cell products approved for market in the world, including knee osteoarthritis, acute myocardial infarction, degenerative arthritis, graft-versus-host disease, Crohn's disease, Heller's syndrome, thromboangiitis obliterans, membranous stem cell deficiency Adenosine deaminase deficiency, serious limb ischemia caused by Buergers disease, etc these products are mainly mesenchymal stem cells, and no relevant products have been approved in China At this stage, stem cells are supervised according to the "dual track system" of drug and technology management, enterprises' stem cell preparations are encouraged to declare according to drugs, enterprises' stem cell preparations are encouraged to declare according to drugs, supervised by the State Food and Drug Administration (nmpa); new biomedical technology led by medical institutions, namely hospital preparations can be managed according to medical technology, supervised by the health care Commission According to the information of the application and registration section of insight database, stem cell therapy was stopped in 2012, and after six years, CDE opened the acceptance channel for stem cell drug registration again in 2018 Up to now, nine ind applications for new stem cell drugs in China have been officially accepted by the national drug review Center (CDE) In addition to the regend001 cell self-developed by Jiangxi Xianhe Medical Technology Co., Ltd The other 8 types were mesenchymal stem cells At the same time, four new stem cell drugs, ind, have been approved clinically They are placenta, umbilical cord, mesenchymal stem cells derived from allogeneic / autogenous fat The indications are diabetic foot ulcer, knee osteoarthritis and knee osteoarthritis Among them, sibyman Biotechnology (Shanghai) Co., Ltd has two tacit clinical licenses for new stem cell drugs, including cbm-alam 1 allogeneic human adipose mesenchymal progenitor cell injection (allojoin?) and autogenous human adipose mesenchymal progenitor cell injection (rejoin?), which are used to treat knee osteoarthritis Detailed rules for the implementation of filing (Trial) Chapter I General Provisions Article 1 in order to do a good job in the filing of stem cell clinical research institutions and projects, and standardize the clinical research of stem cells, these implementation rules are formulated in accordance with the measures for the management of stem cell clinical research (Trial) (gwkjf [2015] No 48) and the principles for quality control and preclinical research guidance of stem cell preparations (Trial) (gwbkjf [2015] No 46) Article 2 These Detailed Rules are applicable to the filing management of institutions and projects (hereinafter referred to as institutions and projects) to carry out stem cell clinical research Chapter II filing conditions Article 3 stem cell clinical research institutions shall meet the following requirements: （1） The third class a hospital has the diagnosis and treatment subjects corresponding to the stem cell clinical research carried out by it （2） According to the law, the company has obtained the qualification of drug clinical trial institutions of relevant specialties （3） It has strong comprehensive abilities in medical treatment, teaching and scientific research, undertakes major research projects in the field of stem cell research, and has legal, relatively stable and sufficient project research funding support （4） Have complete stem cell quality control conditions, comprehensive stem cell clinical research quality management system and independent stem cell clinical research quality assurance department; establish stem cell preparation quality authorized person system; have complete quality management and risk control procedures and relevant documents (including quality management manual and clinical research) in the whole process of stem cell preparation and clinical research Work procedures, standard operation specifications, test records, etc.); have a stem cell clinical research audit system, including qualified internal auditors and internal and external audit systems （5） The person in charge of stem cell clinical research project and the authorized person of preparation quality shall be officially authorized by the principal of the institution, with senior professional and technical titles and good scientific research reputation The main researchers were trained in GCP and got corresponding qualification Institutions shall allocate sufficient qualified human resources for stem cell clinical research, formulate and implement training plans for stem cell clinical researchers, and monitor the training effect （6） It has an academic committee and an ethics committee composed of high-level experts suitable for the clinical research of stem cells （7） It has the management mechanism to prevent the risk of stem cell clinical research and measures to deal with adverse reactions and events Article 4 conditions for filing stem cell research projects Stem cell research projects shall be implemented in the institutions that have been put on record Project filing and institutional filing can also be carried out at the same time Stem cell research projects should meet the following requirements: （1） Stem cell clinical research must have sufficient scientific basis, and the effect of prevention or treatment of diseases is better than the existing means; or for diseases without effective intervention measures, for diseases that threaten life and seriously affect the quality of life, as well as major medical and health needs （2） The clinical research of stem cells should conform to the requirements of the quality management standard for clinical trials of drugs Stem cell preparations meet the requirements of "guidelines for quality control and preclinical research of stem cell preparations (Trial)" （3） The preparation of stem cell preparations shall comply with the basic principles and relevant requirements of the GMP, be equipped with appropriately qualified personnel, applicable facilities and equipment and complete quality management documents, and the raw and auxiliary materials, preparation process and quality control shall comply with the relevant requirements （4） Project approval shall be completed before project filing, and the institution shall complete academic and ethical review of the project in accordance with the review procedures and relevant work systems of stem cell clinical research project approval Chapter III filing materials Article 5 main materials submitted by stem cell clinical research institutions: （1） Photocopy of practice license of medical institution; （2） Copy of qualification certificate of drug clinical trial institution; （3） Organization and management system of stem cell clinical research and responsibilities of each department; （4） Qualification of main responsible person and quality authorized person of stem cell clinical research management, and training of relevant personnel; （5） The composition of Academic Committee and ethics committee, their working system and standard operation standard; （6） Standard operating procedures for stem cell preparation, facilities, equipment and personnel conditions; （7） Stem cell clinical research quality management and risk control procedures and related documents (including quality management manual, clinical research work procedures, standard operation specifications and test records, etc.); （8） Stem cell clinical research audit system, internal and external audit system, internal auditor qualification; （9） Stem cell quality evaluation standards and testing equipment and facilities; （10） Management mechanism of preventing clinical research risk of stem cells and dealing with adverse reactions