Another province introduces stem cell clinical research institutions and filing policies

What conditions should be met by research institutions and staffing personnel For stem cell clinical research institutions, the Regulations specify that complete stem cell quality control conditions, comprehensive stem cell clinical research quality management system and independent stem cell clinical research quality assurance department; For staffing, the Regulations require that the person in charge of the stem cell clinical research project and the person authorized by the person responsible for the quality of the preparation should be formally authorized by the principal person in charge of the institution, with a positive professional and technical title, with good scientific research reputation, and the main researchers have been trained in the Quality Management Practice of Drug Clinical Trials (GCP) and obtain the corresponding qualificationsFor the filing conditions for stem cell projects, the Regulations state that stem cell clinical research must have sufficient scientific basis and that the prevention or treatment of diseases is better than existing means, or for diseases that do not have effective interventions, diseases that threaten life and seriously affect the quality of life, and major medical and health needsStem cell clinical research should comply with the requirements of the Code of Quality Management of Drug Clinical Trials, and stem cell preparations meet the requirements of the Guidelines for Quality Control of Stem Cell Preparations and Preclinical Research (Trial)To complete the project project before filing, the institution shall complete the academic and ethical examination of the project in accordance with the procedures and related work systems for the stem cell clinical research projectIt can be seen that, in fact, there is no new breakthrough in the filing of stem cell clinical research institutions and projects in Fujian Province, which is implemented in accordance with the "standard" provisions of national policy"Double filing" system In early 2019, the National Health and Health Commission and the State Drug Administration jointly issued the "Notice on doing a good job in the supervision and management of stem cell clinical research in 2019" clear: In 2019, the National Health And Health Commission, the State Drug Administration will continue to organize a quarterly review of stem cell clinical research institutions and project filing materialsStarting from 2019, stem cell clinical research institutions and project filings will be dynamically managed, and if the recorded stem cell clinical research institutions still have no research projects to file by the end of 2020, they shall resubmit the filing materials of the institutions, and those who fail to perform the procedure of resubmitting the filing materials shall be deemed to be automatically abandoned for filingIn the future, stem cell clinical research institutions and project filings will be combinedInstitutions to conduct clinical research on stem cells shall, after examination by the provincial health and safety administrative departments and the drug regulatory departments, report the complete institutional filing materials and project filing materials to the National Health And Health Administration and the State Drug Administration for the recordOn March 29, 2019, the Health and Health Commission issued the Measures for the Administration of Clinical Research and Conversion Applications in Somatic Cell Therapy (Trial) (Draft for Comments), which clearly requires that, in accordance with the relevant provisions of these Measures, medical institutions carrying out clinical research and conversion applications for somatic cell therapy should be filed, and medical institutions shall provide the filing materials and clinical research projectfiling materials for the first timeIn other words, the state has increased the supervision of stem cell research, regulated 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" systemUp to now, Lanzhou University First Hospital, Zhengzhou City First People's Hospital, Guangzhou Medical University affiliated second hospital and Shulan (Hangzhou) Hospital has completed the "double filing." In September 2019, two stem cell clinical research institutions and 11 stem cell clinical research projects were filed in accordance with the regulations of the Measures for the Management of Stem Cell Clinical Research (Trial) (No48 of THE National Health And Science Administration (2015) and the Notice on the Supervision and Administration of Stem Cell Clinical Research in 2019 (No169 of the State Health Administration's Science and Education Letter (2019) noSo far, the number of state-approved stem cell clinical treatment research hospitals has increased to 106, and the number of hospitals in the military system has been approved for a total of 12 institutions, with a total of 118 institutions, and the number of filing projects has increased to 62Global has been listed 18 products In terms of product end, stem cell therapy as one of the most important treatment sourcing at this stage, so far, a total of 18 stem cell products have been approved for market, involving indications including knee osteoarthritis, acute heart attack, degenerative arthritis, transplant resistance Host disease, Crohn's disease, Heller syndrome, thromboclines, membrane stem cell deficiency, adenosine deaminase deficiency, Buergers disease caused by severe limb ischemic disease, these products are mainly interstitial stem cells, No related products have been approved in ChinaAt this stage, stem cells according to the drug, technology management of the "two-track" supervision, enterprises of stem cell preparations to encourage the declaration of drugs, enterprises to encourage the declaration of stem cells according to drugs, the State Food and Drug Administration (NMPA) supervision; According to insight database declaration registration plate information, stem cell therapy since 2012 was called off, after 6 years, 2018 CDE again opened the stem cell drug registration acceptance channel, so far, there are 9 new stem cell drugs in China IND application by the National Drug Review Center (CDE) officially accepted, in addition to Jiangxi Xianho Medical Technology Co., Ltd independent research and development of ENDREG001 cell self-incarcation preparation for the sub-body lung base of the endothelious endothelico cell, 8 other stem cells At the same time, there are 4 new stem cell drugs IND has been clinically implied permission, respectively, placenta, umbilical cord, allogeneic / self-contained fat source of interstitial stem cells, indications are diabetic foot ulcer, knee osteoarthritis and knee osteoarthritis Among them, Sibiman Biotech (Shanghai) Co., Ltd has clinically implied licenses for two new stem cell drugs, including CBM-ALAM.1 allojoining interstitial interstitial protocellular injections (AlloJoin?) And self-induced inter-fat-filled protocyte injections (ReJoin?), are used to treat knee osteoarthritis Fujian Stem Cell Clinical Research Institutions and Projects Filing Implementation Rules (Trial) Chapter 1 General Rules For the record of stem cell clinical research institutions and projects, regulate the work of stem cell clinical research, and formulate these Regulations in accordance with the Measures for the Management of Stem Cell Clinical Research (Trial) (No 48) and the Guiding Principles for Quality Control and Preclinical Research of Stem Cell Preparations (Trial) (State Health Administration Science and Education (2015 46) Article 2 These Rules shall apply to the filing management of institutions and projects (hereinafter referred to as institutions and projects) to conduct clinical research on stem cells Chapter II Conditions For filing Article 3 Stem Cell Clinical Research Institutions shall have the following conditions: (1) Grade III A hospitals shall have the corresponding diagnostic subjects corresponding to the stem cell clinical research conducted (2) To obtain the qualification of the relevant professional clinical trial institution for drugs in accordance with the law (3) Has a strong comprehensive medical, teaching and scientific research capability, undertakes major research projects in stem cell research, and has a legitimate source, relatively stable and adequate project research funding support (4) Have complete stem cell quality control conditions, a comprehensive quality management system for stem cell clinical research and an independent quality assurance department for stem cell clinical research, establish a system of recipients of the quality of stem cell preparations, have complete quality management and risk control procedures and related documents (including quality management manuals, clinical research procedures, standard operating procedures and test records), and have a system of audit of stem cell clinical research, including qualified internal audit personnel and internal audit and external audit system (5) The person in charge of the stem cell clinical research project and the person authorized for the quality of the preparation shall be formally authorized by the principal person in charge of the institution, with a positive senior professional and technical title, and with good scientific research reputation The lead researchers are trained in the Code of Quality Management (GCP) in Drug Clinical Trials and are qualified accordingly Institutions should be equipped with sufficient qualified human resources to conduct corresponding stem cell clinical research, develop and implement training programs for stem cell clinical researchers, and monitor the effectiveness of training (6) Having an academic committee and an ethics committee composed of high-level experts that is appropriate to the clinical research on stem cells conducted (7) Measures to prevent the risk of clinical research on stem cells and measures to deal with adverse reactions and events Article 4 The conditions for filing a stem cell research project A stem cell research project shall be carried out in an institution that has been filed Project filing and institutional filing may also be conducted at the same time Stem cell research projects should have the following conditions: (i) stem cell clinical research must have sufficient scientific basis and the effectiveness of disease prevention or treatment is superior to existing means, or for diseases that do not have effective interventions, for life-threatening and critical quality-of-life diseases, and for significant medical and health needs (2) The clinical study of stem cells shall comply with the requirements of the Code of Quality Management of Drug Clinical Trials Stem cell preparations meet the requirements of the Guidelines for Quality Control of Stem Cell Preparations and Preclinical Research (Trial) (3) The preparation of stem cell preparations shall conform to the basic principles and relevant requirements of the Code of Quality Management for Pharmaceutical Production (GMP), be equipped with appropriately qualified personnel, applicable facility equipment and complete quality management documents, and the original auxiliary materials, preparation process and quality control shall comply with the relevant requirements (4) To complete the project project work before the project is filed, the institution shall complete the academic and ethical examination of the project in accordance with the procedures and related working systems for the research project sand Chapter III Filing Materials Article 5 Main submission materials of stem cell clinical research institutions: (1) a copy of the medical institution's license to practise; (2) a copy of the certificate of qualification of the drug clinical research institution; (3) the management system of the organization's stem cell clinical research organization (framework) and the responsibilities of various departments; (4) the primary responsibility for the management of stem cell clinical research in an institution, the qualification of the quality grantee, and the training of relevant personnel; (5) The composition of the academic committee of the institution and the working system and standard operating norms; (6) the standard operating procedures for stem cell preparation and the equipment and personnel conditions of the facilities; (7) the quality management and risk control procedures and related documents of the stem cell clinical research (including quality management manuals, clinical research procedures, standard operating procedures and test records, etc.); (8) the internal audit system of the stem cell clinical research, the internal audit system, the audit system, the internal audit ingenuity system, the qualification of the internal audit personnel; Measures for adverse events; (11) other relevant information Article 6 The stem cell clinical research project shall submit the following materials: (1) the project declaration material signed in good faith commitment (ii) Application form for project ethics review (see annex 3) (iii) Funding for clinical research (iv) List and resume of researchers (including clinical research units and preparation development units), stem cell clinical research quality management manual (v) The criteria for the selection of the supplier and the sample draft of the donor's informed consent form (6) The main raw material standards in the process of stem cell preparation (7) The preparation process of stem cell preparations, quality control standards and the basis for development, as well as process stability data (viii) A complete record of stem cell preparation and a quality test report on stem cell preparation (9) Tracing programmes for the labelling, storage, transport and use of stem cell preparations (10) Measures for the treatment of non-conforming and residual stem cell preparations (11) Preclinical studies, including cell level and evaluation of safety and effectiveness of animal experiments (12) The clinical research plan shall include 14 items such as research topic, research purpose, basis for the establishment of the topic and expected effect (13) Clinical research risk prediction and treatment measures, including risk assessment reports, control plans and implementing rules (14) Clinical research schedule (15) Measures for the recording and preservation of information (16) Sample form of the subject's informed consent form (17) Researcher's handbook (18) Relevant documents on intellectual property rights (19) Approval of academic review opinions and ethics review by the Academic Committee of the Institutional Academic Committee (see Annex 4) (20) other relevant materials Chapter IV Filing Procedure Article 7 Stem cell clinical research institutions and project filings are conducted in combination, dynamic management is implemented, and quarterly regular records are filed Submissions are submitted to the province in the first month of each quarter, submitted to the state in the second month after the provincial audit, and filed by the National Stem Cell Expert Committee in the third month (1) Declaration of materials Institutions applying for clinical research on stem cells shall, with a complete institutional filing material and project filing materials, print a two-part and electronic cd-ROM with A4 paper on double-sided printing, and report them to the Provincial Health and Health Commission's Science and Education Department At the same time, the network ( to fill in the organization, project filing information collection form (ii) Expert review The provincial health and health committee, together with the provincial drug regulatory bureau, organizes the provincial expert committee on clinical research of stem cells and the committee of ethics experts to conduct a formal review of the material, which may, if necessary, conduct on-site verification, and issue examination opinions and expert opinions (iii) Reporting The provincial health and health committee will review the declaration materials one and electronic version of the CD-ROM, together with the views of the provincial committee of experts to the National Health And Health Commission The details of the flowchart can be found in Annex 1 Chapter V Supervision and Management Article 8 Stem cell clinical research institutions shall bear the main responsibility for research, the principal person in charge of the institution shall be fully responsible for the research work, shall strengthen the sense of the responsible subject, conscientiously fulfill the quality management of stem cell preparations and clinical research, further establish and improve the internal rules and regulations of the institution, strengthen the management of personnel education and research projects, strictly implement the research report system and inspection system, carefully analyze and solve the problems arising in the research process, and ensure that the stem cell clinical research is conducted in an orderly manner Article 9 The Provincial Health and Health Commission and the Provincial Drug Administration shall strengthen the supervision and management of stem cell clinical research institutions and projects filed in their jurisdictions, establish a working mechanism for special inspection sandchecks and random spot checks, and, if necessary, carry out extended verification of stem cell preparation units Chapter VI By-laws Article 10 These Rules shall be interpreted by the Provincial Health and Health Commission and the Provincial Drug Administration Article 11 These Measures shall come into effect as of the date of publication Texts Medical Valley Comprehensive Report