Research base of the stem cell clinical trials management approach (trial) "(draft)

The ministry of health of the People's Republic of China: www.moh.gov.cn

        To strengthen supervision and management of clinical trials of stem cell research and ensure that stem cell clinical trials at a high level of specification of medical institutions to carry out, in 2012, the ministry of health and state food and drug administration clinical stem cell research and application specification rectification work leading group organization expert committee of research made the research base of the stem cell clinical trials management approach (trial) "(hereinafter referred to as the" management method base "), through repeated discussion, modification, has form the draft, and in March 2013 for advice throughout the country. Interpretation will now about the problem are as follows:

        A, why want to formulate measures for the administration of the base?

        Rapid development in recent years, stem cell research in our country, many medical institutions to carry out the stem cell clinical trials research projects, the treatment of some refractory diseases has carried on the beneficial exploration; But research condition and their proficiencies of English vary, the researchers to develop stem cell clinical trials research institutions necessary conditions there is no unified standard and decided that, management procedure, to the technology of management and the safety of the participants to bring potential risks. Therefore, screening, clinical trials of stem cell research institutions to establish research base, stem cell clinical trials is stem cell clinical trials stages in the rectification work, study and application specification is also very necessary in a timely manner.

        2, follow the basic principles of is what?

        It is as far as possible with existing laws and regulations, to avoid duplication of effort. Stem cell clinical trials research organization management, mainly to the institutions and personnel engaged in clinical trial research is in line with the clinical drug test specification (GCP) requirements for supervision and management. Stem cell therapy as a new method, although have some different from the existing drugs or characteristics of the traditional technology, but its clinical research and drug clinical trials, must follow the basic principles of GCP. The state food and drug administration has issued the drug clinical trial quality management norms "is China's behavior criterion of drug clinical trials, the same basic principles apply to stem cell clinical trials. At the same time, the state food and drug administration jointly with the ministry of health for medical institutions to carry out the drug clinical trial institution qualification and professional recognition, has been to medical institutions in accordance with the basic requirement of the GCP has carried on the appraisal. , therefore, to have the drug clinical trial institution qualification certificate and have professional qualifications to carry out the corresponding clinical trials of medical institutions as the research base of stem cell clinical trials of precondition, can with the existing drug clinical trial management, also can avoid unnecessary repetition of certification.

        2 it is fully considering the characteristics of the stem cell clinical trials, proper control, steady development. Stem cell therapy and stem cell characteristics of the products is different from ordinary products, its storage, use and common medicines not identical, the mechanism needs further research. Therefore, set the threshold to appropriate stem cell clinical trials research is controlled in the range of a certain number, is conducive to safety and regulatory subjects.

        3, what is the main content of the file?

        Research base of the stem cell clinical trials management approach (trial) "article is divided into six chapters 19 and two attachments, including the general clinical trials, stem cell research base of the task to standard clinical trials, stem cells, stem cell research base in the confirmation process of clinical trials research base of the management, supervision and punishment, and bylaws, accessories including stem cell clinical trials research base of the application materials, application of stem cell clinical trials research base.

        Four, the applied range of this file is what?

        Research base of the stem cell clinical trials management approach (trial) "is suitable for the stem cell clinical trials research base (hereinafter referred to as the base), apply for to maintain, supervision and management of the whole process.

        Look from the applicable objects, the research base of stem cell clinical trials management approach (trial) provisions of the state and provincial health administration and the food and drug regulators, and stem cell clinical trials research base in the main responsibility of the medical institution.

        5, to strengthen the management of base purpose, what is meaning?

        Stem cell clinical trials research is not only the scientific nature, the rationality of the design itself, more need to have appropriate hardware such as people, money, objects, perfect management system, with the support of the ethical, moral and cultural environment, therefore, in order to strengthen the management of base, establish a sound base management rules and regulations is to ensure the safety of stem cell clinical trials, the premise of effectively, is the foundation of the healthy development of stem cell technology.

        What is six, base selection requirement?

        The ministry of health and state food and drug administration (fda) according to the needs of the development of stem cell clinical trials in China, from has been accredited by the state food and drug administration drug clinical trial institutions third rate in hospitals, clinical trials research bases selected stem cells. Stem cell clinical trials research base also should have the ability to independently with stem cell products quality evaluation and in medical, scientific research and teaching with strong comprehensive ability. Clinical trial study, need to have is a senior professional and technical titles, and has a stem cell or cell research work experience.

        Seven, the cognizance of the base program is what?

        According to the needs of the development of stem cell clinical trials, the ministry of health and state food and drug administration organization by stem cell clinical trials research base of the declaration and recognition. Declare unit is to be prepared in accordance with the regulations, stem cell clinical trials research base to fill in application form, submit local provinces, autonomous regions and municipalities directly under the central government health department (bureau) and the food and drug administration (fda) submitted to the ministry of health and state food and drug administration, after preliminary examination by stem cell research and clinical application specification rectification work leading group office (hereinafter referred to as the "office"). Office organization expert committee make a comprehensive review and on-site assessment, and according to the comprehensive evaluation and site assessment results stem cell clinical trials research base on the list.

        What is eight, base management responsibilities?

        Research base of the stem cell clinical trials management approach (trial) "clearly the responsibilities of each related department, base is responsible for the daily management by the medical institutions, provinces, autonomous regions and municipalities directly under the provincial health department (bureau) and the food and drug administration (fda) is responsible for the daily supervision, office is responsible for the organizing committee of experts to carry out regular check of the base and the dynamic appraisal.

        Nine, in violation of regulations and penalties based on what is situation?

        Obtains the qualification of a stem cell clinical trials research base of medical institutions, such as a serious violation of the stem cell clinical trials research base management approach (trial) "relevant provision, illegal conduct stem cell clinical trials, charge to participants, and so on and so forth, withdraw the qualification of stem cell clinical trials research base, at the same time, on the basis of the pharmaceutical administration law," practicing YiShiFa "and the" regulations on the administration of medical institutions "and other relevant laws and regulations, medical institutions, and persons directly responsible liability shall be pursued.

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