China's ministry of health has issued regulations related to the clinical application of stem cell t
On March 2, 2009, the ministry of health promulgated the "management measures for clinical application of medical technology", which divides medical technology into three types of management. The second type of medical technology is the medical technology that is safe and effective, involves certain ethical problems or has high risks, and should be controlled and managed by the health administrative department. Third class medical technology has a high risk, involving major ethical issues, security, effectiveness is still need to the specification of clinical trials research further validation, you need to use the scarce resources, you would like the health administrative departments to strictly control the management of medical technology, and the ministry of health, who is directly responsible for the clinical application of the third class medical technology management work.
Management approach to treatment of autologous stem cells and immune cells, allogeneic stem cell transplantation into the third class medical technology management (refers to the allogeneic stem cell transplantation of autologous stem cell transplantation) provided by the others, and heterogeneous temporary shall not be applied to clinical stem cell transplantation (that is, the one source of stem cells other than other animals shall not be applied to clinical). At the same time, the request has been carried out stem cells as the three categories of clinical application of medical institutions of medical treatment, continuing application must be made and measures for the administration of 6 months after the formal implementation to the ministry of health designated third class medical technology clinical application ability to audit organization to apply for review, through capacity after the audit report for examination and approval of the ministry of health, as of October 31 did not apply for technical audit or not through the audit institution shall cease to clinical application.
The measures for the management regulation of medical institutions also obtained within 2 years after the third class medical technology access permission, shall be reported to the ministry of health of clinical application of a year, including clinical cases, indications, and clinical application effects, complications, complications and adverse reactions, the follow-up situation, when necessary, the ministry of health to organize experts on-site verification.
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