With the approval of the National Health and Family Planning Commission, the relevant cord blood collection and supply business can only be carried out after obtaining the Practice License of Blood Station through practice acceptance. It is forbidden to collect blood in one province and one library, and illegal blood collection across regions is strictly prohibited, which is supervised and managed by the provincial health administrative department. Cord blood must be stored in a legal and qualified cord blood bank in order to be protected.
The Ministry of health "umbilical cord blood hematopoietic stem cell bank management approach (Trial)" regulation
Article 2 The umbilical cord blood hematopoietic stem cell bank refers to a special blood bank with considerable research strength, which aims at human hematopoietic stem cell transplantation and has the ability to collect, process, preserve and provide hematopoietic stem cells. ? No unit or individual may collect and supply cord blood for profit.
Twenty-second umbilical cord blood hematopoietic stem cell bank must implement China's "blood station management measures" (provisional) on the management of blood collection and supply. ?
Twenty-third cord blood hematopoietic stem cell bank to collect cord blood hematopoietic stem cells must strictly abide by the technical operating rules and regulations. Personnel involved in the collection, processing and management of umbilical cord blood shall meet the requirements of Technical Specification for Umbilical Cord Blood Hematopoietic Stem Cell Bank. ?
The Technical Specification for Umbilical Cord Blood Hematopoietic Stem Cell Bank shall be formulated separately by the health administrative department of the State Council.
Twenty-fourth units and individuals that have not obtained the practice license of cord blood hematopoietic stem cell bank shall not carry out the collection and supply of cord blood hematopoietic stem cells. ?
Twenty-fifth cord blood collection should follow the principle of voluntary and informed consent. In addition to the informed consent signed by both parties, it should also meet the relevant requirements of medical ethics. ?
Twenty-sixth clinical application units can only accept cord blood provided by cord blood hematopoietic stem cell bank with practice license. ? Umbilical cord blood hematopoietic stem cell bank can only provide umbilical cord blood for hematopoietic stem cell transplantation to clinical units with experience and foundation of hematopoietic stem cell transplantation, equipped with aseptic wards and other necessary facilities for hematopoietic stem cell transplantation, and approved by the provincial health administrative department. ?
Twenty-seventh for humanitarian purposes, to meet the needs of saving lives, to provide overseas medical units with umbilical cord blood for hematopoietic stem cell transplantation, it should be strictly in accordance with the relevant provisions of the "Measures for the Protection and Management of Genetic Resources in China". ?
Twenty-eighth cord blood hematopoietic stem cell bank should ensure the quality of cord blood, the number and activity of hematopoietic stem cells, HLA matching requirements, pathogen detection and so on should be error-free. Without inspection or unqualified inspection, it shall not be provided to medical institutions. ?
Extended data
Relevant regulations on stem cell storage
The National Health Planning Commission and the State Food and Drug Administration jointly issued the Administrative Measures for Stem Cell Clinical Research (Trial), which clearly stipulates that
Institutions engaged in stem cell clinical research must have the qualifications of tertiary hospitals, drug clinical trial institutions and stem cell clinical research and other related conditions and be approved by the State Health Planning Commission. At the same time, no fees related to stem cell clinical research shall be charged to the subjects, and no advertisements for stem cell clinical research shall be published or disguised.
Clinical blood must use qualified blood from legal blood stations.
For clinical use in regular hospitals, qualified blood from legal blood stations must be used. Some "stem cell institutions" are not legal blood banks, and families who store umbilical cord blood in them will face an unacceptable dilemma when they get sick and need to use them in the future.
Umbilical cord blood hematopoietic stem cell bank is a special blood bank approved by the National Health and Family Planning Commission. After obtaining the "Practice License for Blood Station" through practice acceptance, the related umbilical cord blood collection and supply business can be carried out, with one province and one library, and illegal blood collection across regions is strictly prohibited.
According to Article 24 of the Measures for the Administration of Umbilical Cord Blood Hematopoietic Stem Cell Bank (Trial) promulgated by the National Health and Family Planning Commission, any unit or individual that has not obtained the practice license of Umbilical Cord Blood Hematopoietic Stem Cell Bank shall not carry out the collection and supply of Umbilical Cord Blood Hematopoietic Stem Cells. Moreover, the method also stipulates that clinical application units can only accept cord blood hematopoietic stem cells provided by cord blood hematopoietic stem cell bank with practice license.
Reference source? Notice of the Ministry of Health on printing and distributing the measures for the administration of umbilical cord blood hematopoietic stem cell bank (for Trial Implementation)