In 2021, the National Health and Health Commission will not accept the application for approval of the setting up of the cord blood bank

Recently, the General Office of the State Health and Health Commission issued a "notice on the approval of the cord hematopoietic stem cell bank", in order to further improve the umbilical cord blood bank management policy, strengthen the umbilical cord blood bank management, optimize the functional layout of the cord blood bank, improve the standard level of practice according to law, ensure medical quality and medical safety, safeguard the people's health rights and interests, after research, decided not to accept the umbilical cord blood bank set up approval applications in 2021.
The cord hematopoietic stem cell bank is a special blood station, and the umbilical cord hematopoietic stem cell bank approved by the National Health and Health Commission is a special blood station with the ability to collect, process, preserve and provide cord hematopoietic stem cells for the purpose of umbilical cord hematopoietic stem cell transplantation.
1998, the Blood Donation Law of the People's Republic of China was promulgated and implemented.
In 1999, the Department of Science and Education of the Former Ministry of Health formulated the Measures for the Administration of cord Hematopoietic Stem Cell Bank (Trial), which defines the Cord Hematopoietic Stem Cell Bank (hereinafter referred to as the Cord Blood Bank) as a special blood station, and implements the planning and management of it, which shall be approved and set up by the administrative department of health under the State Council.
2000, the former Department of Medical Affairs of the Ministry of Health established the umbilical cord blood bank expert committee.
committee of experts on cord blood bank predicts that the establishment of a public library of 8-100,000 copies in China will basically meet the clinical needs, and thinks that the scale of umbilical cord blood bank should not be blindly expanded.
2003-2004, the State Council cleaned up administrative licensing matters, the former Ministry of Health specifically on the umbilical cord blood bank related information reported to the State Council Legal Affairs Office.
In view of the high technical requirements of cord blood storage and the fact that product quality directly relates to the life and health rights and interests of patients, the Legal Affairs Office of the State Council has agreed to retain administrative permits and recommended that the blood station management scope as stipulated in the Blood Donation Law be included.
The Measures for the Administration of Blood Stations were issued in 2006 to manage the cord blood bank as a special blood station, to specify the setting, approval, registration of practice and public welfare nature of the cord blood bank, and to decentralize the supervision of the practice registration of the cord blood bank to the provincial health administrative departments.
Only 7 have been approved so far, and in 2001 the national cord blood bank was established, the Notice on the Planning of the Establishment of the Hematopoietic Stem Cell Bank under the umbilical cord was issued, and 10 within the umbilical cord blood bank (all public libraries) were planned for the national plan for 2001-2005.
2001-2002, according to the umbilical cord blood bank setting plan and the provincial health administrative department declaration materials sequence, has approved the setting up of 10 cord blood bank, respectively, Beijing, Tianjin, Shanghai, Guangdong, Sichuan, Shandong, Zhejiang, Chongqing, Gansu, Liaoning.
7 companies have finally passed the acceptance practice: Beijing, Tianjin, Shanghai, Zhejiang, Shandong, Guangdong and Sichuan.
, Gansu and Liaoning were cancelled for failing to set the required time limit for practice.
in order to strengthen the management of cord blood bank, the ministerial office meeting and expert demonstration meeting were held from 2005 to 2008 respectively to form the opinion that the cord blood bank should be strictly set up for access and strengthen quality management.
2005, the Guidelines for the Planning of the Setting up of Blood Collection Agencies were issued, which provided for the setting up of 10 cord blood banks within the national plan by 2010.
2011, a Notice on Extending the Planning Time for the Umbilical Cord Hematopoietic Stem Cell Bank was issued, extending the umbilical cord blood bank planning until 2015.
2015, a Notice on Extending the Planning Time of the Umbilical Cord Hematopoietic Stem Cell Bank was issued, extending the planning time of the umbilical cord blood bank to 2020, and preparing for the construction of a national cord blood bank.
Supervision and management in order to meet the needs and quality requirements of clinical medical treatment for cord hematopoietic stem cells, issued the "Blood Station Management Measures," "Cord Hematopoietic Stem Cell Bank Management Measures," "Cord Hematopoietic Stem Cell Bank Technical Specifications," "Notice on Strengthening the Management of Cord Hematopoietic Stem Cells" and other regulations and normative documents, strengthen the quality management of cord blood bank, and effectively guarantee the safety of cord hematopoietic stem cells.
held a meeting on the quality management of umbilical cord blood bank in December 2015, inviting the audit bureau to attend the meeting to guide the strengthening of the quality supervision of cord blood bank.
2015, every year to organize experts on the umbilical cord blood bank research or technical verification work, for the problems found, on-site feedback to the local health administrative departments, asked to guide the cord blood bank to do a good job of rectification, to ensure the quality and safety of umbilical cord blood.
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