Recently, the Ministry of Science and Technology released the 15th batch of approval results about the Administrative License for China's Human Genetic Resources Preservation in 2022, and Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Hospital, Wuhan Medical Care Center for Women and Children) has successfully obtained the China human Genetic Resources Preservation License (GKYBSZ No. (2022) BC0081).
In December 2016, our hospital was approved by the Ministry of Science and Technology for China's Human Genetic Resources Preservation for the first time, making it the first legal entity with the qualification of China's Human Genetic Resources Conservation in Hubei Province, and the first medical institution that can obtain the qualification of human genetic resources preservation twice in a row in Hubei Province.
In recent years, the Regulations of the People's Republic of China on the Management of Human Genetic Resources (Decree No. 717) and the Biosafety Law of the People's Republic of China were promulgated successively, which put forward more scientific and rigorous requirements for the protection and application of human genetic resources in China. In strict accordance with the requirements of relevant laws and regulations, our hospital will further strengthen the management of human genetic resources, and encourage and guide the standardized and rational use of human genetic resources. Our hospital has successfully and continuously obtained the qualification for human genetic resources preservation, indicating that the preservation of human genetic resources in our hospital has been recognized by the national science and technology departments and industry experts, and is developing towards a more standardized and scientific direction under the new management requirements.
Our hospital attached great importance to the examination and approval of the preservation. Under the deployment of the hospital leadership, comprehensive preparations have been made from all aspects of the Biobank quality management system in the early stage. In May 2022, our hospital formally submitted the application for approval of continued preservation to the Ministry of Science and Technology. After formal review and data review, president Zhou Aifeng personally led the team to attend the review defense organized by the Ministry of Science and Technology on July 27, and reported the construction of our biobank in detail, including the sample database equipment site, team building, ethical review, quality management system, preliminary work progress, and achievements. The review panel organized by China Human Genetic Resources Management Office of the Ministry of Science and Technology has highly affirmed the construction of biobank in our hospital after hearing the report.
Our hospital now has a Biobank with a design storage capacity of 2 million tubes of samples, which has been provided with -80°C automatic storage system, ultra-low temperature refrigerator, liquid nitrogen tank, gas liquid nitrogen storage tank, automatic blood collection and nucleic acid extraction system, and other specialized sample storage and management information systems. Responsible for the preservation of biological samples from the hospital's birth cohort, twin sub-cohort, beloved cohort and other population cohort projects as well as dozens of specialized disease cohorts, the biobank has stored about 300,000 samples. The quality management system has been established for the Biobank based on the General Requirements for Biobank Quality and Capacity, the International Association of Biological and Environmental Biobank (ISBER) 2018 ISBER Best Practices: Recommendations for Biobank (Fourth Edition) and other relevant standards and guidelines, so as to ensure the quality of samples and their information. The Biobank will regularly carry out internal sample quality control, and participate in the national Biobank laboratory quality assessment and third-party quality control projects. The Biobank will also submit annual preservation report to the Ministry of Science and Technology every year, and receive the examination and supervision of the Ministry of Science and Technology.
Strictly following the national laws and regulations and preservation technology specifications, the Biobank of our hospital will strive to build the high quality samples and databases for women and children's health and disease research, promote the transformation and application of related clinical research outputs, and further promote the high-quality innovation and development of clinical research and translational medicine in our hospital!