The Health Planning Commission entrusted the genetic sequencing pilot assessment work to the Chinese Medical Association
The highly anticipated " genetic sequencing clinical application" event has a new development. On August 14th, the Chinese Medical Association issued the "Letter on Holding a Second-Generation High-Throughput Gene Sequencing Unit Evaluation Workshop", mentioning that there is no basic condition and relevant norms for clinical application of second-generation sequencing technology, in order to avoid clinical abuse. The National Health and Family Planning Commission entrusted the evaluation of the high-throughput gene sequencing pilot unit to the Chinese Medical Association.
The release of this notice means that genetic testing (especially non-invasive prenatal testing) is a step closer to clinical applications. According to the notification documents of the Food and Drug Administration and the Health Planning Commission, there is currently no non-invasive prenatal testing institution in China. In February 2014, the two ministries clearly stated in the joint “release order†that all medical technologies, including prenatal genetic testing, require the application of testing instruments, diagnostic reagents and related medical software, etc. The regulatory authority approves the registration and is approved by the health and family planning administrative department for technical access. In other words, the clinical application of gene sequencing needs to be approved by the Food and Drug Administration and the Health Planning Commission. The Food and Drug Administration approved the instruments and reagents, and the Health Planning Commission approved the pilot units. The approval of the Health Planning Commission is directly related to whether the reporting unit can enter the medical system and is truly used in the clinic. Prior to the approval of the two sequencing instruments and supporting kits of Huada Gene, they were approved by the Food and Drug Administration and have not yet been approved by the Health Planning Commission. Therefore, the non-invasive prenatal testing of Huada is not currently carried out according to the regulations.
It is also worth noting that the Health Planning Commission entrusted the evaluation of the pilot units to the Chinese Medical Association. Why should we entrust to the Chinese Medical Association? From the brief introduction of the Chinese Medical Association official website, we may see the answer:
"The Chinese Medical Association is an academic, non-profit, non-profit legal person association that is voluntarily composed and legally registered by Chinese medical science and technology workers. It is a bridge and link between the party and the state to contact medical science and technology workers. The important social force for the development of China's medical science and technology industry was established in 1915. There are 83 specialist branches, 500,000 members, 16 departments, 3 legal entities, and medical books jointly organized by the PLA Academy of Military Medical Sciences. 1. The current board of directors of the Chinese Medical Association was established in April 2010. President Chen Hao, Vice President Liu Yanfei, Mamatie·Jinsen, Liu Jun, Liu Depei, Qi Guoming, Wu Mingjiang, Zhang Yanling, Li Lanjuan, Yang Baofeng, Ke Yang, He Fuchu, Zhao Yupei, Hao Xishan, Gu Yudong, Dai Jianping, Wei Yuquan.
The main business of the Chinese Medical Association includes: conducting medical academic exchanges; editing and publishing hundreds of medical and scientific journals and more than 100 kinds of audiovisual publications; conducting continuing medical education; conducting international academic exchanges; and conducting evaluations of medical science and technology projects , judging and medical science and technology decision-making; selecting and rewarding outstanding medical science and technology achievements (including academic papers and popular science works); conducting training and assessment of specialist physicians; discovering, recommending and cultivating outstanding medical science and technology talents; publicizing and rewarding medical ethics, Well-equipped medical personnel; undertake government entrusted functions and undertake commissioning tasks; set up special funds for clinical research to improve clinical research level; organize technical identification of medical accidents and identification of abnormal vaccination technology; promote the transformation and application of medical research results; The party and government reflect the opinions and requirements of medical science and technology workers. â€
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