The National Health Commission of the People’s Republic of China drafted the "Regulations on the Clinical Application of Biomedical New Technologies (Draft for Comment)" (hereinafter referred to as the "Regulations") and solicited opinions from the public on February 26, aiming to standardize clinical research and the application of transformation on biomedical new technologies, promote medical progress, guarantee medical quality and safety, and safeguard human dignity and health.

The "Regulations" defines the "biomedical new technologies". At the same time, the "Regulations" divides low- and high-risk biomedical new technologies and implements hierarchical management and review. Among them, clinical research on high-risk biomedical new technologies includes gene editing technology.

According to the "Regulations", before the clinical research and extensive application of biomedical new technologies such as genetic editing, it may be subject to administrative approval. Clinical research should pass academic review and ethical review, and transformational applications should pass technical assessments and ethical reviews. In addition to the norms, the "Regulations" also emphasize the main body responsibility of the organization, and it is proposed to increase penalties.

Source: biodiscover.com

Time:  2019.03.01