NHC Seeks Comments on Administrative Regulations for the Clinical Application of New Biomedical Technologies

The National Health Commission ("NHC") has recently enacted and issued the Administrative Regulations for the Clinical Application of New Biomedical Technologies (Draft for Comment) (the "Draft for Comment") to seek public comments by March 27, 2019.

The Draft for Comment, comprising 63 articles in seven chapters, is mainly aimed at: 1. specifying the scale of the administration; 2. introducing the administrative approval regime to the clinical research, transformation and application of new biomedical technologies; 3. providing for what an academic review and an ethical review should involve respectively; 4. stressing the subject responsibilities of medical institutions; 5. imposing severer punishment against violations; and 6. coordinating with the administration of drugs and medical devices. Among others, the Draft for Comment states that, an institution that intends to carry out clinical activities shall fulfill certain requirements, including "becoming a Grade 3 first-class hospital or a Grade 3 first-class maternal and child care service center". Furthermore, the Draft for Comment emphasizes that medical institutions should be the subjects held responsible for clinical studies of new biomedical technologies, and their principals should be the primary responsible persons.



(Source: http://www.nhc.gov.cn/yzygj/s7659/201902/0f24ddc242c24212abc42aa8b539584d.shtml)

Note: The link to the Chinese official website of the document is for your reference.