Potential New Regulation on Clinical Application of New Biomedical Technologies

China
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The National Health Commission ("NHC") of the People's Republic of China ("PRC") released the Administrative Regulations for the Clinical Application of New Biomedical Technologies (Draft for comments) ("Draft") on 26 February 2019. According to the Draft, New Biomedical Technology ("NBT") refers to molecular and cellular approaches and measures that have completed the pre-clinical research in order to diagnose diseases, prevent diseases, cure diseases, relieve pain, extend life or restore health. The clinical research of NBTs refers to the human testing before the application of the NBTs in order to observe and judge the safety, efficacy, scope of application of the NBT, or to clarify the operation proceedings and precautions. Human testing includes but is not limited to:

  1. Testing on the human body directly;
  2. Trials on tissues, organs or cells and then implanting those tissues, organs or cells in the human body; and
  3. Trials on the human germ cells, zygotes or embryos, and then implanting the germ cells, zygotes or embryos in human body.

Clinical Research of NBTs cannot be carried out unless the government have approved it. NBTs classed as high risk are now subject to the management of the NHC. High risk NBTs include:

  • Those involving any changes to genetic materials or the regulation of gene expression, for example, gene transfer technologies, gene editing technologies, gene modulation technologies, stem cell technologies, somatic cell technologies and mitochondrial replacement technologies;
  • Those involving xeno-cells, xeno-tissues or xeno-organs, for example, using xeno-biomaterials, or using xeno-cells, xeno-tissues or xeno-organs as growth-medium via cloning technology;
  • Those generating new species of creatures, or biological products that apply to the human body, for example, synthetic creatures and microbiota transplantation technologies with gene modification;
  • Those involving assisted reproductive technologies; and
  • Other research projects facing high technological risks, great difficulty and other potential influences.

Any clinical research of NBTs must pass academic review and ethical review. The application of the NBTs is subject to additional technology evaluation and ethical review. The NBT cannot enter the clinical trial stage if it has not been proven to be safe or efficacious by the clinical research.

The medical institution is responsible for the clinical research of the NBT. The person in charge of the medical institution is the primary responsible person. The medical institution should ensure that:

  • The benefits of the research outweigh the risks to the human subjects;
  • The human subjects have fully understood all the information of the NBT clinical trial and have voluntarily consented to it;
  • The human subjects can end the participation at any time without giving any reasons and their dropout will not cause any discrimination to them; and
  • The human subjects are protected by confidentiality measures.

In addition, the Draft also provides for the supervision and legal liability in relation to the clinical research, clinical trial and application of the NBT.

To read the full text of the Draft (in Chinese only), please click on 'Download publication' button.