Shenzhen legislates the cell and gene industry: bringing the development of the entire cell and gene industry into the scope of promotion!

Another important legislation in Shenzhen’s emerging fields, the “Shenzhen Special Economic Zone Cell and Gene Industry Promotion Regulations (Revised Draft)” was recently submitted to the Standing Committee of the Municipal People’s Congress for review. The regulations include the development of the entire cell and gene industry within the scope of promotion.

The biomedical industry is one of the seven strategic emerging industries in our city, and cells and genes are the most innovative fields with the broadest development prospects. The Standing Committee of the Shenzhen Municipal People’s Congress is the first in the country to enact special legislation to promote the cell and gene industries. This is not only a need to implement new development concepts, but also to meet the needs of the people’s yearning for a healthy life.

This legislationInclude the development of the entire cell and gene industry into the scope of promotion, and make a number of institutional innovations in cell collection and storage, cell and gene product research and development, drug expansion clinical trials, and gene technology applications. Support cooperation between enterprises, scientific research institutions, and medical institutions to carry out clinical trials in the field of cells and genes as well as clinical research initiated by researchers. It is clear that no charges are allowed for clinical research.

One of the highlights of the regulations is to promote the implementation of an expanded clinical trial drug system to meet the needs of patients who are in urgent need of treatment and lack effective medical means for drugs in the clinical trial stage. It is also an outlet for the application of cell and gene products before they are officially launched to meet the needs of both patients and companies.

“Regulations (Revised Draft)” is clear, Cell and gene drugs that are undergoing clinical trials for the treatment of serious life-threatening diseases for which there is no effective treatment. If they may be beneficial after preliminary observation and comply with ethical requirements, they can be used on other patients in the institution conducting clinical trials after review and informed consent. At the same time, it is stipulated that medical institutions must fully inform patients of risks, adverse reactions, relief measures, etc. Subjects have the right to withdraw from the expanded clinical trials in which they participate at any time.

The “Regulations (Revised Draft)” also requires the establishment of a municipal cell and gene science review committee and an ethics review committee. The Scientific Review Committee conducts risk assessment and scientific review, and the Ethical Review Committee is responsible for the ethical review of clinical research and trials, and provides relevant training.

Content source: Shenzhen Special Zone News, Page A03, September 1, 2021

News content has been deleted!