The legislation refers to the “Regulation on the Promotion of Cell and Gene Industry in the Shenzhen Special Economic Zone” (hereinafter the “Regulation”, 深圳经济特区细胞和基因产业促进条例), which was adopted by the Standing Committee of the Shenzhen People’s Congress on 6 Jan. 2023.
The highlights of the Regulation are as follows.
- The Regulation applies to the research and development, production, operation, application and guarantee of cell and gene products for disease diagnosis and treatment in the Shenzhen Special Economic Zone.
- Before collecting cells, enterprises, scientific research institutions, medical and health institutions and entrusted institutions shall clearly inform the subject of the collection purpose, collection use, possible impact on health, personal privacy protection measures, rights and obligations of the subject, and obtain the written consent of the subject.
- Enterprises, universities, scientific research institutions, and medical institutions are supported to cooperate in clinical research and trials in the field of cells and genes.
- For cell and gene drugs undergoing clinical trials to treat severe life-threatening diseases for which there is no effective treatment after medical analysis finds that the benefits may outweigh the risks and meet ethical requirements, they shall be reviewed per national regulations and obtain informed consent. After that, the drugs shall be used in other patients with the same condition and unable to participate in drug clinical trials through extended trials within the medical institutions conducting clinical trials.
- Enterprises and scientific research institutions are supported to carry out research on gene sequencing technology and biological information analysis technology and develop gene sequencing tools with core intellectual property rights, as well as supporting equipment, software and databases.
Photo by Bosi Zhang on Unsplash
Contributors: CJO Staff Contributors Team
