Another important Shenzhen legislation in an emerging field — the Shenzhen Special Economic Zone Regulations on Promoting the Cell and Gene Industry (First Revised Draft) — was recently submitted to the Standing Committee of the Municipal People's Congress for review. The Regulations bring the entire cell and gene industrial chain into the scope of promotion.
The biopharmaceutical industry is one of Shenzhen's seven strategic emerging industries, and cells and genes are the most innovative areas with the broadest development prospects within it. The Standing Committee of the Shenzhen Municipal People's Congress has taken the lead nationwide in dedicated legislation to promote the cell and gene industry. This is needed not only to implement the new development philosophy, but also to meet the people's aspirations for a healthier life.
This legislation brings the development of the entire cell and gene industrial chain into the scope of promotion, and creates a series of institutional innovations in cell collection and storage, R&D of cell and gene products, expanded clinical trials of drugs, and applications of gene technologies. It supports cooperation among enterprises, scientific research institutions, and medical institutions in conducting clinical trials and investigator-initiated clinical research in the cell and gene field, and clarifies that no fees may be charged for clinical research.
A major highlight of the Regulations is the implementation of the system for expanded clinical trial use of investigational drugs, in order to meet the needs of patients in urgent need of treatment who lack effective therapies for drugs at the clinical trial stage, and at the same time to provide an outlet for the application of cell and gene products before formal market launch — meeting the needs of both patients and enterprises.
The Regulations (First Revised Draft) make clear that cell and gene drugs undergoing clinical trials for the treatment of diseases that are seriously life-threatening and lack effective treatments may, if preliminary observations indicate possible benefit and ethical requirements are met, be used for other patients within the institution conducting the clinical trial, after review and informed consent. The draft also requires that medical institutions fully inform patients of risks, adverse reactions, and remedy measures. Subjects have the right to withdraw at any time from the expanded clinical trial in which they are participating.
The Regulations (First Revised Draft) also require the establishment of a Municipal Cell and Gene Scientific Review Committee and an Ethics Review Committee. The Scientific Review Committee will conduct risk assessment and scientific review, while the Ethics Review Committee will be responsible for ethical review of clinical research and trials and conduct related training.
Source: Shenzhen Special Zone Daily, September 1, 2021, Page A03 (Top News)
