Legislation to encourage cell technology research and development! “Shenzhen Special Economic Zone Cell and Gene Industry Promotion Regulations (Draft for Comments)” was officially released

November 12, 2021 Shenzhen’s important legislation in emerging fields, the “Shenzhen Special Economic Zone Cell and Gene Industry Promotion Regulations (Draft for Comments)”, is publicly soliciting opinions on the website of the Shenzhen Municipal People’s Congress Standing Committee.

In order to implement the “Comprehensive Reform Pilot Implementation Plan for Shenzhen’s Construction of a Pioneer Demonstration Zone of Socialism with Chinese Characteristics (2020-2025)”, promote the healthy, sustainable and high-quality development of the cell and gene industry, enhance the overall development level of the biopharmaceutical industry, and better meet the people’s needs for a healthy life, in accordance with the annual legislative plan arrangement of the Municipal People’s Congress Standing Committee, the “Shenzhen Special Economic Zone Cell and Gene Industry Promotion Regulations (Draft for Comment)” is publicly solicited on the website of the Shenzhen Municipal People’s Congress Standing Committee.

“Regulations (Draft for Comments)”Standardizes cell collection and storage behavior, specifies the expanded clinical trial system for cell and gene drugs, and encourages the research and development and use of cell and gene technologies.

 

Article 17  Encourage enterprises, scientific research institutions, and medical and health institutions to establish scientific research institutions related to the cell and gene industries in this city.

Encourage enterprises, scientific research institutions, and medical and health institutions to conduct industry-university-research cooperation, share industrial resources, support basic research in the fields of major cell and gene theories, original technologies, cutting-edge interdisciplinary subjects, and promote original innovation in science and technology.

Article 18  The Municipal People’s Government should integrate superior forces and resources, build a public service system that complies with quality management standards, and support the research and development of cell and gene products.

Article 19  Support enterprises, scientific research institutions, and medical and health institutions to cooperate in clinical trials in the field of cells and genes, as well as clinical studies initiated by researchers.

Article 20  The Municipal People’s Government should increase financial investment in clinical research in the field of cells and genes, strengthen the training of clinical research talents, establish clinical research funding projects, build a public service platform for clinical research support, and establish and improve an institutional system to support the development of clinical research.

Article 21   When conducting clinical research and clinical trials in the field of cells and genes, the dignity of subjects shall be maintained, and the subjects’ rights to life and health, informed consent, privacy, withdrawal, and access to medical treatment and financial compensation shall be protected.

Article 22 

Article 23 Encourage the effective accumulation of real-world data in clinical research in the field of cells and genes, improve the applicability of real-world data, and provide evidence of safety and effectiveness for the registration of new drugs, or provide evidence for changes in the instructions of already marketed drugs.

Article 24  The municipal health department shall, in conjunction with the municipal market supervision department, strengthen the supervision, management and guidance of medical and health institutions in standardizing clinical research and clinical trials in the field of cells and genes.

 

News source: Shenzhen Municipal People’s Congress Standing Committee Website

View the original text of the “Regulations (Draft for Comments)”: http://www.szrd.gov.cn/rdyw/fgcayjzj/content/post_742653.html