Shenzhen Introduces the Nation’s First Special Legislation on the Cell and Gene Industry
Release Date:
2023-03-02 17:00
Reprinted from the Shenzhen People’s Congress website. If there is any infringement, please contact us for removal.
On January 6, 2023, the Standing Committee of the Shenzhen Municipal People’s Congress announced that the nation’s first specialized legislation on the cell and gene industry—the Regulations of the Shenzhen Special Economic Zone on Promoting the Cell and Gene Industry (hereinafter referred to as the “Regulations”)—has been adopted by vote and will come into effect on March 1.
This means that the system for expanded-access clinical trials of cell and gene therapies has been implemented in Shenzhen, allowing cell and gene therapies currently undergoing clinical trials for the treatment of life-threatening conditions with no effective existing treatments to be used within medical institutions for other patients with the same condition who are unable to participate in such clinical trials.
The Regulations stipulate that, for cell and gene therapies currently undergoing clinical trials for the treatment of life-threatening diseases for which no effective therapeutic options yet exist, if medical analysis indicates that the potential benefits outweigh the risks, the therapy meets ethical requirements, has been reviewed in accordance with national regulations, and informed consent has been obtained, such therapies may, within the medical institutions conducting the clinical trials, be used on an expanded-access basis for other patients with the same condition who are unable to participate in the clinical trial.
The Regulations also explicitly stipulate that, for the conduct of expanded-access clinical trials of cell and gene therapies, the corresponding clinical trial phase supporting the marketing authorization application must have already been completed; the drug registration applicant must have submitted a marketing authorization application to the National Medical Products Administration; and the applicant must have applied for and obtained approval to conduct the expanded-access clinical trial in accordance with national regulations. On the basis of existing data demonstrating the safety and efficacy of cell and gene therapies, this approach further enhances the accessibility of these medicines.
Full text published:
Regulations of the Shenzhen Special Economic Zone on Promoting the Cell and Gene Industry
(Adopted at the 14th Session of the Standing Committee of the 7th Shenzhen Municipal People’s Congress on December 29, 2022)
Table of Contents
Chapter 1 General Provisions
Chapter 2: Collection and Storage of Cells
Chapter 3: Research and Development of Cell and Gene Products
Chapter 4: Expanded Access Clinical Trials for Drugs
Chapter 5: Applications of Genetic Technology
Chapter 6: Marketing Authorization and Product Manufacturing
Chapter 7: Safeguard Measures
Chapter 8 Legal Liability
Chapter IX Supplementary Provisions
Chapter 1 General Provisions
Article 1 In order to promote the healthy, sustainable, and high-quality development of the cell and gene industry, explore industrial development models and regulatory approaches, enhance the overall development level of the biopharmaceutical industry, and better meet the public’s demand for a healthy lifestyle, these Regulations are formulated in accordance with the basic principles of relevant laws and administrative regulations and in light of the actual conditions of the Shenzhen Special Economic Zone.
Article 2 This Regulation shall apply to activities related to the research, development, production, operation, use, and safeguarding of cell and gene products for disease diagnosis and treatment conducted within the Shenzhen Special Economic Zone.
Foreign investors and foreign-invested enterprises investing in the cell and gene industry shall comply with the State’s relevant regulations on foreign investment access.
Article 3 The development of the cell and gene industry shall adhere to the following principles:
(1) Research and development shall adhere to scientific standards and ethical principles;
(2) Production shall adhere to risk management and end-to-end control;
(3) Applications shall adhere to a health-oriented approach and deliver benefits to the public;
(4) Ensure the commitment to optimizing services and promoting development.
Article 4 The Municipal People’s Government shall be responsible for overall coordination of the city’s cell and gene industry development, formulating policies and measures to promote such development, and coordinating major matters arising in the course of industry development.
The District People’s Government is responsible for overall coordination of the development of the cell and gene industry within its jurisdiction.
Article 5 The municipal departments of development and reform, science and technology innovation, industry and information technology, health, and market regulation shall, within the scope of their respective functions and responsibilities, formulate and implement policies and measures to promote the development of the cell and gene industries.
The municipal science and technology innovation authority, the municipal health authority, and the municipal market regulation authority shall, within their respective jurisdictions, carry out cell and gene-related supervision and management in accordance with the law.
Article 6 The Municipal People’s Government shall incorporate the development of the cell and gene industry into the biopharmaceutical industry development plan.
Conducting statistical analysis and development evaluation of the biopharmaceutical industry requires disaggregating data on the development of the cell and gene therapy sectors, while strengthening information disclosure and policy guidance.
Article 7 The Municipal People’s Government shall strengthen the management and protection of human genetic resources, effectively prevent and respond to biosafety risks, and promote the stable and healthy development of the cell and gene industries.
Matters related to biosafety in the research, development, production, and application of cell and gene products shall be governed by the relevant laws and administrative regulations of the State.
Article 8: The municipal health and wellness authorities, market regulatory authorities, and other relevant departments shall adopt appropriate regulatory measures based on the risk level of cell and gene products.
Enterprises, research institutions, and medical and health care institutions shall establish a comprehensive risk control system for cell and gene products and implement necessary risk management and control measures.
Article 9 The Municipal People’s Government shall improve the clinical research and clinical trial system, establish a mechanism for coordinated development between clinical medicine and the cell and gene industries, and provide support for the development of the cell and gene industries.
Article 10: Activities related to research, development, and application in the fields of cell and gene technologies shall not jeopardize public health, national security, or the public interest, and shall be subject to ethical review in accordance with relevant national regulations.
Article 11: Fully leverage the role of industry organizations related to cells and genes in areas such as research collaboration, policy recommendations, international exchanges, standard-setting, and self-regulation.
Article 12 The Municipal People’s Government shall promote international and domestic cooperation in the cell and gene industry, support enterprises, institutions of higher learning, research institutes, and medical and health institutions in participating in the research and formulation of relevant rules and regulations, conduct scientific and technological exchanges, and foster innovation and development in the industry.
Chapter 2: Collection and Storage of Cells
Article 13: The collection of blood and tissue samples obtained by means of injurious or invasive procedures for the purpose of cell acquisition shall be conducted by medical and health institutions that possess the requisite qualifications and conditions. If enterprises or research institutions need to collect cells using the aforementioned methods, they shall entrust such collection to medical and health institutions.
Article 14: Medical and health institutions shall collect cells in accordance with medical technical standards and conduct such collection activities only within the scope of their practice registration.
Medical and health institutions shall establish a quality management system and standard operating procedures, ensure adequate staffing, facilities, infrastructure, equipment, and instruments commensurate with their collection capabilities, and develop emergency response plans.
Article 15: Before collecting cells, enterprises, research institutions, medical and health institutions, and entrusted agencies shall clearly inform the donor of the purpose of the collection, the intended uses of the collected cells, any potential health impacts, measures for protecting personal privacy, and the donor’s rights and obligations, and shall obtain the donor’s written consent.
Where the person whose data is being collected is a minor, a person with no civil capacity, or a person with limited civil capacity, written consent from the guardian must also be obtained.
Article 16: Enterprises, research institutions, and medical and health institutions that store collected cells and the data generated therefrom shall manage such materials in accordance with relevant regulations.
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