Chapter IGeneral Provisions
Article 1 To promote the healthy, sustainable and high-quality development of the cell and gene industry, explore industrial development patterns and regulation methods, improve the overall development of the biomedical industry, and better meet people’s pursuits for a healthy life, these Regulations are formulated in accordance with the foundational principles specified in relevant laws and administrative regulations and in light of the specific circumstances in Shenzhen Special Economic Zone.
Article 2 These Regulations shall apply to the research, development, production, marketing, use and guarantee of cell- and gene-based products used for disease diagnosis or treatment within Shenzhen Special Economic Zone.
Any foreign investor or foreign-invested enterprise that intends to invest in the cell and gene industry shall abide by national regulations on foreign investment access.
Article 3 The cell and gene industry shall develop according to the following principles:
(1) Conducting research and development in a scientific, standardized and ethical way;
(2) Conducting risk management and whole-process control during production;
(3) Pursuing the health and benefits of people during the application;
(4) Optimizing services and promoting development.
Article 4 Shenzhen Municipal People’s Government shall advance the holistic administration of the cell and gene industry in this municipality, formulate policies and measures to promote industrial development, and address major issues in industrial development in a coordinated manner.
District people’s governments shall advance the development of the cell and gene industry within its jurisdiction holistically.
Article 5 The municipal authorities of development and reform, science, technology and innovation, industry and information technology, public hygiene and health, and market regulation shall formulate and implement relevant policies to promote the development of the cell and gene industry within their respective duties.
The municipal authorities of science, technology and innovation, public hygiene and health, and market regulation shall supervise and administer the cell and gene industry according to the law within their respective duties.
Article 6 Shenzhen Municipal People’s Government shall incorporate the development of the cell and gene industry into the development plan of the biomedical industry.
Statistical analysis and development evaluation shall be conducted on the biomedical industry by elaborating on the development of the cell and gene industry and increasing the disclosure of industrial information and policy guidance.
Article 7 Shenzhen Municipal People’s Government shall strengthen the management and protection of human genetic resources, reduce biosecurity risks, prevent crises, and promote the stable and healthy development of the cell and gene industry.
Matters related to biosecurity in the research, development, production and application of cell- and gene-based products shall be subject to relevant laws and administrative regulations of the state.
Article 8 The municipal public hygiene and health authority and the municipal market regulation authority shall take appropriate administrative measures based on the risk level of cell- and gene-based products.
Enterprises, scientific research institutions and medical and healthcare institutions shall establish a sound risk control system for cell- and gene-based products and take necessary risk control measures.
Article 9 Shenzhen Municipal People’s Government shall improve the clinical research and trial system, establish a coordinated development mechanism between clinical care and the cell and gene industry, and support the development of the cell and gene industry.
Article 10 Whoever engages in the research, development or application of cells and genes shall not endanger public health, national security or public interests, and shall be subject to the ethical review in accordance with relevant national regulations.
Article 11 It is encouraged that cell- and gene-related industry organizations fully engage in research cooperation, policy recommendations, international exchanges, standard formulation and self-discipline management.
Article 12 Shenzhen Municipal People’s Government shall promote international and domestic cooperation in the cell and gene industry, and encourage enterprises, higher learning institutions, scientific research institutions and medical and healthcare institutions to participate in the study and formulation of relevant rules, engage in scientific and technological communication in the industry, and boost industrial innovation and development.
Chapter IICell Collection and Storage
Article 13 The collection of a blood or tissue sample by damaging or invasive means shall be conducted by a medical and healthcare institution with corresponding qualification and capacity. If an enterprise or scientific research institution needs to collect cells by the above means, it shall entrust a medical and healthcare institution to do the collection.
Article 14 Medical and healthcare institutions shall collect cells according to medical technical specifications and within the scope of registration for practice.
Medical and healthcare institutions shall establish quality management systems and standard operating procedures, be equipped with personnel, venues, facilities, equipment and instruments commensurate with their collection capabilities, and formulate emergency response measures.
Article 15 Before collecting cells, the enterprise, scientific research institution, medical and healthcare institution or the entrusted institution shall clearly inform the person whose cells will be collected of the purpose of collection, use of collected cells, possible impact on his health, protection measures on his privacy, and his rights and obligations, and shall obtain his written consent.
If the person whose cells will be collected is a minor or has no or limited civil capacity, written consent from his guardian is also required.
Article 16 Any enterprise, scientific research institution or medical or healthcare institution that needs to store cells and resulting data shall follow relevant regulations.
Measures for the administration of cell collection and storage shall be separately formulated by the municipal public hygiene and health authority jointly with the municipal market regulation authority.
Article 17 It is encouraged that cell banks open to enterprises, higher learning institutions, scientific research institutions and medical and healthcare institutions in accordance with the law, so as to promote the sharing of industrial resources and data.
Chapter III Research and Development of Cell- and Gene-based Products
Article 18 It is encouraged that enterprises, higher learning institutions, scientific research institutions and medical and healthcare institutions set up scientific research institutions related to the cell and gene industry in this municipality.
It is encouraged to promote industry-university-research cooperation among enterprises, higher learning institutions, scientific research institutions and medical and healthcare institutions, share industrial resources, carry out basic research on major cell and gene theories, original technologies and cutting-edge interdisciplinary disciplines, and bring about original innovation in science and technology.
Article 19 Shenzhen Municipal People’s Government shall build a public service system that meets quality management norms by using advantageous resources, and support the research and development of cell- and gene-based products.
Article 20 It is encouraged that enterprises, higher learning institutions, scientific research institutions and medical and healthcare institutions work together in clinical research and trials on cells and genes.
Clinical research as mentioned in these Regulations refers to the activity carried out by a medical and healthcare institution to study the diagnosis, treatment, rehabilitation, prognosis, etiology, prevention or health maintenance, targeting at a natural person or group (including medical information), but not aiming to register any medicine or medical device (including in-vitro diagnostic reagent).
Clinical trial as mentioned in these Regulations refers to the test carried out in a qualified medical and healthcare institution to determine the safety and effectiveness of a medicine or medical device (including in-vitro diagnostic reagent) and aiming to register a product in accordance with relevant national clinical trial management norms.
Article 21 Shenzhen Municipal People’s Government shall increase financial investment in the clinical research on cells and genes, strengthen the cultivation of clinical research professionals, set up clinical research funding projects, build a public service platform to support clinical research, and establish a sound system to support the development of clinical research.
Article 22 In the clinical research and trial on cells and genes, the dignity of the person accepting the clinical research or trial, and his rights and interests, such as the rights to life, health, know, consent, privacy, withdraw and access medical treatment and economic compensation shall be safeguarded.
Article 23 The medicine for the clinical research or trial on cells or genes shall be produced according to the quality control standards for medicine production.
Article 24 It is encouraged to collect practical data during the clinical research on cells and genes, so as to enhance the applicability of practical data, prove the safety and effectiveness of new medicines during registration, or justify the alteration to the instruction of the medicine on sale.
Article 25 The municipal public hygiene and health authority shall, together with the municipal market regulation authority, supervise, administer and guide medical and healthcare institutions in standardized clinical research and trials on cells and genes with more efforts.
Article 26 The municipal public hygiene and health authority shall, together with relevant authorities, formulate relevant policies to encourage tertiary medical and healthcare institutions to conduct clinical research or trials on cells and genes, and to set up internal clinical research management institutions and research-based wards.
If a hospital bed of a medical and healthcare institution is used for clinical research or trial, after being confirmed by the municipal public hygiene and health authority, it may be exempted as a factor from the target assessment of average days in hospital, turnover number, utilization rate and related treatment cost of the medical and healthcare institution.
Article 27 Medical staff such as physicians and pharmacists shall be encouraged to engage in clinical research or trials on cells and genes. Relevant outcomes can be referred to as an effective achievement in professional and technical qualification evaluation or recruitment.
Article 28 It is encouraged that insurance companies develop insurance products for the cell and gene industry, such as clinical research and clinical trial liability insurance, product liability insurance and commercial health insurance.
For high-risk clinical research and trial on cells and genes, it is encouraged to buy commercial insurance to cover the treatment costs and corresponding financial compensation if the person accepting the clinical research or trial suffers health damage or dies due to the project.
Chapter IVExtended Clinical Trials of Medicines
Article 29 The cell- or gene-based medicine that is undergoing a clinical trial for the treatment of a serious life-threatening disease where no effective treatment is available can be used on a patient who has the same disease but is unable to participate in the trial by means of extended clinical trial and in the medical and healthcare institution which carries out the clinical trial, only if the following requirements are satisfied:
(1) The medicine’s benefits may outweigh its risks, which is the conclusion of medicine analysis;
(2) Ethical requirements are satisfied;
(3) The medicine has passed the review procedures stipulated by national regulations;
(4) The patient is informed of all necessary information and gives his consent.
The extended clinical trial on a cell- or gene-based medicine may not be conducted until the following requirements are satisfied:
(1) The clinical trial stage to support the marketing registration of the new medicine has been completed;
(2) The medicine registration applicant has applied for marketing permission from National Medical Products Administration and has applied to conduct extended clinical trials in accordance with relevant national regulations and obtained approval.
Article 30 If an applicant for the registration of a cell- or gene-based medicine needs to communicate with the medicine evaluation center of National Medical Products Administration on relevant issues before or during the application for the extended clinical trial on a cell- or gene-based medicine, the municipal market regulation authority shall provide necessary counseling and services.
Article 31 The applicant for the registration of a cell- or gene-based medicine shall be encouraged to provide a cell- or gene-based medicine used in the extended clinical trial for a patient with a serious life-threatening disease for which no effective treatment is available, provided that the patient is voluntarily and his interests are guaranteed. Safety data of the cell- or gene-based medicine used in the extended clinical trial can be referred to in the marketing permission application.
Article 32 Before the extended clinical trial on a cell- or gene-based medicine, the medical and healthcare institution and the clinical trial applicant shall disclose to the patient necessary matters that may affect his decision, including possible effects, risks, adverse reactions and remedy measures of the cell- or gene-based medicine, and give him special tips on the risks and consequences. The patient shall sign the informed consent letter on the basis of understanding the above matters.
If the patient is a minor, or has no or limited civil capacity, the medical and healthcare institution or the clinical trial applicant shall disclose the matters specified in the preceding paragraph to his guardian, who shall sign the informed consent letter.
Article 33 The person accepting the clinical research or trial shall have the right to withdraw unconditionally from the extended clinical trial on the cell- or gene-based medicine at any time. The medical and healthcare institution and the clinical trial applicant shall inform the person of possible risks, adverse reactions and remedy measures after withdrawal.
Article 34 In any of the following circumstances, the extended clinical trial on the cell- or gene-based medicine shall be terminated:
(1) A serious and unexpected adverse reaction happens during the clinical use of the cell- or gene-based medicine;
(2) The cell- or gene-based medicine has a quality issue;
(3) Data from the further clinical trial on the cell- or gene-based medicine can not prove its effectiveness;
(4) The cell- or gene-based medicine has been approved to be on sale by National Medical Products Administration.
(5) Other circumstances where the extended clinical trial shall not be conducted.
Chapter V Application of Gene Technology
Article 35 It is encouraged to support enterprises and scientific research institutions in engaging in the research on gene sequencing technology and bioinformation analysis technology, and developing gene sequencing tools, supporting equipment, software and databases with core intellectual property rights.
It is encouraged that enterprises and scientific research institutions join the formulation of international, national, industry and group standards related to gene sequencing and bioinformation analysis.
Article 36 Sample collection institutions and gene testing institutions shall take necessary measures such as de-identification in the process of sample circulation and test information transmission to protect the privacy of those who accept the clinical research or trial and ensure the security of gene information.
Article 37 Gene sequencing information shall be used with the consent of those who accept the clinical research or trials. If written consent is required by laws or administrative regulations, such provisions shall apply.
Article 38 If gene sequencing results are used to make judgments on disease risk, medication plan, nutrition, metabolism or reproductive risks, the judgment shall be made on a reasonable basis and the source of the basis shall be explained.
Article 39 It is encouraged that medical and healthcare institutions apply genetic diagnostic technology in auxiliary clinical diagnosis.
Chapter VI Marketing Permission and Production
Article 40 The municipal market regulation authority shall provide preliminary services such as policy consulting and whole-process business counseling for the enterprise that applies for marketing permission of an innovative cell- or gene-based medicine and medical device.
Article 41 For a product that falls in the scope of breakthrough therapy, conditional marketing permission, and priority or special review and approval procedures, the municipal market regulation authority shall establish convenient and smooth consulting channels to help enterprises communicate with National Medical Products Administration and Guangdong Medical Products Administration on registration, review and licensing, follow up the registration progress timely, and provide counseling for enterprises to apply for listing registration with National Medical Products Administration.
Article 42 The municipal market regulation authority may propose a list of recommended key projects, key enterprises and key regions to Guangdong Medical Products Administration in accordance with the provisions on innovative services for the biomedical industry. The municipal market regulation authority shall also encourage the applicant for the registration of a cell- and gene-based medicine and medical device to apply to Guangdong Medical Products Administration for establishing a key project and key enterprise in the biomedicine industry.
The municipal market regulation authority shall offer convenience to the applicant for the registration of the cell- and gene-based medicine or medical device that is used in a key project, by a key enterprise or in a key region, so as to accelerate the progress of marketing.
Article 43 The enterprise shall, in accordance with the system for holders of medicine marketing permission or registrants and file holders of medical devices, produce the cell- or gene-based product by itself or entrust another qualified enterprise.
If production is entrusted, the entrusting and the entrusted shall sign an entrustment agreement and a quality agreement to ensure product quality and safety.
The enterprise shall establish relevant well-functioning management systems and take effective risk control measures in accordance with relevant national and provincial regulations concerning direct reporting of adverse reactions by medicine marketing permission holders or monitoring of adverse events by medical device registrants and record holders.
Article 44 The cell- and gene-based product shall be produced according to production quality management norms for medicines and medical devices as well as relevant appendices.
The manufacturer of the cell- and gene-based product shall establish a risk assessment system, develop risk control strategies, and eliminate the risks that affect the quality of the cell- and gene-based product.
Article 45 The manufacturer of the cell- and gene-based product shall establish a quality control system that covers the whole process, including collection, transportation, reception, production, inspection and the release, storage and transportation of the finished product.
Article 46 The manufacturer of the cell- and gene-based product shall establish an information management system and an electronic tracking system to record, track, evaluate and manage product quality in all aspects to ensure true, accurate, complete and traceable information in the whole process.
Article 47 It is encouraged that Shenzhen Institute for Drug Control inspects and tests the quality of cell- and gene-based products as entrusted by national drug testing institutions, organizes the formulation of local standards and group standards for cell- and gene-based products, and conducts technical arbitration. It is also encouraged that it applies for the qualification as a national batch inspection institution for biological products.
It is encouraged to establish or introduce qualified third-party professional inspection and testing institutions to inspect and test the quality of cell- and gene-based products.
Article 48 A municipal inspection and testing platform for cell- and gene-based products led by Shenzhen Institute for Drug Control and supported by other qualified third-party professional inspection and testing institutions shall be established to carry out research on inspection and testing methods, quality standards and safety evaluation technologies, so as to improve inspection and testing services for cell- and gene-based products.
Article 49 The enterprise, scientific research institution and medical and healthcare institution shall promote or interpret the cell- and gene-based product objectively, truthfully and accurately. False or misleading publicity shall be prohibited.
Chapter VIISupporting Measures
Article 50 Shenzhen Municipal People’s Government shall promulgate relevant measures to support the development of the cell and gene industry by consolidating the industrial foundation, upgrading the industrial and supply chains, ensuring sufficient industrial support, building professional teams, supporting scientific research, and offering financial support.
Article 51 Shenzhen Municipal People’s Government shall incorporate the development of the cell and gene industry into the coordination mechanism for the development of the biomedical industry.
Article 52 The municipal authorities of development and reform, industry and information technology, public hygiene and health, and market regulation shall enhance the efficiency of administrative review of matters related to the cell and gene industry within their respective duties.
Article 53 It is encouraged to establish sub-centers of National Medical Products Administration for the evaluation and inspection of medicines and medical devices in Guangdong-Hong Kong-Macao Greater Bay Area, so as to promote the development of the cell and gene industry in Shenzhen.
Article 54 The municipal authorities of science, technology and innovation, public hygiene and health, and market regulation shall provide consulting and guidance for enterprises, scientific research institutions and medical and healthcare institutions to apply for the review of human genetic resources. A human genetic resources review management platform shall be established to improve human genetic resources review, and support the research and development of new medical products and technologies for cell and gene therapies.
Article 55 Shenzhen Municipal People’s Government shall promote cooperation in the cell and gene industry, guide third-party enterprises to provide services such as pharmaceutical research, preclinical research, clinical research, clinical trials, standard formulation, inspection, testing, registration and application, build up an industry incubation system in the whole process and improve industrial services in the whole process.
Article 56 It is encouraged that enterprises try to break through in key reagents, consumables, instruments or devices that are necessary for the cell and gene industry chain to realize automatic and controllable industry and supply chains.
Article 57 It is encouraged to promote the research and development of the cell and gene industry, and the development of production outsourcing platforms.
The municipal development and reform authority shall, together with other relevant authorities, formulate special incentive measures to promote the development of outsourcing platforms for the cell and gene industry. Contractual research and development institutions, contractual outsourcing manufacturers, contractual customized research and development manufacturers and other basic application platforms for the biomedicine industry shall be established or introduced at a faster pace, and shall be granted corresponding subsidies with financial funds if they meet relevant requirements.
Article 58 If imported reagents, consumables, instruments or devices necessary for the cell and gene industry meet biosecurity requirements, the customs shall set a green channel, simplify review procedures and reduce the review and import time.
Enterprises, scientific research institutions and medical and healthcare institutions that need to conduct cell and gene scientific research, clinical research, clinical trial or need to import or export producer goods throughout the year may apply to the municipal scientific and technological innovation authority, which shall make a list, notify the customs on a regular basis and assist the customs in crediting those who are placed on the list and in offering preferential treatment in customs clearance to those who have been certified by the customs.
Article 59 The policies on research and outcome deployment by scientific research institutions may be referred to by public medical and healthcare institutions that engage in clinical research, clinical trials or outcome deployment on cells and genes.
Article 60 It is encouraged to establish a performance incentive mechanism for clinical research and clinical trials on cells and genes in medical and healthcare institutions. The teams that conduct clinical research or clinical trials shall be granted more points.
Article 61 The municipal development and reform authority shall advance the holistic planning of the industrial spatial layout in this municipality, designate areas for building industry parks taking cell and gene as a characteristic, encourage the formation of innovation clusters of the cell and gene industry, and make major projects, major platforms and major resources of the cell and gene industry biased to such parks.
Article 62 Shenzhen Municipal People’s Government shall strive to establish a cooperation mechanism for the cell and gene industry in Guangdong-Hong Kong-Macao Greater Bay Area, explore cooperation opportunities in clinical research, clinical trials and industrial transformation, strengthen industrial linkage, and optimize the cross-regional industrial layout.
Article 63 The municipal and district people’s governments shall leverage the supporting role of government investment funds for the development of the cell and gene industry, attract social capital investment, and promote the research and development of cell- and gene-based products and outcome deployment.
Article 64 It is encouraged that financial institutions provide financial support for the development of the cell and gene industry, increase credit support, and reduce financing costs for enterprises.
It is encouraged that qualified cell and gene enterprises go listing.
Article 65 Efforts shall be made to strengthen the protection of intellectual property rights related to cells and genes, enhance coordination and cooperation among different authorities, severely crack down on infringements on intellectual property rights and protect the rights and interests of intellectual property rights holders in accordance with the law.
Financial services for intellectual property rights such as intellectual property rights pledging and intellectual property rights insurance for cell and gene enterprises shall be developed. Securitized financing products for intellectual property rights shall also be developed.
Chapter VIIILegal Liabilities
Article 66 In any of the following circumstances, the municipal public hygiene and health authority and the municipal market regulation authority shall, in accordance with their respective duties, order to stop the illegal act immediately and impose a fine of not less than 10,000 yuan but not more than 50,000 yuan:
1. The collector fails to meet the requirements specified in Article 13 of these Regulations;
2. Relevant matters are not clearly informed during sample collection;
3. Collected cells or outcome data are not stored according to relevant regulations.
Article 67 Any enterprise, scientific research institution, medical or healthcare institution or its staff member that violates any biosecurity law or regulation in the process of the research, development, production, marketing or use of cell- or gene-based products shall be punished in accordance with the Biosecurity Law of the People’s Republic of China, the Law of the People’s Republic of China on Guarding State Secrets, and the Regulations of the People’s Republic of China on the Management of Human Genetic Resources.
Article 68 Any medical or healthcare institution or its staff member that violates any medical law or regulation while engaging in medical treatment involving cells or genes shall be punished in accordance with the Law of the People’s Republic of China on Basic Medical and Healthcare and the Promotion of Health and the Regulations of Shenzhen Special Economic Zone on Medical Treatment.
Article 69 Any cell- or gene-based product manufacturer that violates any law or regulation on drug administration in the process of the research, development, production, marketing or use of the cell- or gene-based product shall be punished in accordance with the Drug Administration Law of the People’s Republic of China and the Regulations on the Implementation of the Drug Administration Law of the People’s Republic of China.
Article 70 Any enterprise, scientific research institution or medical or healthcare institution that conducts false or misleading publicity of the cell- or gene-based product shall be punished in accordance with the Anti-Unfair Competition Law of the People’s Republic of China and the Advertising Law of the People’s Republic of China.
Article 71 If any authority or its staff member abuses power, neglects duties, or engages in malpractice for personal gains in promoting the development of the cell and gene industry, the principal person directly in charge and other persons directly responsible shall be punished according to the law. If a crime is constituted, criminal responsibilities shall be investigated according to the law.
Chapter IXSupplementary Provisions
Article 72 These Regulations shall enter into force as of March 1, 2023.
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