Hunan Province Regulations on Promoting the Cell and Gene Industry

(July 31, 2025, the 14th People's Congress of Hunan Province) Adopted at the 17th Meeting of the Standing Committee

Chapter 1: General Provisions

Article 1: To promote the high-quality development of the cell and gene industry, effectively prevent and address biosecurity risks, and better meet the public's growing demand for healthy living, these Regulations are formulated based on the "Biosecurity Law of the People's Republic of China," the "Drug Administration Law of the People's Republic of China," and other relevant laws and administrative regulations, in light of the specific conditions of this province.

Article 2: This regulation applies to the research, development, production, storage, transportation, distribution, and use of cell and gene technologies and products (including pharmaceuticals and medical devices) used for the prevention and treatment of human diseases within the administrative territory of this province, as well as to related activities such as industry promotion and regulatory oversight.

Cell and gene technologies and products must comply with the standardization requirements stipulated by the "Standardization Law of the People's Republic of China" and shall not pose risks to public health, national security, or the broader social interests.

Article 3: The development of the cell and gene industries should adhere to the principles of scientific rigor, ethical compliance, safety and prudence, and service optimization.

Article 4: The Provincial People's Government shall strengthen overall coordination of the development of the cell and gene industry, integrate the growth of this industry into the national economic and social development plans, and formulate policy measures to promote its development, ensuring their effective implementation.

People's governments at the county level and above should strengthen safety management of cell and gene industry development, effectively preventing and addressing biosecurity risks.

Government departments at or above the county level—such as science and technology, health care, drug administration, and education—are responsible for legally overseeing the research, development, production, storage, transportation, distribution, and application of cell and gene technologies and products within their respective areas of responsibility. Meanwhile, departments including development and reform, industry and information technology, finance, human resources and social security, agriculture and rural affairs, market regulation, and medical insurance are tasked with supporting and advancing the development of the cell and gene industry according to their specific mandates.

The management authorities of the Xiangjiang New Area and the China (Hunan) Pilot Free Trade Zone will formulate and implement measures to promote the development of the cell and gene industries in their respective regions, in accordance with relevant national and provincial regulations.

Article 5: Entities engaged in the research, development, production, and provision of cell and gene technologies and products shall be responsible for ensuring the safety of their own R&D, production, and service activities involving these technologies and products. They must implement biosecurity risk control measures that comply with regulatory requirements, establish comprehensive systems for biosecurity training, ongoing monitoring and inspection, and regular reporting, and strengthen management throughout the entire process.

Article 6: People's governments at or above the county level, as well as the management authorities of Xiangjiang New Area, China (Hunan) Pilot Free Trade Zone, and relevant development zones, shall coordinate and integrate resources to enhance the collaborative innovation system involving government, industry, academia, research, and healthcare. They should encourage social entities to invest in innovation and industrial development within the cell and gene sectors, foster industry clustering, and promote coordinated growth across the upstream and downstream segments of the value chain.

Chapter 2: Cell Collection and Storage

Article 7: The collection of human blood, tissues, and other samples for cell acquisition through invasive or damaging procedures must be conducted by medical institutions that possess the appropriate qualifications and capabilities. If enterprises, research institutions, or universities need to carry out cell collection using such methods, they must entrust the task to a qualified medical institution with the necessary credentials and infrastructure. Medical institutions are required to perform cell-collection activities strictly within the scope of their licensed practice, ensuring compliance with relevant laws, regulations, standards, and medical technical guidelines.

The collection of tissue samples or bodily fluids naturally expelled, discharged, or secreted by the human body must comply with relevant legal regulations, and a comprehensive, end-to-end traceability system should be established.

Any organization or individual is strictly prohibited from engaging in illegal activities using cell collection.

Article 8: Before collecting cells, enterprises, research institutions, universities, and medical organizations must fully and accurately inform the individuals from whom cells are being collected—in a clear and understandable manner—about the purpose of collection, intended use, potential health implications, measures to protect personal privacy, and the rights and responsibilities of the donor. Written informed consent must also be obtained from the donor. If the donor lacks civil capacity, written informed consent from their legal guardian is required; if the donor has limited civil capacity, both the individual’s and their guardian’s written consent must be secured.

Article 9: Enterprises, research institutions, universities, medical institutions, and other entities engaged in cell collection, storage, and transportation services shall establish management systems that comply with national and provincial regulations regarding cell collection, storage, transportation, registration, and traceability. They must also set up a quality control system, standard operating procedures, and emergency response plans, and ensure they are equipped with qualified personnel, facilities, equipment, and instruments as required. Meanwhile, the science and technology, health, drug administration, education, market supervision, and transportation departments under the governments at or above the county level shall strengthen guidance and oversight in this area.

The management measures for cell collection, storage, and transportation will be formulated separately by the health department of the provincial people's government in collaboration with departments including science and technology, drug administration, education, market supervision, and transportation.

Chapter 3: Cell and Gene Product Development

Article 10: Support the conduct of basic research in cell and gene sciences, and encourage enterprises, research institutions, universities, healthcare organizations, and researchers to strengthen their efforts in groundbreaking, original research as well as cutting-edge, interdisciplinary studies in the cell and gene field.

Support enterprises, research institutions, universities, and healthcare organizations in collaborating on cell and gene clinical research and clinical trials.

Healthcare professionals are encouraged to conduct cell and gene clinical research and trials in accordance with regulations, and their involvement in these activities can be recognized as valid achievements for professional technical qualification assessments and job appointments.

Article 11: Clinical research and clinical trials involving cells and genes shall be conducted at Grade-III medical institutions and must be filed with both the national health authority and the drug regulatory department.

The provincial government's health authority should collaborate with relevant departments to formulate policies that encourage tertiary medical institutions to conduct cell and gene clinical research and trials, establish internal clinical research management units, and set up research-oriented patient wards.

Medical institution beds used for clinical research or clinical trials may, upon approval by the provincial people's government's health authority, be excluded from performance evaluations related to metrics such as the average length of hospital stay, bed turnover rate, bed occupancy rate, and associated costs.

Article 12: When conducting clinical research and clinical trials involving cells and genes, it is mandatory to first carry out scientific and ethical reviews in accordance with relevant national and provincial regulations. Researchers must strictly adhere to approved operating procedures and management systems, ensuring comprehensive quality management and robust risk control throughout the entire process.

Article 13: When conducting clinical research and clinical trials involving cells and genes, a robust mechanism for safeguarding the rights and interests of research participants must be established. Researchers shall respect and fully protect the right to informed consent and the right to autonomous decision-making of both the participants themselves and their legal guardians. The informed consent process must be strictly adhered to, and no deceptive, coercive, or manipulative tactics—such as deception, inducement, or threats—may be used to compel participants or their guardians to agree to take part in the study. Furthermore, all personal information related to research participants must be kept strictly confidential. Participants retain the right to withdraw from the study at any stage without providing any explanation or justification. After withdrawal, any remaining samples collected from the participant must be destroyed or de-identified in accordance with the law.

If research participants suffer harm as a result of clinical studies or clinical trials, the clinical research institution, clinical trial organization, or clinical trial sponsor shall cover the participants' medical treatment costs and provide appropriate financial compensation or indemnification. Additionally, companies, research institutions, universities, medical facilities, and other entities are encouraged to purchase relevant liability insurance for participants involved in clinical studies and trials.

Article 14: We encourage the effective accumulation of real-world data in cell and gene clinical research, enhancing the applicability of such data to provide robust safety and efficacy evidence for the registration of cell and gene products—or to support updates to the labeling of already-marketed products.

Article 15: Clinical trials involving cells and genes shall comply with the state's relevant regulations on quality management for clinical trials of drugs and medical devices. The preparation of formulations used in clinical research involving cell and gene technologies must also adhere to national guidelines.

Chapter 4: Expanded Use and Expanded Clinical Trials

Article 16: The expanded use and expanded clinical trials of cell and gene products shall adhere to the principles of safety, voluntariness, and effectiveness, and must comply with national regulations governing quality management in clinical trials of drugs and medical devices.

For cell and gene products currently undergoing clinical trials to treat life-threatening diseases with no existing effective treatments—where medical observation suggests potential benefits and ethical principles are upheld—these products may, after review and informed consent, be made available for expanded use or expanded clinical trials within the medical institutions conducting the trials, benefiting other patients who do not participate in the clinical trial but have the same condition. Additionally, cell and gene products that have already demonstrated promising interim results may be prioritized for expanded use or expanded clinical trials.

Article 17: Before conducting expanded use of cell and gene products or initiating expanded clinical trials, medical institutions and clinical trial sponsors must fully and accurately inform patients—in clear and understandable terms—about the potential benefits, risks, adverse reactions, and available remedies, as well as other essential factors that may influence their decision-making. Additionally, they must provide patients with a detailed explanation regarding the sources and possible consequences of these risks.

After fully understanding the circumstances outlined above, patients who agree to the expanded use of cell and gene products or to participate in expanded clinical trials must sign an informed consent form. If the patient lacks civil capacity, written informed consent must be obtained from their legal guardian; if the patient has limited civil capacity, both the patient and their guardian must provide written informed consent.

Article 18: The provincial people's government's departments of health and drug administration shall, in accordance with their respective responsibilities, strengthen supervision, management, and guidance services related to the expanded use of cell and gene products, as well as expanded clinical trials. They shall also ensure that medical institutions and clinical trial sponsors safeguard patients' legitimate rights and interests.

Article 19: Patients may, at any time and without conditions, request the cessation of expanded use of cell and gene products, as well as expanded clinical trials. Medical institutions and clinical trial sponsors shall inform patients about potential risks, adverse reactions, available remedies, and other relevant information following discontinuation, and must promptly halt such use.

Article 20: Cell and gene products shall have their expanded use and expanded clinical trials terminated if any of the following circumstances apply:

(1) Serious, unexpected adverse reactions occur;

(II) The ongoing clinical trial protocol has undergone significant adjustments, yet the corresponding expanded access and expanded clinical trial protocols have not been re-evaluated.

(III) Recent research indicates that expanded access programs and expanded clinical trials raise ethical or scientific concerns.

(IV) Cell and gene products have received approval from the national drug regulatory authority for market launch;

(5) Cell and gene product registration has not been approved;

(6) Other circumstances under which termination should occur.

Article 21: Medical institutions and clinical trial sponsors conducting expanded access to cell and gene therapies, as well as expanded clinical trials, shall accurately and thoroughly document all relevant details to provide informative references for product market approval.

Chapter 5: Applications and Production

Article 22: Support enterprises, research institutions, universities, and medical organizations in conducting research and applications related to cell and gene technologies, as well as in developing cell and gene technologies with core intellectual property rights, along with associated equipment, software, and databases.

Encourage enterprises, research institutions, universities, and medical organizations to participate in developing international, national, local, industry, and organizational standards related to cell and gene technologies.

Article 23: Gene sample collection and genetic testing institutions must implement necessary measures, such as de-identification, during the handling of sample transfers and the transmission of testing information. They are strictly prohibited from illegally providing such information to third parties, ensuring the security of genetic information and data while safeguarding the privacy rights of individuals tested.

The use of genetic sequencing information must be authorized in writing by the individual being tested or their legal guardian.

No organization or individual shall, based on genetic testing results, restrict or deprive individuals of their legitimate rights and interests in areas such as education and employment.

Article 24: Any judgments regarding disease risk, medication plans, nutritional metabolism, reproductive risks, and other factors based on genetic sequencing results must be supported by sound scientific evidence, along with a clear indication of the source of that evidence.

Support medical and healthcare institutions in utilizing genetic diagnostic technologies to aid clinical diagnosis.

Article 25: Enterprises and research institutions shall, in accordance with the Marketing Authorization Holder system for pharmaceuticals or the Registration and Filing System for medical devices, either conduct cell and gene product manufacturing themselves or entrust qualified enterprises to do so. In cases of contract manufacturing, a contract agreement and a quality agreement must be signed to ensure the safety and quality of the products.

To engage in the manufacturing of pharmaceuticals and Class II and Class III medical devices, one must obtain a production license approved by the drug supervision and administration department of the provincial people's government.

Article 26: The production of cell and gene products shall comply with the state's relevant regulations on quality management for pharmaceuticals and medical devices, as well as the requirements outlined in the associated appendices.

Cell and gene product manufacturers should establish a risk assessment system, develop and implement risk control measures, and eliminate factors that could compromise product quality.

Article 27: Producers of cell and gene products shall establish a comprehensive quality control system covering the entire process—from sample reception, transportation, and storage to product manufacturing, testing, release, storage, and shipment.

Cell and gene product manufacturers should establish digital management and traceability systems to comprehensively document, track, evaluate, and manage product quality, ensuring that all-process information remains authentic, accurate, complete, and readily traceable—and to publicly disclose relevant product information as required by applicable regulations.

Chapter 6: Scientific Review and Ethical Review

Article 28: People's governments at the county level and above, through their departments of science and technology, health, drug administration, education, industry and information technology, agriculture and rural affairs, and others, shall be responsible for guiding and overseeing the ethical practices related to cell and gene technologies within enterprises, research institutions, universities, and medical and healthcare organizations, in accordance with their respective duties and responsibilities.

The provincial People's Government departments of science and technology, health, drug administration, and others have established science and ethics expert committees according to their respective responsibilities. These committees provide technical support and policy advisory services—such as assisting in refining ethical governance policies and regulations for cell and gene technologies, developing standardized guidelines, and conducting case investigations and risk management—to ensure robust oversight and decision-making in this critical area.

Article 29: Enterprises, research institutions, universities, and healthcare organizations are responsible for managing ethical review processes related to cell and gene technologies within their respective institutions. They must establish academic committees and ethics review boards in accordance with relevant national regulations, ensuring that all cell and gene clinical research and clinical trial projects submitted by their organizations undergo rigorous scientific and ethical reviews. Additionally, the ethics review boards are required to register or file their activities as mandated by national and provincial regulations.

Enterprises, research institutions, universities, and healthcare organizations should strengthen the day-to-day management of ethical review committees conducting ethics reviews for cell- and gene-related research, regularly assessing the quality and efficiency of their work. They should promptly provide feedback or recommendations for improvement when issues are identified, and, as needed, make adjustments to the composition of the ethics review committee or its members.

Members of the ethics review committee must not participate in the review of research projects with which they have a financial interest or conflict of interest.

Article 30: Units conducting cell and gene-related research, if they have not established an ethics review committee or if their existing committee is unable to adequately handle the review requirements, may, in writing, entrust a competent institutional ethics review committee or a regional ethics review committee to carry out the ethical review process.

Article 31: The Ethics Review Committee shall conduct an ethical review of cell and gene clinical research and clinical trial projects within 30 days from the date of application receipt, and issue a review opinion accordingly.

Article 32: When multiple organizations collaborate on cell and gene technology activities, the leading organization may establish a collaborative mechanism for scientific and ethical review, as appropriate, to enhance coordinated management of such reviews.

Explore the implementation of mutual recognition for ethical reviews of cell and gene clinical research and clinical trials.

Chapter 7: Safeguard Measures

Article 33: County-level or higher people's governments and their relevant departments, where conditions permit, shall, based on the development trends of the cell and gene industry and tailored to local circumstances, refine policies related to industry development, project support, financial incentives, innovation encouragement, and talent recruitment. They should also strengthen organizational coordination, clearly define responsible entities, and actively promote the high-quality growth of the cell and gene industry.

Article 34: Key laboratories, pilot-scale testing facilities, inspection and testing centers, and other industry service platforms are encouraged to provide cell and gene R&D services, as well as productive services, to enterprises, research institutions, universities, and medical organizations.

Article 35: People's governments at the county level and above, along with their relevant departments, shall refine supporting policies tailored to talent needs, providing robust support for both attracting and nurturing talent. Specifically, personnel required by the cell and gene industries will be prioritized for enhanced assistance. Recognized talents will enjoy corresponding policy benefits in areas such as employment and entrepreneurship, housing, healthcare, project applications, and access to awards.

Article 36: People's governments at the county level and above should fully leverage the supporting role of government investment funds in industrial development. They should prioritize support for cell and gene technologies and products that have already received clinical trial approvals or clinical research filings, while also guiding social capital to invest in the cell and gene industry, thereby fostering product R&D and accelerating the commercialization of scientific and technological breakthroughs.

Article 37: Financial institutions are encouraged to provide financial support for the development of the cell and gene industry, increasing credit support and helping to reduce financing costs for enterprises.

Encourage insurance companies to develop insurance products tailored to the cell and gene industry, including clinical research liability insurance, clinical trial liability insurance, product liability insurance, and commercial health insurance.

Article 38: People's governments at or above the county level, along with their departments of science and technology, health care, drug supervision and administration, and development and reform, shall, within the scope of their respective responsibilities, streamline review and approval processes and enhance the efficiency of these procedures.

The provincial people's government's drug supervision and administration department should strengthen guidance and services for cell and gene product applicants in preparing for review and approval, and assist applicants in maintaining thorough communication with the review agencies of the National Medical Products Administration.

For cell and gene products that meet criteria such as breakthrough therapy designation, conditional approval for market entry, or priority review and approval standards, the provincial government’s drug regulatory authority may intervene early to guide applicants in submitting requests to the National Medical Products Administration for expedited marketing registration. Additionally, a streamlined and efficient consultation channel will be established to assist applicants in accelerating the launch of these innovative products.

Article 39: Imported reagents, consumables, instruments, and equipment required by the cell and gene industries, provided they comply with relevant national laws and regulations on biosafety, data security, and other applicable areas, shall receive customs clearance support in accordance with the law.

Support is provided for conducting international collaborative exchanges and cooperation in areas such as the Xiangjiang New Area and the China (Hunan) Pilot Free Trade Zone, in accordance with relevant regulations, including major disease-related international multi-center clinical studies and clinical trials.

Article 40: County-level or higher people's governments that have the necessary conditions should establish and improve a "chain leader" system for the cell and gene industry chain, building a comprehensive, end-to-end industrial incubation framework. Led by leading enterprises, this system will foster distinctive, competitive industries while supporting businesses and research institutions in tackling key technological challenges related to essential reagents, consumables, and specialized equipment.

Article 41: Support enterprises and medical institutions in leveraging cell and gene technologies and products to develop preventive and therapeutic applications for major diseases such as birth defects and cancer.

As part of new medical technology initiatives such as cell and gene therapy, once these projects are legally approved for clinical application and standardized into specific medical technology protocols, healthcare institutions can submit them to the medical insurance authorities for inclusion under newly established medical service pricing categories. In turn, the medical insurance departments are expected to streamline administrative processes, deliver high-quality services, and systematically integrate eligible medical service items into the national health insurance coverage framework.

Article 42: People's governments at or above the county level and their intellectual property protection departments shall strengthen intellectual property protection in the fields of cells and genetics, enhance inter-departmental coordination, vigorously crack down on intellectual property infringement, and safeguard the rights and interests of intellectual property rights holders in accordance with the law.

The Provincial Intellectual Property Protection Center should support enterprises in the cell and gene industry to apply for fast-track pre-examination services, guide these companies in enhancing the quality of their patent applications, and improve both the quality and efficiency of patent pre-examination services. Additionally, the center should assist these enterprises in strengthening their intellectual property protection capabilities and bolstering their ability to manage risks effectively.

Article 43: The provincial people's government, through its departments of science and technology, drug administration, and others, shall intensify support for the establishment of cell and gene testing and diagnostic institutions. It will also encourage these institutions to participate in or lead the development of international, national, local, industry, and organizational standards for cell and gene products, as well as assist with applications for related qualifications such as technical arbitration and national biologic product lot release certification.

Drug testing and inspection institutions that have obtained national qualifications such as the batch release authorization for biological products should, in accordance with the law, assist drug regulatory authorities in fulfilling their oversight responsibilities, guide enterprises in enhancing their quality management systems, and provide efficient and convenient services to support the market launch of cell and gene-based products.

Article 44: Construction and introduction of qualified, professional inspection and testing institutions are encouraged to provide services for the inspection and testing of cell and gene products.

Promote the establishment of a cell and gene product testing and inspection platform, led primarily by provincial drug testing and inspection institutions, with participation from other qualified, specialized testing and inspection organizations. This platform will conduct research and provide services focused on testing methodologies, quality standards, and safety evaluation technologies, thereby enhancing overall testing and inspection capabilities.

Article 45: Cell and gene-related industry organizations should play a key role in academic exchanges, talent development, policy recommendations, standard-setting, and self-regulatory management.

Article 46: People's governments at or above the county level and their relevant departments, industry associations, media outlets, and other entities shall strengthen publicity of laws and regulations related to biosafety, pharmaceutical safety, management of human genetic resources, and promote public awareness of associated knowledge.

Promotion and introduction of cell and gene technologies and products must be objective, truthful, and accurate—unauthorized or misleading advertising is strictly prohibited.

Article 47: Government departments at or above the county level—such as those responsible for science and technology, health, drug supervision, and education—and their staff members who abuse their authority, neglect their duties, or engage in corruption while promoting the cell and gene industry shall be disciplined according to law, with penalties imposed on the directly responsible supervisors and other individuals bearing direct responsibility.

Other acts that violate these regulations, for which legal or administrative regulations already stipulate liability, shall be governed by those provisions.

Chapter 8 Supplementary Provisions

Article 48: These Regulations shall come into effect on October 1, 2025.