Hunan Province Enacts Regulations to Promote Cell and Gene Industry, Effective October 1, 2025

According to Hunan Daily, on July 31, the 17th Meeting of the Standing Committee of the 14th People’s Congress of Hunan Province voted to adopt the Regulations of Hunan Province on Promoting the Cell and Gene Industry, which will come into effect on October 1, 2025.

The full text of the regulations is as follows:

Regulations of Hunan Province on Promoting the Cell and Gene Industry

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

Chapter I General Provisions

Article 1 To promote the high-quality development of the cell and gene industry, effectively prevent and respond to biosafety risks, and better meet the people’s needs for a healthy life, these Regulations are formulated in accordance with 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, taking into account the actual conditions of this Province.

Article 2 This Regulation shall apply to the research and development, production, storage, transportation, distribution, and use of cell and gene technologies and products (including pharmaceuticals and medical devices) for the prevention, diagnosis, and treatment of human diseases within the administrative area of this Province, as well as to related activities such as industry promotion and supervision and administration.

Cell and gene technologies and products shall comply with the standardization requirements stipulated in the Standardization Law of the People's Republic of China, and shall not endanger public health, national security, or social public interests.

Article 3 The promotion of the development of the cell and gene therapy industry shall adhere to the principles of scientific standardization, ethical compliance, safety and prudence, and service optimization.

Article 4 The people's government of the province shall strengthen overall coordination for the development of the cell and gene industry, incorporate such development into the national economic and social development plan, formulate policy measures to promote industrial development, and organize their implementation.

People's governments at or above the county level shall strengthen safety management of the cell and gene therapy industry, and effectively prevent and respond to biosafety risks.

Science and technology, health, drug supervision and administration, education, and other departments of people's governments at or above the county level shall, within the scope of their respective duties, exercise regulatory oversight in accordance with the law over the research and development, production, storage, transportation, distribution, and use of cell and gene technologies and products; development and reform, industry and information technology, finance, human resources and social security, agriculture and rural affairs, market regulation, healthcare security, and other departments shall, within the scope of their respective duties, carry out work related to the development of the cell and gene industries.

The administrative bodies of Xiangjiang New Area and the China (Hunan) Pilot Free Trade Zone shall formulate and implement measures to promote the development of the cell and gene therapy industries within their respective jurisdictions, in accordance with relevant national and provincial regulations.

Article 5 Entities engaged in the research, development, production, and services of cell and gene technologies and products shall be responsible for the safety of such activities within their organizations. They shall implement biosafety risk prevention and control measures in compliance with applicable regulations, establish work systems for biosafety training, follow-up inspections, and regular reporting, and strengthen whole-process management.

Article 6 People's governments at or above the county level, as well as the administrative committees of Xiangjiang New Area, China (Hunan) Pilot Free Trade Zone, and relevant development zones, shall coordinate and integrate resources, improve the collaborative innovation system involving government, industry, academia, research, and healthcare, encourage social investment in innovation and industrial development in the fields of cells and genes, promote industrial agglomeration, and foster coordinated development across the upstream and downstream segments of the industrial chain.

Chapter 2 Cell Collection and Storage

Article 7 The collection of human samples, such as blood and tissues, through traumatic or invasive means for the purpose of obtaining cells shall be conducted by medical institutions with corresponding qualifications and conditions. Enterprises, scientific research institutions, and higher education institutions that need to carry out cell collection through the aforementioned means shall entrust medical institutions with corresponding qualifications and conditions to perform such procedures. Medical institutions shall conduct cell collection activities within the scope of their practice registration and comply with relevant laws, regulations, standards, and medical technical specifications.

The collection of tissue samples or body fluids expelled, discharged, or secreted by the human body itself shall comply with relevant legal provisions, and a full-process traceability system shall be established.

It is strictly prohibited for any entity or individual to engage in illegal activities through cell collection.

Article 8 Before collecting cells, enterprises, scientific research institutions, higher education institutions, and medical institutions shall fully and accurately inform the donors, in plain language, of the purpose and intended use of the collection, potential health impacts, measures for protecting personal privacy, and the rights and obligations of the donors, and shall obtain written informed consent from the donors. If a donor is a person without capacity for civil conduct, written informed consent shall be obtained from their guardian; if a donor is a person with limited capacity for civil conduct, written informed consent shall be obtained from both the donor and their guardian.

Article 9 Enterprises, scientific research institutions, higher education institutions, medical institutions, and other entities engaged in cell collection, storage, and transportation shall establish management systems for cell collection, storage, transportation, registration, and traceability that comply with national and provincial regulations; establish quality control systems, standard operating procedures, and emergency response plans; and be staffed with qualified personnel and equipped with premises, facilities, equipment, and instruments that meet regulatory requirements. The science and technology, health, drug supervision and administration, education, market regulation, and transport departments of people’s governments at or above the county level shall strengthen guidance and oversight.

Administrative Measures for the Collection, Storage, and Transportation of Cells shall be formulated separately by the health department of the provincial people’s government in conjunction with the departments responsible for science and technology, drug supervision and administration, education, market regulation, and transportation.

Chapter 3 Research and Development of Cell and Gene Products

Article 10 Support shall be provided for basic research in cell and gene therapy, and enterprises, scientific research institutions, higher education institutions, medical and health institutions, as well as scientific researchers are encouraged to strengthen major original research and frontier interdisciplinary research in the fields of cells and genes.

Support enterprises, research institutions, universities, and medical and health institutions in collaborating to conduct clinical research and clinical trials on cells and genes.

Support medical and health professionals in conducting cell and gene clinical research and clinical trials in accordance with regulations, and the progress of such work may serve as valid performance records for professional technical qualification evaluation and job appointment.

Article 11 Clinical research and clinical trials involving cells and genes shall be conducted at tertiary medical institutions and filed with the national health administrative department and the drug regulatory department.

The health administrative department of the provincial people's government shall, in conjunction with relevant departments, formulate policies to encourage tertiary medical institutions to conduct clinical research and clinical trials on cells and genes, and to establish internal clinical research management bodies and research wards.

Hospital beds in medical institutions used for clinical research or clinical trials may be excluded from performance assessments—such as average length of stay, bed turnover rate, bed occupancy rate, and related cost indicators—upon certification by the provincial health administrative department.

Article 12 For the conduct of clinical research and clinical trials involving cells and genes, scientific review and ethical review shall be conducted in advance in accordance with relevant national and provincial regulations; standard operating procedures and management systems that comply with applicable requirements shall be strictly implemented; and whole-process quality management and risk control shall be carried out.

Article 13 In conducting clinical research and clinical trials involving cells and genes, institutions shall establish and improve mechanisms to safeguard the rights and interests of research participants, respect and protect the right to informed consent and the right to autonomous decision-making of research participants or their guardians, strictly adhere to informed consent procedures, and shall not use deception, inducement, coercion, or other means to obtain consent from research participants or their guardians for participation in the research. Strict confidentiality shall be maintained regarding information related to research participants. Research participants may withdraw from the study unconditionally at any stage; upon withdrawal, remaining samples from the research participants shall be destroyed or de-identified in accordance with applicable laws.

Where clinical research or clinical trials cause harm to study participants, the clinical research institution, clinical trial institution, or clinical trial sponsor shall bear the treatment costs for the study participants and provide corresponding economic compensation or damages. Enterprises, scientific research institutions, higher education institutions, medical institutions, and other entities are encouraged to purchase relevant liability insurance for study participants involved in clinical research and clinical trials.

Article 14 Efforts shall be encouraged to promote the effective accumulation of real-world data in cell and gene therapy clinical research, enhance the applicability of real-world data, and provide evidence of safety and efficacy for the registration of cell and gene therapy products or support changes to the package inserts of marketed products.

Article 15 Clinical trials of cell and gene therapies shall comply with the relevant national provisions on quality management for clinical trials of drugs and medical devices. The preparation of formulations for clinical research involving cell and gene technologies shall comply with the relevant national provisions.

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 efficacy, and comply with the relevant national regulations on quality management for clinical trials of drugs and medical devices.

For cell and gene therapy products currently undergoing clinical trials to treat diseases that are seriously life-threatening and for which no effective treatments are available, if medical observation suggests potential benefit and ethical principles are met, such products may be used for other patients with the same condition who are not participating in the clinical trials, through expanded access or expanded clinical trials within the medical institutions conducting the trials, following review and informed consent. Priority may be given to expanded access or expanded clinical trials for cell and gene therapy products that have achieved phased results.

Article 17 Prior to the expanded use or expanded clinical trials of cell and gene therapy products, medical institutions and clinical trial sponsors shall comprehensively and accurately inform patients, in plain language, of essential matters affecting their decision-making, including the potential benefits, risks, adverse reactions, and remedial measures associated with the use of such products. They shall also provide patients with detailed explanations regarding the sources and consequences of these risks.

Where a patient, having been fully informed of the circumstances set forth in the preceding paragraph, consents to the expanded access use or expanded clinical trial of cell and gene therapy products, an informed consent form shall be signed. If the patient is a person without capacity for civil conduct, written informed consent shall be obtained from their guardian; if the patient is a person with limited capacity for civil conduct, written informed consent shall be obtained from both the patient and their guardian.

Article 18 The health administrative and drug regulatory departments of the provincial people’s government shall, in accordance with their respective duties, strengthen supervision, administration, and guidance services for the expanded access use and expanded-access clinical trials of cell and gene products, and urge medical institutions and clinical trial sponsors to safeguard the lawful rights and interests of patients.

Article 19 Patients may, at any time and unconditionally, request the discontinuation of the expanded access use or expanded clinical trials of cell and gene therapy products. Medical institutions and clinical trial sponsors shall inform patients of the potential risks, adverse reactions, and remedial measures associated with discontinuation, and shall promptly discontinue such use or trials.

Article 20 The expanded use and expanded clinical trials of cell and gene products shall be terminated under any of the following circumstances:

(1) Occurrence of serious, unexpected adverse reactions;

(2) Significant adjustments were made to the protocols of ongoing clinical trials, but no re-evaluation was conducted for the corresponding expanded access use and expanded access clinical trial protocols;

(3) Recent studies have indicated that expanded access and expanded clinical trials present ethical or scientific concerns;

(4) Cell and gene therapy products have obtained marketing approval from the National Medical Products Administration;

(5) Cell and gene therapy products have not received regulatory approval for registration;

(6) Other circumstances under which termination shall occur.

Article 21 Medical institutions and clinical trial sponsors conducting expanded access and expanded clinical trials of cell and gene therapy products shall accurately and thoroughly document relevant information to provide reference data for product marketing approval.

Chapter 5 Applications and Production

Article 22 Support shall be provided to enterprises, scientific research institutions, higher education institutions, and medical institutions in conducting research on and applications of cell and gene technologies, and in developing cell and gene technologies with core intellectual property rights, as well as related equipment, software, and databases.

Encourage enterprises, scientific research institutions, higher education institutions, and medical institutions to participate in the development of international, national, local, industrial, and group standards related to cell and gene technologies.

Article 23 Gene sample collection institutions and gene testing institutions shall take necessary measures, such as de-identification, during the circulation of test samples and the transmission of testing information. They are strictly prohibited from illegally providing such information to third parties, so as to ensure the security of genetic information and data and protect the privacy rights of the individuals tested.

The use of gene sequencing information shall be subject to the written consent of the examinee or their guardian.

No entity or individual shall restrict or deprive individuals of their lawful rights and interests in education, employment, and other areas based on genetic test results.

Article 24 Where judgments regarding disease risk, medication regimens, nutritional metabolism, reproductive risks, and other factors are made based on gene sequencing results, there shall be a scientific and reasonable basis, and the source of such basis shall be disclosed.

Support medical and health institutions in utilizing genetic diagnostic technologies to assist clinical diagnosis.

Article 25 Enterprises and scientific research institutions shall, in accordance with the Marketing Authorization Holder (MAH) system for drugs or the Registrant and Filer system for medical devices, independently conduct or entrust other qualified enterprises to carry out the production of cell and gene therapy products. In cases of entrusted production, an entrustment agreement and a quality agreement shall be executed to ensure product quality and safety.

To engage in the production of drugs and Class II and Class III medical devices, approval must be obtained from the drug regulatory department of the people's government at the provincial level, and a Production License must be acquired.

Article 26 The manufacturing of cell and gene products shall comply with the relevant national regulations on quality management for the production of drugs and medical devices, as well as the requirements of related appendices.

Manufacturers of cell and gene therapy products shall establish a risk assessment system, formulate and implement risk prevention and control measures, and eliminate risk factors that affect product quality.

Article 27 Manufacturers of cell and gene products shall establish a comprehensive quality control system covering the entire process of sample receipt, transportation, and storage, as well as product manufacturing, testing, release, storage, and transportation.

Manufacturers of cell and gene therapy products shall establish digital management systems and traceability systems to comprehensively record, track, evaluate, and manage product quality, ensuring the authenticity, accuracy, completeness, and traceability of information throughout the entire process, and disclose relevant product information in accordance with applicable regulations.

Chapter 6 Scientific Review and Ethical Review

Article 28 The departments of science and technology, health, drug supervision and administration, education, industry and information technology, agriculture and rural affairs, and other relevant departments of the people's governments at or above the county level shall, in accordance with their respective duties and authorities, be responsible for providing guidance on, and supervising and administering, the ethical oversight of cell and gene technologies by enterprises, scientific research institutions, institutions of higher learning, and medical and health institutions.

The science and technology, health, and drug supervision and administration departments of the provincial people’s government shall, in accordance with their respective responsibilities, establish scientific and technological ethics expert committees to provide technical support and decision-making advisory opinions for improving policies, regulations, norms, and standards governing the ethical oversight of cell and gene technologies, as well as for conducting case investigations and risk management.

Article 29 Enterprises, scientific research institutions, higher education institutions, and medical and health institutions shall serve as the primary entities responsible for the ethical review and management of cell and gene technologies within their respective organizations. They shall establish academic committees and ethics review committees in accordance with relevant national regulations to conduct scientific and ethical reviews of cell and gene clinical research and clinical trial projects submitted by their institutions. The ethics review committees shall be filed or registered in accordance with relevant national and provincial regulations.

Enterprises, scientific research institutions, higher education institutions, and medical and health institutions shall strengthen the daily management of ethical reviews conducted by their Ethics Review Committees for cell and gene-related research, regularly assess the quality and efficiency of such work, promptly provide improvement opinions or suggestions for any issues identified, and adjust the composition of the Ethics Review Committee or its members as needed.

Members of the Ethics Review Committee shall not participate in the review of research projects in which they have a conflict of interest or vested interest.

Article 30 Where an entity conducting cell and gene-related research has not established an ethics review committee, or where its ethics review committee is unable to meet the requirements for review, the relevant entity may, in writing, entrust a competent institutional ethics review committee or a regional ethics review committee to conduct the ethics review.

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

Article 32 Where multiple entities collaborate in conducting cell and gene technology activities, the lead entity may establish a collaborative mechanism for scientific and technological ethics review based on actual circumstances, so as to strengthen the coordinated management of such ethics reviews.

Explore the implementation of mutual recognition of ethical review results for clinical research and clinical trials involving cells and genes.

Chapter 7 Safeguard Measures

Article 33 People's governments at or above the county level and their relevant departments, where conditions permit, shall improve policies regarding industrial development, project support, financial assistance, innovation incentives, and talent recruitment in light of the development trends of the cell and gene industry and local realities; strengthen organizational coordination; clarify responsible entities; and promote high-quality development of the cell and gene industry.

Article 34 Support industrial service platforms, such as key laboratories, pilot-scale test bases, and inspection and testing centers, in providing cell and gene R&D services and production-oriented services to enterprises, scientific research institutions, higher education institutions, and medical institutions.

Article 35 People's governments at or above the county level and their relevant departments shall improve supporting policies for talent, support the introduction and cultivation of talent, and include talents required by the cell and gene industry within the scope of key support. Talents recognized by the relevant departments shall enjoy corresponding policy preferences in areas such as employment and entrepreneurship, housing, medical care, and project and award applications.

Article 36 People's governments at or above the county level shall give full play to the supportive role of government investment funds in industrial development, provide key support to cell and gene technologies and products that have obtained clinical trial approvals or completed clinical study filings, guide social capital into the cell and gene industry, and promote product research and development as well as the commercialization of scientific and technological achievements.

Article 37 Financial institutions are encouraged to provide financial support for the development of the cell and gene therapy industry, strengthen credit support, and reduce corporate financing costs.

Encourage insurance companies to develop insurance products related to the cell and gene therapy industry, such as clinical study liability insurance, clinical trial liability insurance, product liability insurance, and commercial health insurance.

Article 38 The departments of science and technology, health, drug supervision and administration, development and reform, and other relevant departments of the people's governments at or above the county level shall optimize review and approval processes and improve review and approval efficiency within the scope of their respective duties.

The drug regulatory department of the provincial people's government shall strengthen guidance and services for cell and gene therapy product marketing authorization applicants in their preparation for review and approval, and guide applicants to engage in full communication with the review institutions of the National Medical Products Administration.

For cell and gene therapy products that meet the criteria for Breakthrough Therapy Designation, Conditional Approval, or Priority Review, the drug regulatory department of the provincial people's government may intervene early to guide applicants in submitting applications for accelerated marketing registration to the National Medical Products Administration (NMPA), and establish convenient and unobstructed consultation channels to help applicants accelerate the market launch of relevant products.

Article 39 Where imported reagents, consumables, instruments, and equipment required by the cell and gene therapy industry comply with relevant laws and regulations on national biosafety, data security, and other related matters, Customs shall facilitate customs clearance in accordance with the law.

Support the conduct of international exchanges and cooperation, as well as international multicenter clinical research and clinical trials for major diseases, in areas such as the Xiangjiang New Area and the China (Hunan) Pilot Free Trade Zone, in accordance with relevant regulations.

Article 40 County-level or higher people’s governments with the necessary conditions shall establish and improve the chain chief system for the cell and gene industry chain, build a whole-chain industrial incubation system, cultivate distinctive and competitive industries led by leading enterprises, and support enterprises and scientific research institutions in conducting key technological breakthroughs in core areas such as critical reagents, consumables, and instruments and equipment.

Article 41 Support shall be provided for enterprises and medical institutions to utilize cell and gene technologies and products in the prevention and treatment of major diseases, including birth defects and tumors.

Medical new technology projects, such as those involving cellular and gene-based diagnostic and therapeutic techniques, shall be approved for clinical application in accordance with the law. Once standardized as medical technology projects, healthcare institutions shall submit them to the healthcare security authorities for project establishment as newly added medical service price items. The healthcare security authorities shall improve administrative efficiency, provide high-quality services, and include eligible medical service items in the national medical insurance catalog in accordance with established procedures.

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

Provincial Intellectual Property Protection Centers shall support enterprises in the cell and gene therapy industries in applying for eligibility as fast-track pre-examination service entities, guide these enterprises to improve the quality of their patent applications, enhance the quality and efficiency of patent pre-examination services, and assist them in strengthening their intellectual property protection capabilities and risk response capacities.

Article 43 The science and technology, drug supervision and administration, and other departments of the people's governments at the provincial level shall strengthen support for the establishment of cell and gene testing and inspection institutions, and support their participation in or organization of the formulation of international, national, local, industrial, and group standards for cell and gene products, as well as applications for relevant qualifications such as technical arbitration and national lot release authorization for biological products.

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

Article 44 Encourage the establishment and introduction of qualified professional inspection and testing institutions to provide inspection and testing services for cell and gene products.

Promote the establishment of a testing and inspection platform for cell and gene products, with provincial drug testing and inspection institutions as the main body and participation from other qualified professional testing and inspection institutions, to carry out research and services on testing methods, quality standards, and safety evaluation technologies, thereby enhancing testing and inspection service capabilities.

Article 45 Industry organizations related to cells and genes shall play a 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, news media, and other entities shall strengthen publicity of laws and regulations concerning biosafety, drug safety, and the management of human genetic resources, as well as popularize related knowledge.

Promotion and marketing of cell and gene technologies and products shall be objective, truthful, and accurate; false or misleading publicity is prohibited.

Article 47 Where staff members of the science and technology, health, drug supervision and administration, education, and other departments of people's governments at or above the county level abuse their powers, neglect their duties, or engage in favoritism and irregularities in the work of promoting the cell and gene industry, the persons directly in charge and other directly responsible persons shall be subject to disciplinary sanctions in accordance with the law.

For other acts in violation of these Regulations, where laws and administrative regulations have already prescribed legal liabilities, such provisions shall apply.

Chapter VIII Supplementary Provisions

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