The China State Council released the “Administrative Regulation on Clinical Research and Clinical Transformation of New Biomedical Technologies” on October 10, 2025, which will be effective on May 1, 2026. This landmark regulation was signed by China Premier Li Qiang. It establishes a unified, stringent management framework for all activities involving cutting-edge biomedical technologies within China. Importantly, it applies to all projects conducted “within the territory of China,” including those operated by foreign-invested institutions.
China Med Device, LLC, as a legal representative in China, can assist companies in establishing domestic sponsor entities in pilot zones, identifying qualified hospitals, navigating ethics reviews, and preparing compliant documents such as non-clinical reports which is required before initiation of the trials. Email info@ChinaMedDevice.com for more information.
Key Takeaways for the Sponsor
China Med Device, LLC notifies the sponsors that the following key points shall be given special attentions:
- The regulation defines “new biomedical technologies” as medical methods and measures that operate at the cellular or molecular level and have not yet been clinically applied in China. This definition clearly covers stem cells, induced pluripotent stem cells (iPSCs), CAR-T and TCR-T therapies, gene editing technologies such as CRISPR, and in vivo gene therapy platforms. Any project involving these technologies must follow the full regulatory process before entering clinical practice.
- To initiate a biomedical new technology project, the sponsor must be a legal entity registered in China. Consequently, foreign companies wishing to conduct clinical research in China must first establish a domestic subsidiary or other eligible legal entity. Sponsors must also comply with negative lists and confirm whether their proposed projects fall within designated pilot regions and approved technical fields.
- Implementation is restricted to a narrow set of qualified medical institutions. Only Class-A tertiary hospitals that possess an independent scientific review committee, an ethics committee, and complete internal management systems may conduct such clinical studies. Because the number of hospitals that meet all criteria is limited, securing partnerships is expected to be challenging.
- Project leadership requirements are equally strict. The principal investigator must hold a Chinese medical practitioner license, possess a senior professional title, and have the implementing institution as their primary practice site. Administrative leaders or nominal project heads who lack medical qualifications will be easily identified during regulatory inspections.
- Sponsors must submit nine categories of documentation in one package. False or misleading materials may incur criminal liability. Among these, non-clinical research reports, risk management plans, and informed consent templates are the most prone to error. For clinical translation applications, six categories of core materials—including clinical research reports, risk analyses, and standardized operating procedures—must be submitted. The quality and completeness of these materials directly affect the approval outcome.
- Projects intended for the treatment of life-threatening conditions with no effective existing treatment may apply for priority review, shortening overall evaluation timelines.
Scope and Requirements for Clinical Research
The regulation clarifies the types of activities that constitute clinical research on new biomedical technologies. These include:
- Direct operations performed on the human body.
- Manipulation of ex vivo human cells, tissues, or organs that are subsequently implanted or infused into humans.
- Manipulation of human reproductive cells, zygotes, or embryos prior to implantation.
- Other activities specified by national health authorities.
Before initiating a clinical study, sponsors must complete laboratory research, animal experiments, and other non-clinical studies. Only when non-clinical evidence demonstrates safety and potential effectiveness may the clinical phase begin.
Once the academic and ethics reviews are completed, the implementing institution must file the study with the National Health Commission (NHC) within five working days. If the study involves multiple clinical sites, the lead site designated by the sponsor will complete the filing process.
Clinical Study Conduct and Compliance Obligations
Clinical institutions must follow the approved research protocol and obtain written informed consent from all participants. Sponsors and investigators are prohibited from charging participants any research-related fees.
Institutions must maintain accurate, timely, and complete research records and preserve original materials for 30 years after study completion; if offspring are involved, records must be stored permanently. Falsification, alteration, or concealment of research data is strictly forbidden.
If technical support, biological samples, or participant recruitment services are outsourced to other institutions, the implementing site must disclose the study’s purpose, protocol, filing status, and sample usage. Clinical sites are also required to submit regular progress reports to the NHC.
Clinical Transformation and Approval for Medical Use
Upon completion of clinical research, any plan to transition the technology to clinical application must undergo NHC review and approval. Within five working days of receiving an application, the NHC will forward materials to specialized agencies for technical and ethical assessments. Following receipt of evaluation results, a final decision must be issued within fifteen working days. Only technologies proven to be safe, effective, and ethically compliant will be approved.
For technologies addressing critical, life-threatening conditions without existing effective therapies, as well as those urgently needed for public health, priority review pathways may be used.
Once a technology is approved for clinical use, medical institutions must meet NHC-specified conditions and comply with standardized operating procedures. Fees may be charged according to relevant regulations.