Q&A with Officials from the Ministry of Justice and National Health Commission on the Regulation on Clinical Research and Translational Application of Biomedical New Technologies

On October 10, 2025, the “Regulations on the Clinical Research and Clinical Translation Application of New Biomedical Technologies” (hereinafter referred to as the “Regulations”) were promulgated and will come into force on May 1, 2026. Recently, officials from the Ministry of Justice and the National Health Commission answered reporters’ questions regarding the Regulations.

Source: Official Website of the Ministry of Justice

Q: Please provide a brief overview of the background behind the promulgation of the Regulations.

Answer:Biomedical technologies have demonstrated immense potential in disease prevention, diagnosis, and treatment, serving as a key driver for medical advancement and the development of health services. In recent years, China has attached great importance to the innovative development of biomedical technologies, continuously strengthened policy support, and steadily enhanced its innovation capabilities. Meanwhile, given the rapid iteration, strong personalization attributes, and high degree of innovation inherent in biomedical technologies—as well as the significant challenges and risks associated with the research and development of new technologies—it is essential to balance development and safety while adhering to innovation-led growth, thereby promoting high-quality development. To further improve the regulatory framework for clinical research and translational application of new biomedical technologies, standardize their research, development, and application, foster medical progress and innovation, ensure the quality and safety of medical care, and safeguard human dignity and health, it is necessary to enact the Regulations.

Q: What is the overall rationale for formulating the Regulations?

Answer:The formulation of the Regulations adheres to the following overarching principles: First, uphold a people-centered approach to health, with an emphasis on risk prevention and control and safety assurance. Second, support clinical research and the translational application of novel biomedical technologies to foster innovative development. Third, consolidate the primary responsibilities of institutions by clarifying the obligations of sponsors and conducting institutions of clinical research, thereby strengthening accountability.

Q: What is the scope of application of the Regulations?

Answer:The Regulations apply to clinical research, clinical translational application, and the supervision and administration of new biomedical technologies within the territory of China. To encourage innovation and provide guidance for industry development, and on the basis of extensive research and consultation, the Regulations define new biomedical technologies as novel medical technologies that apply biological principles at the cellular and molecular levels of the human body. The Regulations further stipulate that the health administrative department of the State Council, in conjunction with the drug regulatory department of the State Council, shall formulate and adjust guiding principles for delineating the boundaries between new biomedical technologies, drugs, and medical devices, in light of scientific and technological advancements.

Q: What provisions does the Regulations make for regulating clinical research?

A:Conducting clinical research plays a vital role in promoting innovation in biomedical technologies and ensuring their safety and efficacy. To better support the development of new biomedical technologies and strengthen risk prevention and control, the Regulations set forth provisions to standardize clinical research from the following aspects. First, it clarifies the prerequisites and red lines for clinical research. It stipulates that clinical research may only be conducted after new biomedical technologies have been proven safe and effective through non-clinical studies and have passed academic and ethical reviews. Clinical research is prohibited for new biomedical technologies that are expressly forbidden by laws and administrative regulations or that involve significant ethical issues. Second, it supports the conduct of clinical research by implementing a filing-based management system, specifying the qualifications for clinical research institutions, and detailing the filing procedures. It requires the health department of the State Council to assess filed clinical research projects and to take timely corrective actions, up to and including suspension, upon identification of risks. Third, it strengthens the management of clinical research implementation. It mandates that clinical research institutions conduct clinical research in accordance with the filed research protocols and take measures to prevent, control, and address risks. Furthermore, follow-up monitoring of participants shall be conducted after the completion of clinical research to evaluate the long-term safety and efficacy of the technologies.

Q: What provisions does the Regulation include to support clinical translation and application?

A:Following the clinical translational application of new biomedical technologies, which will be widely used in patients, it is essential to ensure that these technologies are safe, effective, and compliant with ethical principles. The Regulations stipulate provisions for clinical translational application from the following aspects. First, addressing the current lack of a clear pathway for the clinical translational application of new biomedical technologies, the Regulations specify the conditions and procedures for such applications. New biomedical technologies that have been proven safe and effective through clinical research and comply with ethical principles may be translated into clinical application upon approval by the health administrative department of the State Council; the approval process is refined, and approval timeframes are clarified. Second, ensuring the quality and safety of clinical applications. The Regulations require that when the health administrative department of the State Council approves the clinical translational application of new biomedical technologies, it shall simultaneously publish the conditions that medical institutions and professional technical personnel must meet to apply such technologies, as well as the operational norms for clinical application. Medical institutions and their medical personnel must meet the prescribed conditions and adhere to the operational norms for clinical application to safeguard the quality and safety of medical care. Third, considering the rapid development of new biomedical technologies and the deepening understanding thereof, the Regulations require the health administrative department of the State Council to conduct re-evaluations of new biomedical technologies under clinical translational application based on scientific research advancements, among other factors. If an evaluation determines that safety and efficacy cannot be guaranteed, clinical application shall be prohibited.

Q: What provisions does the Regulations make to protect the legitimate rights and interests of human subjects?

Answer:Protecting the legitimate rights and interests of research subjects is a fundamental principle in conducting clinical research, and the Regulations provide explicit provisions on such protection. First, the General Provisions set forth the basic requirements for safeguarding the legitimate rights and interests of research subjects. Second, it stipulates that written informed consent must be obtained from the research subject or their legal guardian before initiating clinical research; if amendments to the clinical research protocol may affect the rights and interests of research subjects, informed consent must be re-obtained. Third, it prohibits charging research subjects any fees related to the clinical research. Fourth, it requires that clinical research institutions provide timely treatment for any health harm caused to research subjects by the clinical research, and encourages sponsors and clinical research institutions to purchase commercial insurance to provide additional protections for research subjects. Fifth, it mandates that relevant institutions protect the personal privacy and personal information of research subjects in accordance with the law.

Q: What measures need to be taken to ensure the smooth implementation of the Regulations?

Answer:To ensure the effective implementation of the Regulations, the National Health Commission will collaborate with relevant stakeholders to prioritize the following initiatives. First, intensify publicity and interpretation efforts. Given the highly specialized and technical nature of the Regulations, various forms of publicity, interpretation, and training guidance will be organized to help research institutions, medical facilities, and other relevant entities better understand the legislative intent, significant importance, and core content of the Regulations. Second, strengthen the development of supporting institutional frameworks. Relevant supporting provisions will be formulated or revised in a timely manner, and guiding principles for delineating novel biomedical technologies from pharmaceuticals and medical devices will be expedited. This aims to clarify and specify concrete issues arising during the implementation of the Regulations, ensuring that their provisions are thoroughly and meticulously enforced. Third, enhance information system infrastructure. A comprehensive online service system for clinical research and clinical translational applications of novel biomedical technologies will be established and improved, ensuring seamless integration with the National Integrated Government Service Platform. This will provide convenient service support for activities such as clinical research filing, administrative licensing applications, and information reporting. Fourth, strengthen workforce development. Adequate and highly competent personnel will be allocated to support the implementation of the Regulations. Guidance and supervision will be reinforced to enhance regulatory enforcement capabilities and standards, thereby ensuring the smooth implementation of the Regulations.