On September 28, 2025, Premier Li Qiang signed State Council Order No. 818, promulgating the "Regulations on the Management of Clinical Research and Clinical Transformation Application of New Biomedical Technologies" (hereinafter referred to as the "Regulations"), which will come into effect on May 1, 2026. Recently, the heads of the Ministry of Justice and the National Health Commission answered reporters’ questions on issues related to the Regulations.
Q: Please briefly introduce the background of the promulgation of the Regulations.
Answer: Biomedical technology has shown great potential in disease prevention, diagnosis, treatment and other fields, and is an important driving force for medical progress and health development. In recent years, our country has attached great importance to the innovative development of biomedical technology, continued to increase policy support, and continuously improved its innovation capabilities. At the same time, biomedical technology iterates quickly, has strong personalization, and a high degree of innovation. New technology research and development is difficult and involves many risks. It is necessary to adhere to innovation-led development while coordinating development and safety to promote high-quality development. In order to further improve the management system for clinical research and clinical transformation application of new biomedical technologies, standardize the research and development and application of new biomedical technologies, promote medical progress and innovation, ensure medical quality and safety, and safeguard human dignity and health, it is necessary to formulate the Regulations.
Question: What is the overall idea behind formulating the Regulations?
Answer: The formulation of the "Regulations" follows the following general ideas: First, adhere to people's health as the center, focus on risk prevention and control, and ensure safety. The second is to support clinical research and clinical translation applications of new biomedical technologies and promote innovative development. The third is to consolidate the responsibilities of institutional entities, clarify the obligations of clinical research initiating institutions and clinical research institutions, and strengthen the implementation of responsibilities.
Q: What is the scope of application of the Regulations?
Answer: When engaging in clinical research, clinical transformation and application of new biomedical technologies and their supervision and management within the territory of my country, the provisions of the Regulations shall apply. In order to encourage innovation and provide guidance for industry development, based on extensive research and listening to opinions, the Regulations define new biomedical technologies as new medical technologies that use biological principles to act on human cells and molecular levels. It also stipulates that the health department of the State Council, together with the drug regulatory department of the State Council, will formulate and adjust the guiding principles for the definition of new biomedical technologies, drugs, and medical devices based on the development of science and technology.
Q: What provisions do the Regulations provide in regulating clinical research?
Answer: Conducting clinical research plays an important role in promoting biomedical technology innovation and ensuring that technology is safe and effective. In order to better support the development of new biomedical technologies and strengthen risk prevention and control, the Regulations stipulate the standardization of clinical research in the following aspects. The first is to clarify the prerequisites and red lines of clinical research. It is stipulated that new biomedical technologies that have been proven safe and effective by non-clinical research and have passed academic and ethical review can be used for clinical research; new biomedical technologies that are expressly prohibited by laws, administrative regulations, etc. and that have major ethical issues are not allowed to be used for clinical research. The second is to support the development of clinical research, implement registration management of clinical research, clarify the conditions of clinical research institutions, and refine the registration procedures; require the health department of the State Council to evaluate registered clinical research, and promptly correct risks until they are stopped. The third is to strengthen clinical research implementation management. It is stipulated that clinical research institutions should implement clinical research in accordance with the registered research plan and take measures to prevent, control and deal with risks; after the clinical research is completed, the subjects should be followed up and monitored to evaluate the long-term safety and effectiveness of the technology.
Q: What provisions do the Regulations make in supporting clinical translation applications?
Answer: New biomedical technologies will be widely used on patients after their clinical transformation and application. It is necessary to ensure that the technology is safe, effective, and consistent with ethical principles. The Regulations stipulate clinical translation applications from the following aspects. First, in view of the current lack of clear paths for clinical transformation and application of new biomedical technologies, the conditions and procedures for clinical transformation and application are stipulated. New biomedical technologies that have been proven safe and effective by clinical studies and comply with ethical principles can be transformed and applied with the approval of the health department of the State Council; the approval process will be refined and the approval time limit will be clarified. The second is to ensure the quality and safety of clinical applications. When the health department of the State Council approves the clinical transformation and application of new biomedical technologies, it is required to publish the conditions that medical institutions and professional technicians who apply the technology should have and the clinical application operating procedures; medical institutions and their medical personnel should meet the prescribed conditions, abide by the clinical application operating procedures, and ensure the quality and safety of medical care. Third, considering the rapid development of new biomedical technologies and the deepening of understanding of them, the Regulations require the health department of the State Council to re-evaluate new biomedical technologies for clinical translation and application based on the development of scientific research. If the new technologies cannot be guaranteed to be safe and effective after evaluation, clinical application is prohibited.
Q: What provisions do the Regulations provide in protecting the legitimate rights and interests of subjects?
Answer: Protecting the legitimate rights and interests of subjects is a basic principle for conducting clinical research. The Regulations clearly stipulate the protection of the rights and interests of subjects. First, the basic requirements for protecting the legitimate rights and interests of subjects are clarified in the general principles. The second is to stipulate that to implement clinical research, written informed consent must be obtained from the subjects or their guardians; if changes to the clinical research plan may have an impact on the rights and interests of the subjects, informed consent needs to be obtained again. The third is to stipulate that clinical research-related fees shall not be charged to subjects when conducting clinical research. Fourth, it is stipulated that if clinical research causes health damage to subjects, clinical research institutions should provide timely treatment; clinical research sponsors and clinical research institutions are encouraged to purchase commercial insurance to provide more protection for subjects. Fifth, relevant institutions are required to protect the personal privacy and personal information of subjects in accordance with the law.
Question: What needs to be done to ensure the smooth implementation of the Regulations?
Answer: In order to ensure the implementation of the Regulations, the National Health Commission will work with relevant parties to focus on the following work. The first is to increase publicity and interpretation. The "Regulations" are highly professional and technical. The next step will be to organize various forms of publicity, interpretation and training guidance to help relevant scientific research institutions, medical institutions, etc. better understand the legislative purpose, significance, and core content of the "Regulations." The second is to strengthen the construction of supporting systems. Timely formulate and revise relevant supporting regulations, speed up the formulation of guiding principles for the definition of new biomedical technologies, drugs, and medical devices, refine and clarify specific issues in the implementation of the Regulations, and ensure the implementation of the regulations. The third is to strengthen the construction of information systems. Establish and improve the online service system for clinical research and clinical transformation application of new biomedical technologies, and connect with the national integrated government service platform to provide convenient service support for clinical research filing, application for administrative licenses, reporting information, etc. The fourth is to strengthen the construction of relevant personnel teams. Allocate and strengthen the personnel required for the implementation of the "Regulations", strengthen guidance and supervision, improve the ability and level of regulatory enforcement, and ensure the smooth implementation of the "Regulations".
