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Premier Li Qiang has signed a State Council decree, promulgating the "Regulations on the Administration of Clinical Research and Translation of Novel Biomedical Technologies." This important regulation was adopted at the State Council executive meeting on September 12, 2025, and will take effect on May 1, 2026. This establishes a comprehensive legal framework for China's oversight of novel biomedical technologies throughout the entire chain from research to application.
Officials from the Ministry of Justice and the National Health Commission of the People's Republic of China took questions from the press on the Regulations.
Q: Could you brief us on the background of formulating these Regulations?
A: Biomedical technology holds great potential for disease prevention, diagnosis, and treatment, and serves as a major driver for medical progress and public health. In recent years, China has prioritized the innovative development of biomedical technology, continuously enhancing policy support and boosting innovation capacity. Concurrently, these technologies evolve rapidly, are highly personalized, involve complex innovation, present significant R&D challenges, and carry substantial risks. It is therefore necessary to balance development with security, fostering high-quality development. The formulation of these Regulations is essential to further improve the management system for the clinical research and translation of novel biomedical technologies, standardize their R&D and application, promote medical progress and innovation, ensure healthcare quality and safety, and uphold human dignity and health.
Q: What is the overall approach in formulating the Regulations?
A: The formulation of the Regulations is guided by the following principles: first, adhering to a people-centered approach to health, with emphasis on risk prevention and control, and safety assurance. Second, supporting clinical research and translation of novel biomedical technologies to foster innovation and development. Third, reinforcing the primary responsibility of institutions, specifying the obligations of clinical research sponsors and research institutions, and ensuring accountability.
Q: What is the scope of the Regulations' application?
A: These Regulations apply to clinical research, translation, and corresponding supervision and management activities concerning novel biomedical technologies conducted within the territory of the People's Republic of China. To encourage innovation and provide guidance for the sector, and based on extensive research and public consultation, the Regulations define "novel biomedical technologies" as new medical technologies that apply biological principles and act at the cellular or molecular level in the human body. The Regulations also stipulate that the health administration department of the State Council, together with the drug regulatory department of the State Council, shall formulate and adjust guiding principles for defining the boundaries between novel biomedical technologies, pharmaceuticals, and medical devices based on scientific and technological developments.
Q: What are the key provisions regarding the regulation of clinical research?
A: Conducting clinical research is crucial for advancing biomedical technology and ensuring its safety and efficacy. To better support the development of novel biomedical technologies and strengthen risk prevention and control, the Regulations stipulate the following provisions for standardizing clinical research:
Defining prerequisites and bottom lines: Clinical research may only proceed after the technology's safety and efficacy have been demonstrated through non-clinical studies, and it has passed academic and ethical reviews. Technologies explicitly prohibited by laws or administrative regulations, or those involving major ethical concerns, are not permitted for clinical research.
Supporting clinical research: A filing system is implemented for clinical research, specifying the conditions for clinical research institutions and detailing the filing procedures. The health administration department of the State Council is required to evaluate filed clinical research projects and take corrective measures, including suspending research, if risks are identified.
Strengthening management of research implementation: Clinical research institutions must conduct research in accordance with the filed protocol, implementing measures to prevent, control, and address risks. Follow-up monitoring of subjects is required after the research concludes to assess the technology's long-term safety and efficacy.
Q: What provisions support clinical translation?
A: Once translated into clinical practice, novel biomedical technologies will be widely applied to patients, making it imperative to ensure their safety, efficacy, and adherence to ethical principles. The Regulations stipulate the following provisions for clinical translation:
Establishing a clear pathway: Addressing the current lack of a defined pathway for clinical translation, the Regulations set out the conditions and procedures. Technologies proven safe and effective through clinical research and compliant with ethical principles can be approved for translation by the health administration department of the State Council, with detailed approval processes and timelines specified.
Ensuring quality and safety in application: When approving a technology for clinical translation, the health administration department of the State Council shall simultaneously publish the required qualifications for medical institutions and healthcare professionals applying the technology, as well as the standard operating procedures for clinical application. Medical institutions and their practitioners must meet these requirements and comply with the operating procedures to ensure healthcare quality and safety.
Providing for ongoing evaluation: Considering the rapid pace of development and evolving understanding of these technologies, the Regulations require the health administration department of the State Council to conduct re-evaluations based on scientific progress. Technologies deemed unable to guarantee safety and effectiveness upon re-evaluation will be prohibited from clinical application.
Q: What specific provisions are in place to protect the rights and interests of subjects?
A: Protecting subjects' rights and interests is a fundamental principle of clinical research. The Regulations contain explicit provisions for the protection of subjects' rights, covering areas such as informed consent, privacy, and mechanisms for damage relief.
Q: What work is required to ensure the smooth implementation of the Regulations?
A: To ensure the Regulations are effectively implemented, the National Health Commission, in conjunction with relevant parties, will focus on the following tasks:
Enhancing publicity and interpretation: Given the highly specialized and technical nature of the Regulations, various forms of publicity, interpretation, training, and guidance will be organized to help relevant research institutions, medical institutions, and others better grasp the legislative intent, significance, and core content of the Regulations.
Strengthening supporting systems: Relevant supporting rules will be formulated or revised in a timely manner. Efforts will be accelerated to develop the guiding principles for defining novel biomedical technologies, pharmaceuticals, and medical devices. Specific issues arising during implementation will be detailed and clarified to ensure the Regulations' provisions are fully implemented.
Improving information systems: A robust online service system for the clinical research and translation of novel biomedical technologies will be established and integrated with the national integrated government service platform. This will provide convenient service support for filing clinical research, applying for administrative permits, reporting information, and other related procedures.
Building personnel capacity: Adequate and qualified personnel necessary for implementing the Regulations will be allocated. Guidance and supervision will be strengthened to enhance regulatory enforcement capabilities and ensure the smooth implementation of the Regulations.
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Premier Li Qiang has signed a State Council decree, promulgating the "Regulations on the Administration of Clinical Research and Translation of Novel Biomedical Technologies." This important regulation was adopted at the State Council executive meeting on September 12, 2025, and will take effect on May 1, 2026. This establishes a comprehensive legal framework for China's oversight of novel biomedical technologies throughout the entire chain from research to application.
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