The Regulations on the Administration of Clinical Research and Clinical Transformation Application of Biomedical New Technologies (hereinafter referred to as the Regulations) shall come into force and be implemented on May 1, 2026. To standardize the clinical research and clinical transformation application of biomedical new technologies, promote the progress of medical science and technology, and ensure medical quality and safety, the relevant matters are hereby announced as follows:

I. Reasonable Selection of Technical Path or Pharmaceutical and Medical Device Path

By establishing a new path for the clinical research and clinical transformation application of biomedical new technologies, the Regulations complement and coordinate with the Pharmaceutical Administration Law of the People's Republic of China and the Regulations on the Supervision and Administration of Medical Devices, jointly forming a management system covering the entire innovation chain of biomedicine. The National Health Commission, together with the National Medical Products Administration, has formulated and issued the Guiding Principles for the Definition of Biomedical New Technologies, Pharmaceuticals and Medical Devices (hereinafter referred to as the Definition Guiding Principles).

Initiating institutions of clinical research (hereinafter referred to as Initiating Institutions) shall refer to the Definition Guiding Principles and select the appropriate technical path or pharmaceutical and medical device path in a scientific and reasonable manner based on their actual conditions. Those choosing the biomedical new technology path shall carry out clinical research in accordance with the provisions of the Regulations, and may apply for clinical transformation application if complying with the specified scope upon completion of clinical research; data generated from clinical research may be used to support the clinical transformation application of biomedical new technologies. Those choosing the pharmaceutical and medical device path shall conduct relevant work in accordance with the provisions on the administration of pharmaceuticals and medical devices. Initiating Institutions shall fully consider the respective characteristics of the two paths and avoid duplication of work.

II. Improve the Quality and Efficiency of Clinical Research Filing and Clinical Transformation Application Approval

When conducting clinical research filing or applying for clinical transformation application of biomedical new technologies, Initiating Institutions and clinical research institutions (hereinafter

 referred to as Research Institutions) shall submit filing or application materials in accordance with the requirements of documents such as the Guidelines for Clinical Research Filing and the Specifications for Clinical Transformation Application Approval, and ensure the authenticity, accuracy and completeness of the submitted materials.

Applications and filings for clinical research and clinical transformation application shall be submitted through the online service system for clinical research and clinical transformation application of biomedical new technologies (National Medical Research Registration and Filing Information System: https://www.medicalresearch.org.cn). Please refer to the system operation manual for specific operation guidelines.

China National Center for Biotechnology Development shall be responsible for verifying and confirming clinical research filing materials and evaluating filed clinical research projects. Together with the Medical Management Service Guidance Center of the National Health Commission, it shall undertake technical assessment and ethical evaluation for clinical transformation application approval, and accept work suggestions put forward by Initiating Institutions and Research Institutions.

III. Standardize the Organization and Implementation of Clinical Research

Clinical research on biomedical new technologies involves multiple links. Initiating Institutions and Research Institutions shall establish a collaborative mechanism with clear rights and responsibilities and efficient communication to effectively perform their respective duties. Initiating Institutions shall cooperate with Research Institutions to provide test articles for new technologies and guarantee their quality and safety.

Research Institutions shall ensure the implementation of clinical research in accordance with the filed protocols, attach importance to process management, risk monitoring and disposal, data recording and preservation, and adverse event reporting, and ensure stable and sufficient funding sources. For multi-center clinical research, the leading research institution shall strengthen coordination among multiple centers, and each center shall strictly implement its assigned research content in accordance with the research protocol.

Initiating Institutions and Research Institutions shall strengthen conflict of interest management, establish a conflict of interest review mechanism, and properly manage conflicts of interest through recusal systems, information disclosure and other means.

IV. Strengthen the Protection of Subjects' Rights and Interests

Initiating Institutions and Research Institutions shall take the initiative to safeguard subjects' rights and interests including life and health, informed consent, and privacy protection. When conducting ethical review of clinical research, Research Institutions shall, in addition to complying with general ethical requirements for clinical research, conduct review in accordance with the Guidelines for Clinical Research Filing and the characteristics and special ethical requirements of the proposed biomedical new technologies.

In the process of research implementation, full consideration shall be given to medical equity; subject recruitment and enrollment shall be carried out in accordance with the inclusion and exclusion criteria specified in the research protocol to steadily advance the research and timely control and dispose of potential risks in the implementation process. No fees related to clinical research shall be charged to subjects.

In case of health damage caused to subjects during clinical research, Research Institutions shall give top priority to the life and health of subjects, conduct timely assessment and provide treatment; the treatment expenses shall be borne accordingly in accordance with Article 27 of the Regulations. Initiating Institutions and Research Institutions are encouraged to provide protection for subjects through various means such as purchasing commercial insurance.

V. Promote the Clinical Transformation Application in a Prudent and Steady Manner

Adhering to the principle of clinical necessity, prudence and orderly progress, clinical transformation application approval shall be carried out for biomedical new technologies that are difficult to be developed into medical devices, as well as innovative and highly personalized biomedical new technologies that have not yet or are difficult to be developed into pharmaceuticals. Priority shall be given to the review and approval of biomedical new technologies for treating life-threatening diseases with no effective treatment options and those urgently needed for public health purposes.

Under emergency circumstances, upon demonstration and confirmation of necessity by the National Health Commission, biomedical new technologies under research may be used emergently within a certain scope and time limit. China National Center for Biotechnology Development shall establish and improve a daily communication mechanism with Initiating Institutions and Research Institutions to provide necessary consultation and guidance. Initiating Institutions and Research Institutions shall communicate with China National Center for Biotechnology Development when conducting confirmatory clinical research for the purpose of clinical transformation application.

VI. Severely Punish Data Fraud

The quality of clinical research data is the core foundation supporting the clinical transformation application of biomedical new technologies. Initiating Institutions and Research Institutions shall attach great importance to the quality of research data and ensure the authenticity, integrity and traceability of clinical research results and data.

Health administrative departments at or above the county level shall strengthen the supervision and administration of clinical research and clinical transformation application of biomedical new technologies, strengthen the management and guidance of Initiating Institutions and Research Institutions together with relevant departments, and promptly investigate, punish and circulate notices on irregularities in the clinical research process.

If false materials or data fraud are found in the filing of clinical research or the approval of clinical transformation application of biomedical new technologies, severe penalties shall be imposed in accordance with the relevant provisions of the Regulations, and the case shall be publicly notified. Those constituting crimes shall be held criminally responsible in accordance with laws and regulations.

Hereby Announced.

National Health CommissionNational Administration of Disease Control and Prevention

April 30, 2026

Q&A Interpretation of the Regulations on the Administration of Clinical Research and Clinical Transformation Application of Biomedical New Technologies

The Regulations on the Administration of Clinical Research and Clinical Transformation Application of Biomedical New Technologies (hereinafter referred to as the Regulations) shall be officially implemented on May 1, 2026. To ensure the effective implementation of the Regulations, the National Health Commission has formulated and issued relevant supporting documents. Recently, officials from the Department of Science, Technology and Education of the National Health Commission answered media questions on issues of public concern.

1. What is the relationship between the Regulations and the Pharmaceutical Administration Law of the People's Republic of China as well as the Regulations on the Supervision and Administration of Medical Devices? What role will the Regulations play?

Answer: The Regulations are complementary and coordinated with the Pharmaceutical Administration Law of the People's Republic of China and the Regulations on the Supervision and Administration of Medical Devices, jointly forming a management system covering the entire innovation chain of biomedicine. In terms of core objectives, all adhere to the fundamental principles of safeguarding safety, encouraging research and development, and meeting clinical needs, jointly controlling risk red lines and protecting people’s life and health.

The implementation of the Regulations will further standardize the conduct of clinical research activities, improve the capacity and level of clinical research, systematically accumulate high-quality clinical research data, unblock the path of clinical transformation, help build a more diversified and dynamic industry innovation ecosystem, and better boost industrial development and improve people’s health.

2. How to define biomedical new technologies, pharmaceuticals and medical devices as specified in the Regulations?

Answer: The definition of biomedical new technologies under the Regulations adheres to balancing development and safety, orientates toward meeting people’s health needs, fully considers the characteristics of different development stages, and focuses on policy connection and coordination among competent authorities.

At the clinical research stage, initiating institutions of clinical research shall independently define the attributes of new technologies to be carried out with reference to the Guidance List for the Filing of Clinical Research on Biomedical New Technologies.

At the clinical transformation application stage, only technologies included in the Guidance List and meeting one of the following requirements shall be included in the scope of approval:First, technologies with a high degree of personalization, for which no domestically marketed drugs adopting the same mechanism and principle have been approved for listing or confirmatory clinical trials have been launched;Second, technologies for the treatment of rare diseases, for which no domestically marketed drugs adopting the same mechanism and principle for the same indications have been approved for listing or confirmatory clinical trials have been launched.

It is clearly stipulated that technologies conforming to the definition under the Regulations on the Supervision and Administration of Medical Devices shall go through registration procedures in accordance with medical device regulations and shall not be included in the approval scope for clinical transformation application of biomedical new technologies.

3. What are the considerations for adopting the "list-based" management model for biomedical new technologies?

Answer: The adoption of "list-based" management for biomedical new technologies, namely formulating and dynamically adjusting the Guidance List for the Filing of Clinical Research on Biomedical New Technologies, is mainly based on the following considerations:

First, in the early stage such as clinical research, biomedical new technologies feature rapid iteration and numerous influencing factors, and there is great uncertainty over whether they will be transformed into pharmaceuticals, medical devices or medical technologies in the future. Following the principle of inclusiveness and prudence, list-based management provides clear technical definition references for clinical research initiating institutions, guiding them to independently define the attributes of new technologies to be studied, and improving the efficiency and quality of filing.

Second, list-based management embodies the general idea of balancing development and safety, which not only supports the innovative development of biomedical new technologies, but also upholds the bottom line of safety and ethics through clear inclusion principles.

Third, the health authority of the State Council will dynamically adjust the list according to technological development and changes in clinical demand, and establish mechanisms for inclusion, deletion and removal after demonstration. It can timely incorporate eligible new technologies, and remove technologies in a timely manner in case of major ethical issues, doubtful safety and effectiveness, or the launch of similar pharmaceuticals and medical devices or approval of clinical transformation application as medical technologies, ensuring the forward-looking and flexibility of management.

Fourth, this model facilitates dislocation development with the pharmaceutical and medical device management systems, guides R&D resources toward directions with genuine technological innovation value and clinical demand, and avoids duplicate research.

4. How should clinical research institutions complete filing in accordance with the requirements of the Regulations?

Answer: A series of supporting filing guidelines have been issued alongside the Regulations, providing general technical guidance for clinical research filing to ensure the scientificity, safety and ethical compliance of clinical research.

The filing guidelines specify detailed technical requirements for key links such as preparation and quality control of test articles for various technologies, non-clinical research, design and implementation of clinical research protocols, and ethical compliance. They guide researchers to conduct research in a scientific and standardized manner, protect the rights and interests of research subjects, and promote technological progress and innovation.

In addition to the materials explicitly required under Article 16 of the Regulations for clinical research filing, applicants shall also submit reports on the preparation and quality control of test articles, relevant documents of authorized quality personnel, etc.

Clinical research institutions shall submit materials via the online service system for clinical research and clinical transformation application of biomedical new technologies (National Medical Research Registration and Filing Information System), and shall be responsible for the authenticity, accuracy and completeness of the submitted materials.

5. What requirements does the Regulations set for the data quality of clinical research?

Answer: The quality of clinical research data is the core foundation supporting the clinical transformation and application of technologies. Initiating institutions and clinical research institutions must ensure the authenticity, integrity and traceability of clinical research results and data. They shall establish a sound system for data recording, preservation and management, earnestly fulfill primary responsibilities, and strictly prohibit data fraud.

In the process of clinical research filing or clinical transformation application approval, any act of submitting false materials or data fraud shall be severely punished in accordance with relevant provisions of the Regulations and publicly notified. Those committing crimes shall be held criminally responsible in accordance with laws and regulations.

6. What provisions does the Regulations make on the scope of approval for clinical transformation application?

Answer: The approval scope for clinical transformation application of biomedical new technologies focuses on highly personalized new technologies and new technologies for the treatment of rare diseases, mainly based on the following considerations:

First, orienting toward meeting people’s health needs. In clinical practice, the high R&D cost and long cycle of traditional drugs, as well as market failure in the field of rare diseases, leave patients without effective treatment options. The development of biomedical new technologies provides new treatment alternatives for such patients, and focusing on these fields helps explore new treatment directions for diseases with no effective therapies.

Second, realizing dislocation development and functional complementarity with the pharmaceutical management system. For technologies with high personalization that are difficult to be developed into standardized drugs, and technologies targeting rare diseases hindered by market failure, the technical transformation path can accelerate the progression of new technologies from conceptual research to clinical application. Focusing on the above two aspects avoids duplication with the existing drug approval system, accurately responds to special fields with urgent clinical needs and market failure, and embodies the principle of clinical necessity, prudence and orderly progress.

7. Why is ethical evaluation emphasized in the review of clinical transformation application?

Answer: The emphasis on ethical evaluation in the review of clinical transformation application of biomedical new technologies is determined by the inherent particularity and risks of such technologies. Biomedical new technologies are often accompanied by significant technical and ethical risks and may easily arouse social doubts. Therefore, it must be ensured that the application of technologies shall not harm human health, violate ethical principles, or damage public interests and national security.

Ethical evaluation focuses on reviewing ethical compliance of technologies, protection of patients' rights and interests, social ethics and public security. Ethical evaluation is equally important as technical evaluation and indispensable to each other: technical evaluation mainly answers whether a technology can be used, while ethical evaluation focuses on judging whether it should be used.

Only after confirming that the technology bears no major ethical risks and can fully protect patients' rights and interests through ethical evaluation can it enter the subsequent approval procedures. This fully reflects the principles of the Regulations: putting people's health first, adhering to innovation-driven development, balancing development and safety, and ensuring that clinical transformation application shall not harm human health.

8. What are the considerations for implementing risk classification in the clinical transformation application of biomedical new technologies?

Answer: The implementation of risk classification management for the clinical transformation application of biomedical new technologies is mainly based on the following considerations:

First, biomedical new technologies generally take a short time from invention to clinical research with relatively insufficient maturity, and some potential and unknown safety risks may not be fully exposed in limited research processes.

Second, restricted by the current level of scientific and technological development and cognitive limitations, some technologies may have unforeseen long-term risks.

Therefore, it is necessary to classify risk levels according to technical characteristics and implement differentiated supervision. By restricting the scope of use within a certain period after approval and requiring long-term follow-up, more real-world evidence can be collected to dynamically control the risks of technology application and better protect public health and safety.

9. How to manage biomedical new technologies after obtaining approval for clinical transformation application under the Regulations?

Answer: After obtaining approval, the clinical application of biomedical new technologies shall comply with strict management requirements:

1. 

The whole process involving biological sample collection, preparation, quality control, preservation and implementation shall be carried out in medical institutions by professional health technicians.

2. 

3. 

Time limits shall be set according to risk levels: 5 years for high-risk technologies, 3 years for medium-risk ones, and 1 year for low-risk ones. During the period, the technologies are only allowed to be applied in qualified medical institutions participating in the clinical research. Upon expiration, if no specific circumstances occur or re-evaluation confirms that benefits outweigh risks, the application scope can be expanded to other qualified institutions and filed as restricted medical technologies.

4. 

5. 

Medical institutions bear the primary responsibility for clinical application management, shall establish a full-process management system, strengthen quality control, and implement authority management for medical personnel to ensure they meet specified qualifications.

6. 

7. 

The informed consent right of patients or their guardians must be guaranteed with signed informed consent forms.

8. 

9. 

Medical institutions shall formulate risk prevention and control measures and emergency response plans.

10. 

11. 

Medical institutions shall report the application situation case by case to provincial health authorities via information systems. In case of serious adverse reactions or medical disputes, medical institutions shall handle them in accordance with regulations and report to provincial health authorities immediately via information systems.

12. 

13. 

In case of major changes in scientific understanding, occurrence of serious adverse reactions or uncontrollable risks, or major social stability risks, the National Health Commission will initiate re-evaluation and suspend application. Technologies confirmed unsafe and ineffective upon evaluation shall be banned from clinical application and publicly announced.

14. 

Seize the Opportunity of the Regulation Implementation to Advance High-quality Clinical Research and Clinical Transformation Application of New Biomedical Technologies

Shen Jianzhong

China National Center for Biotechnology Development

The Regulations on the Administration of Clinical Research and Clinical Application of New Biomedical Technologies (hereinafter referred to as the Regulations) will come into force on May 1 this year. It marks an important milestone in the legalization, standardization and systematization of the administration of new biomedical technology research in China, and provides clear institutional guidelines and broad space for the innovative development of biomedical technologies.

Initiating institutions of clinical research should fulfill their principal responsibilities, fully understand the policy connotation, conduct active innovation, standardized research and efficient transformation on the premise of strictly keeping the bottom line of safety, and help new biomedical technologies benefit patients faster and better.

I. Grasp the Institutional Connotation and Build a New Pattern of Coordinated and Complementary Development

Centering on people’s health and attaching equal importance to innovation-driven development as well as developmental safety, the Regulations and supporting policies fill the regulatory gap in the clinical research and clinical transformation application of new biomedical technologies in China. Meanwhile, the Regulations coordinate organically with the national administration system for pharmaceuticals and medical devices, forming a complete governance framework covering all fields and categories of medical innovation.

It not only opens up a standardized development channel for cutting-edge technologies such as gene technology, cell therapy and regenerative medicine, but also guides the rational allocation of innovation resources by clearly defining the boundary between new technologies, pharmaceuticals and medical devices, effectively avoiding disordered R&D, duplicated investment and low-level homogeneous competition.

The Regulations adopt filing administration for clinical research and approval-based access administration for clinical transformation application. This regulatory model of easy access and strict exit fully embodies institutional inclusiveness and innovation: appropriately simplifying filing procedures at the clinical research stage of new biomedical technologies to unleash innovation vitality; and enforcing strict access criteria at the clinical transformation application stage to guard the safety threshold.

This institutional arrangement extends, improves and strengthens the existing regulatory system, and provides strong support for China to seize the international leading edge in biomedical technological innovation.

II. Fulfill Primary Responsibilities and Promote High-quality Development through Standardized Innovation

Combined with the characteristics and advantages of new technologies, types of clinical indications and application prospects, initiating institutions of clinical research shall carefully evaluate and select either the new technology pathway or the pharmaceutical and medical device pathway to realize dislocation development and diversified transformation. They shall attach importance to collaboration with clinical research institutions, jointly design scientific, rigorous and high-quality research protocols, standardize implementation procedures, and enhance innovation capacity and feasibility.

Initiating institutions and clinical research institutions shall focus on clinical needs, prioritize original innovation, accurately identify indications and innovate research methods, instead of simply copying or blindly following foreign models. They shall actively explore breakthroughs in technical design, research methods and evaluation systems, and strive to form innovative achievements with independent intellectual property rights and international leading standards.

Efforts shall be made to strengthen digital and information-based capacity building, establish and improve a full-process management system, and actively adopt artificial intelligence to realize full-process traceability, tracking and verification, so as to support standardization through digitalization and ensure compliance through informatization.

Institutions shall strengthen awareness of compliance and accountability, strictly abide by laws and regulations, take the initiative to cooperate in filing, verification, evaluation and inspection, innovate quality management models, formulate quality control system standards as well as internal compliance management and risk prevention and control mechanisms, and voluntarily accept industrial regulation and social supervision, so as to safeguard safety through compliance and boost innovation through standardization.

III. Uphold the Safety Bottom Line and Implement Full-cycle High-standard Quality Management Strictly

Safety is the core and foundation of the implementation of the Regulations. The institutional design imposes full-chain primary responsibilities on initiating institutions with stricter requirements, and integrates safety and effectiveness into the whole process of clinical research.

Conducting non-clinical research in a scientific and standardized manner, completing systematic evaluations of pharmacology, toxicology, pharmacokinetics and safety, and verifying the safety and effectiveness of new biomedical technologies with authentic, rigorous and sufficient data to provide solid and reliable scientific basis for clinical research, are essential prerequisites for successful clinical research.

Initiating institutions must regard safety as an insurmountable red line and bottom line, and always take the authenticity and reliability of research data and the controllability of test article quality as rigid norms. Full life cycle quality control shall be strictly implemented; quality objectives, risk control and key quality attributes shall be embedded into the whole R&D process at the research and design stage.

In line with relevant requirements of supporting documents of the Regulations, standardized management shall be implemented for site facilities, personnel qualifications, preparation procedures and quality inspection, and a full-process quality control and traceability system shall be established.

The implementation of the Regulations has pointed out the direction, smoothed the path and provided solid guarantee for the clinical research and clinical transformation application of new biomedical technologies. Initiating institutions and clinical research institutions shall keep in mind the original mission of putting people’s health first, uphold the safety bottom line, fulfill primary responsibilities, standardize research behaviors, promote original innovation, and contribute to the high-quality development of China’s health care sector.

Firmly Uphold the Safety Bottom Line and Empower Innovative Development of New Biomedical Technologies with High-quality Non-clinical Research

Cheng Tao

Hospital of Hematology, Chinese Academy of Medical Sciences(Institute of Hematology, Chinese Academy of Medical Sciences)

The Regulations on the Administration of Clinical Research and Clinical Transformation Application of Biomedical New Technologies (Decree No. 818 of the State Council, hereinafter referred to as the Regulations) will come into force on May 1 this year. As an important milestone marking the legalization, standardization and systematization of China’s biomedical sector, the Regulations provide institutional guarantee for the innovative development of new biomedical technologies. As initiating institutions of clinical research, we must fully and accurately understand the policy spirit, take the initiative to assume primary responsibilities, and conduct clinical research and clinical transformation application while strictly safeguarding the safety bottom line.

I. Anchor Clinical Needs and Adhere to the Original Essence of Innovation in Non-clinical Research

Non-clinical research is the primary link for new biomedical technologies advancing toward clinical research. Its core value lies in solving unmet clinical diagnosis and treatment challenges. It must always be oriented to practical clinical problems, take innovation as the core, and ensure that all preliminary explorations deliver genuine clinical significance and translational value.

The core principles of the Regulations — adhering to innovation-driven development and balancing development with safety — require clinical research initiating institutions to channel innovative resources toward technologies with real clinical value, and avoid resource waste caused by disordered R&D and duplicated investment. We should uphold the orientation of original innovation, conduct fundamental innovation based on therapeutic mechanisms, technical routes and clinical protocols, refrain from simply copying or blindly following international models, actively pursue breakthroughs in technical design, research methodologies and evaluation systems, and strive to develop new biomedical technologies with clear research value.

Only by deeply recognizing the limitations of existing diagnosis and treatment methods and clarifying the clinical positioning of technologies can we consolidate the core advantages of new technologies in safety and efficacy, and ensure that non-clinical research aligns with clinical needs from the very beginning.

Non-clinical research guided by clinical needs can not only efficiently screen technical directions with clinical value and prevent mid-stream suspension of subsequent clinical research due to lack of practical value, but also pool innovative resources into fields with urgent clinical demand, definite curative effect and controllable risks, enabling new biomedical technologies to truly serve people’s health needs.

II. Strictly Control Test Article Quality and Consolidate a Solid Foundation for Non-clinical Research

The quality of test articles directly determines the reliability of non-clinical research data and the safety of clinical research, serving as the core foundation running through the entire life cycle of technological R&D. Integrating safety and efficacy into the whole R&D process is an inherent requirement for ensuring sound non-clinical research and a key measure to implement the safety bottom line stipulated by the Regulations.

The R&D and preparation of test articles shall adopt production processes and a quality management system compatible with technical characteristics. Premises, facilities, equipment and personnel qualifications shall strictly comply with relevant requirements to ensure clear technical routes and stable and controllable processes. Adhering to high-standard requirements, we shall build a full-process quality control strategy for test articles, embedding quality objectives, risk prevention and control, and key quality criteria into every R&D link. We shall scientifically define critical process parameters and quality standards, continuously optimize quality control indicators and testing systems, improve quality management models, and guarantee the safety, efficacy and quality stability of test articles.

Standardized and high-level preparation processes for test articles ensure the authenticity and reproducibility of non-clinical research data, lay a reliable material foundation for subsequent clinical research, and prevent research failure and increased risks to research subjects caused by poor test article quality.

III. Implement Scientific and Standardized Practice and Strictly Guard the Safety Threshold of Non-clinical Research

The core mission of non-clinical research is to systematically evaluate the safety and efficacy of technologies prior to human trials, and provide scientific evidence for clinical research protocol design and risk prevention and control. The Regulations clearly stipulate that clinical research of new biomedical technologies can only be carried out after verification of safety and efficacy via non-clinical research. This rigid requirement highlights the irreplaceable role of non-clinical research.

A rigorous quality management and control system shall be established for conducting non-clinical research. Research design shall closely fit the characteristics and expected therapeutic goals of new technologies to ensure scientific rationality in research depth and scope. By formulating rigorous research protocols and completing systematic evaluation of safety, efficacy and other indicators, we shall consolidate the foundation for the safety and scientificity of clinical research with authentic, complete and sufficient experimental data.

With the advancement of life science technologies, advanced tools such as microphysiological systems, organoids and in vitro three-dimensional culture models have provided evaluation carriers closer to human physiological conditions for non-clinical research, effectively making up for species differences inherent in traditional animal models.

The issuance of the Regulations and supporting documents has defined standardized pathways for non-clinical research on new biomedical technologies and put forward clear requirements for clinical research initiating institutions to fully fulfill their primary responsibilities. As the first safety threshold for technologies entering clinical transformation, non-clinical research must adopt stringent supervision and full-process compliance, and firmly prohibit irregular acts such as data fraud.

Only by adhering to clinical demand-oriented original innovation, strictly controlling test article quality to consolidate research foundations, and comprehensively evaluating safety and efficacy through scientific and rigorous verification can we truly uphold the safety bottom line. Moving forward, clinical research initiating institutions shall rely on high-quality non-clinical research data as solid support, ensure that scientific and technological innovation carries out standardized clinical transformation and application on a compliant track, effectively promote the translation of China’s new biomedical technologies from laboratories to clinical practice, turn innovative achievements into benefits for the public, and contribute to the construction of a Healthy China and the high-quality development of the biomedical industry.

Supporting and Promoting Clinical Transformation and Application of New Biomedical Technologies through High-quality Clinical Research for the Benefit of the Public

Zhang Shuyang

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

On May 1, 2026, the Regulations on the Administration of Clinical Research and Clinical Transformation Application of Biomedical New Technologies (State Council Decree No. 818, hereinafter referred to as the Regulations) will be officially implemented, marking that the regulation of new biomedical technologies in China has entered a new stage of legalization and refined governance. Clinical research institutions should embed the safety concept into every link and conduct high-quality clinical research on new biomedical technologies with a rigorous and responsible attitude.

I. Management Systems: Precondition and Guarantee for Standardized Clinical Research

Clinical research is a rule-based scientific practice rather than unregulated exploration. Its standardization is not an externally imposed constraint, but an inherent requirement to safeguard data credibility and the legitimate rights and interests of research subjects.

The Regulations and supporting documents aim to provide clear operational guidelines for researchers and prevent various risks arising from implementation deviations. In accordance with the Regulations and relevant supporting documents, clinical research institutions shall set up dedicated management departments to coordinate core functions including ethical review, project filing and quality control, effectively eliminating connection gaps caused by multiple overlapping management and ensuring that research activities follow established scientific pathways throughout the whole lifecycle.

A sound institutional system, qualified facility conditions and adequate personnel training are essential prerequisites for carrying out high-quality clinical research, as well as the foundation for ensuring standardized research operations and consolidating research credibility and safety.

II. Clinical Value and Subject Rights: Core Criteria for Project Initiation and Ethical Review

Clinical demand is the starting point for clinical research institutions to select new biomedical technologies. Priority shall be given to innovative technologies targeting diseases that cannot be effectively addressed by existing treatments. Standardized clinical research shall be conducted to verify their safety and efficacy, accelerating their transformation and application in clinical treatment.

While bringing clinical therapeutic benefits, new biomedical technologies may carry unpredictable risks. The Regulations clearly require strengthened whole-process safety management, prohibiting any harm to human health, violation of ethical principles, or damage to public interests and national security.

Therefore, clinical research on new biomedical technologies shall comply with general ethical norms, and additionally conduct targeted review against potential ethical risks inherent to the technologies, with comprehensive and adequate response measures in place. All clinical research must adhere to the people-health-centered principle, prioritize subject safety, ensure full informed consent, respect the will of research participants, and protect their personal privacy and legitimate rights and interests. Low-level repetitive research and blind follow-up studies must be firmly avoided, and limited resources shall be concentrated on truly innovative directions to benefit the general public.

III. Scientific and Rigorous Research Design: Key to Successful Clinical Research

New biomedical technologies feature strong exploratory nature and high uncertainty. Their clinical research must adopt scientifically rigorous protocols to manage risks and improve research quality.

The scientificity of a protocol originates from solid preliminary demonstration. Initiating and research institutions shall cooperate closely, conduct thorough investigations, and systematically evaluate technical principles, mechanisms of action and non-clinical research conclusions to lay a reliable foundation for protocol design.

Rigor is reflected in standardization and refinement. Clinical research institutions shall formulate legally compliant and operable research protocols tailored to technical characteristics, including strict inclusion and exclusion criteria, accurate sample size estimation, clear outcome indicators, and comprehensive adverse event response plans. Controllability shall be embedded into the whole-process risk management mechanism to advance research while balancing scientific validity and risk control. A scientifically rigorous research protocol enables steady progress of clinical research and achieves successful transition from exploratory study to conclusive verification.

IV. Authentic and Reliable Data: An Inviolable Bottom Line for Clinical Research

Data quality is the lifeline of clinical research. Its authenticity and reliability directly determine the credibility of research conclusions and the safety of research subjects. Such data provides evidence for subsequent clinical transformation and lays a foundation for the R&D of new mechanisms and technologies, bearing important scientific value.

Research institutions shall establish a dynamic whole-process data management system relying on real-time data collection, logical verification and anomaly early warning to identify and correct data deviations at an early stage, resolve risks at the initial stage, and prevent accumulated problems from affecting final analysis. Regular traceability inspections of original documents and electronic records shall be carried out, and institutionalized measures shall be adopted to rectify weak links in workflows, preventing unintentional deviations from evolving into systematic errors and strictly maintaining the quality bottom line. The combination of dynamic monitoring and independent review ensures all data is verifiable, enabling research conclusions to truly serve clinical practice.

V. Multicenter Collaboration: An Important Direction toward High-level Research

The core challenge of multicenter research lies in consistent and homogeneous implementation across all centers. Inconsistent implementation standards and discrepancies in data collection and event judgment will lead to uninterpretable pooled data and even contradictory conclusions.

Leading institutions shall strengthen coordination, urge all participating institutions to strictly follow unified protocols, ensure all data are measured by the same standard, and enable pooled analysis and mutual verification of results from different centers. In consideration of the replicability and promotion of medical technologies, reproducibility verification shall be conducted simultaneously in multicenter studies to ensure consistent results when standardized procedures are followed by other institutions and personnel.

A collaborative management mechanism with unified standards and smooth information communication shall be established, and standardized operating procedures covering protocol implementation, data collection and adverse event handling shall be formulated to ensure accurate understanding and full implementation by researchers at all centers. Institutionalized collaboration consolidates implementation consistency, effectively improves data quality, guarantees reliable research conclusions, and accelerates the transformation of high-level clinical research achievements into practical application.

The promulgation of the Regulations fills the legislative gap in the development of new biomedical technologies in China. It serves as a code of conduct for institutions initiating and implementing clinical research, as well as the legal guarantee and constraint for conducting high-quality and standardized clinical research. With the support of the Regulations, the development of biomedical technologies in China will surely follow an efficient and steady path, better meeting clinical and social needs and enhancing people’s well-being.

Source: Website of the National Health Commission of the People’s Republic of China