Health Commissions of all provinces, autonomous regions, municipalities directly under the Central Government, and Xinjiang Production and Construction Corps; Medical Management Service Guidance Center of the National Health Commission; China National Center for Biotechnology Development:

To implement the Regulations on the Administration of Clinical Research and Clinical Transformation & Application of New Biomedical Technologies, standardize the examination and approval procedures for the clinical transformation and application of new biomedical technologies, promote the innovative development and compliant transformation of new biomedical technologies, safeguard medical quality and safety, and protect people’s health, the National Health Commission has formulated the Work Specifications for the Examination and Approval of Clinical Transformation and Application of New Biomedical Technologies (Trial). This document is hereby issued for strict compliance and implementation.

National Health CommissionApril 30, 2026

Work Specifications for the Examination and Approval of Clinical Transformation and Application of New Biomedical Technologies

(Trial)

Chapter I General Provisions

Article 1These Specifications are formulated in accordance with the Regulations on the Administration of Clinical Research and Clinical Transformation & Application of New Biomedical Technologies, for the purpose of standardizing the examination and approval of clinical transformation and application of new biomedical technologies, boosting their innovative development and compliant transformation, and ensuring medical quality and safety.

Article 2These Specifications shall apply to the application, acceptance, review, decision-making, supervision and administration of the examination and approval for clinical transformation and application of new biomedical technologies.

The term new biomedical technologies as used herein refers to professional medical methods and measures that adopt biological principles, act on human cellular and molecular levels, aim to judge health status, prevent and treat diseases and enhance health, and have not yet been applied clinically within the territory of China.

Article 3New biomedical technologies included in the Guiding List for the Filing of Clinical Research on New Biomedical Technologies shall be incorporated into the scope of examination and approval for clinical transformation and application if they meet one of the following requirements:

1. Highly personalized, with no domestically approved marketed drugs adopting the same mechanism or principle, nor confirmed pivotal clinical trials initiated for such drugs;

2. Used for the treatment of rare diseases, with no domestically approved marketed drugs adopting the same mechanism or principle for the same indications, nor confirmed pivotal clinical trials initiated for such drugs.

Technologies that conform to the definition of medical devices as stipulated in the Regulations on the Supervision and Administration of Medical Devices shall go through registration procedures in accordance with medical device laws and regulations, and shall not be included in the scope of examination and approval specified herein.

Article 4The National Health Commission shall be responsible for the nationwide examination, approval, supervision and administration of the clinical transformation and application of new biomedical technologies.

The China National Center for Biotechnology Development (hereinafter referred to as CNCBD), as a professional institution, shall undertake the assessment of applications for clinical transformation and application of new biomedical technologies, and cooperate in post-transformation reassessment work.

The Medical Management Service Guidance Center of the National Health Commission (hereinafter referred to as MMSGC), as a professional institution, shall undertake post-transformation reassessment, and cooperate in the assessment of institutional and personnel qualifications as well as clinical application operation specifications for new biomedical technologies.

CNCBD and MMSGC shall establish an internal coordination mechanism to ensure overall planning and coordination of assessment and reassessment work.

Health authorities at or above the county level shall be responsible for the supervision and administration of the clinical transformation and application of new biomedical technologies within their respective administrative regions.

Article 5The examination and approval for clinical transformation and application of new biomedical technologies shall adhere to the principles of lawfulness and compliance, fairness and impartiality, scientific prudence, be clinical value-oriented, encourage innovation, ensure safety, and actively promote the benefits of new biomedical technologies to patients.

Chapter II Application and Acceptance

Article 6An application for clinical transformation and application of a new biomedical technology shall satisfy all of the following conditions simultaneously:

1. Completion of legally filed clinical research on the new biomedical technology;

2. Clinical research proves the technology is safe, effective and ethically compliant;

3. During the clinical research phase, multi-center institutions independently implemented the technology in compliance with clinical application operation specifications and reached consistent conclusions on safety and efficacy.

Article 7Upon completion of clinical research, technologies falling within the scope specified in Article 3 of these Specifications may apply for clinical transformation and application. The institution initiating the clinical research (hereinafter referred to as the Applicant Institution) shall submit an application to the National Health Commission, together with the Application Form for Clinical Transformation and Application of New Biomedical Technologies (see Appendix 1 for template) and relevant supporting documents.

The Applicant Institution shall submit materials truthfully, reflect actual conditions, and be liable for the authenticity, accuracy, completeness of the application materials and corresponding legal liabilities.

Article 8After receiving an application, the Administrative Approval Acceptance Window of the National Health Commission (located at the office area of CNCBD) shall conduct formal examination of the application materials (see Appendix 2 for formal examination requirements), and handle the application as follows:

1. If the application is beyond the authority of this authority or outside the approval scope, a decision of non-acceptance shall be made and a Non-Acceptance Notice shall be issued;

2. If the application materials are incomplete or non-compliant in form, a Notice for Supplementary Materials shall be issued within 5 working days upon receipt, specifying all required supplementary items in a one-off manner. If the supplemented materials still fail to meet requirements, further supplementation may be requested;

3. If the application falls within the acceptance scope with complete and compliant materials, an acceptance decision shall be made and an Acceptance Notice shall be issued.

Chapter III Review and Decision-Making

Article 9The review of clinical transformation and application of new biomedical technologies shall adopt a combined model of expert assessment and departmental verification.

Article 10Within 5 working days from the date of accepting an application, the National Health Commission shall transfer the application materials to CNCBD for assessment.

Upon receiving the materials, CNCBD shall, together with MMSGC, select experts from the expert database for clinical research and clinical transformation application of new biomedical technologies, organize document verification, technical assessment and ethical assessment, put forward assessment opinions, and submit them to the National Health Commission. Experts outside the database may be invited to participate when necessary.

Article 11CNCBD and MMSGC shall organize experts to verify the authenticity, accuracy and completeness of application materials, and classify the risk level of the technology in accordance with the Guidelines for Risk Classification of New Biomedical Technologies. Verification methods include but are not limited to documentary review and on-site inspection.

If supplementary materials are required during verification, the Applicant Institution shall be notified in writing promptly and shall supplement the materials as required in a timely manner.

As needed for verification, the Applicant Institution, clinical research institutions and relevant personnel shall be required to answer technical questions on-site, and shall provide cooperation.

If errors, omissions, major problems are found in the materials, or the Applicant Institution voluntarily withdraws the application, CNCBD may put forward assessment opinions of Re-examination Postponed or Review Terminated.

The Guidelines for Risk Classification of New Biomedical Technologies shall be separately formulated by CNCBD jointly with MMSGC.

Article 12For applications passing document verification, CNCBD and MMSGC shall organize experts to conduct technical and ethical assessment via online written review, panel evaluation or on-site assessment.Technical assessment focuses on technological maturity, safety, efficacy, qualification requirements for medical institutions and professionals, clinical application operation specifications, quality control standards and risk prevention and control measures.Ethical assessment focuses on ethical compliance, rights and interests protection, social ethics and public security.On-site assessment may be organized for high-risk technologies, highly controversial technologies, or other cases deemed necessary by experts.

If CNCBD confirms that an application is outside the approval scope during verification and assessment, it shall put forward an assessment opinion of Review Terminated.

Article 13Based on document verification, technical assessment and ethical assessment, CNCBD shall organize experts to deliver assessment opinions including Recommended for Approval, Recommended for Rejection, Re-examination Postponed and Review Terminated, and compile an assessment report.

If multi-center clinical research proves the technology is safe, effective, mature, stable and ethically compliant, the opinion of Recommended for Approval shall be put forward.

An opinion of Recommended for Rejection may be given under any of the following circumstances:

1. Application documents indicate obvious immaturity or major technical defects;

2. Documents fail to prove definite safety, efficacy and quality controllability, or the technology is deemed clinically unnecessary with risks outweighing benefits;

3. Other qualified medical institutions and professionals cannot reach consistent safety and efficacy conclusions when implementing the technology in compliance with operational specifications;

4. Unacceptable risks exist in social ethics, public security and social stability; or lacking rights protection mechanisms, feasible risk control measures and protection for vulnerable groups;

5. The Applicant Institution fails to supplement materials as required;

6. Refusal or unjustified failure to cooperate with document verification and inspection;

7. Application materials are deemed untrue and cannot be verified during review and assessment;

8. Other circumstances where approval shall be denied as stipulated by laws and regulations.

Article 14For technologies Recommended for Approval, CNCBD shall compile technical interpretation materials, and submit them together with the assessment report, risk level, qualification requirements for institutions and professionals, and clinical application operation specifications to the National Health Commission.

Article 15For technologies Recommended for Rejection or Review Terminated, the Applicant Institution shall be informed with reasons stated. The Applicant Institution may raise objections based on submitted documents within 5 working days upon notification. CNCBD shall reassess the objections and feed back the results.

If the Applicant Institution still disagrees with the assessment result, CNCBD shall organize expert argumentation, form a final assessment opinion and submit it to the National Health Commission.

Article 16For technologies with the opinion of Re-examination Postponed, the Applicant Institution shall be notified of all required supplementary materials and the time limit in a one-off manner. After complete submission, CNCBD shall organize reassessment.

Article 17The National Health Commission shall make an approval decision within 15 working days upon receiving the assessment opinions submitted by CNCBD, and may organize inter-departmental verification during the period.

For technologies Approved, the National Health Commission shall issue an official announcement in a timely manner, disclosing the technology name, risk level, qualification requirements for implementing institutions and professionals, and clinical application operation specifications, and deliver the Approval Notice to the Applicant Institution.

For technologies Rejected or with Review Terminated, a Decision on Rejection of Administrative License or Review Termination Notice shall be issued with reasons stated, informing the Applicant Institution of the right and time limit for applying for administrative reconsideration or filing an administrative lawsuit, and delivered accordingly.

Article 18For new biomedical technologies intended for treating life-threatening diseases with no effective treatment available or urgently needed for public health emergencies, the Applicant Institution may submit an Application Form for Priority Review and Approval (see Appendix 3) when applying for clinical transformation and application.

Technologies included in the priority review scope shall be subject to the priority assessment procedure.

If an application under priority assessment fails to meet priority review requirements during verification and assessment, the priority procedure shall be terminated, and the application shall be assessed under the normal procedure with notification to the Applicant Institution.

Article 19In response to extraordinary major public health emergencies or other serious public health threats, the National Health Commission may approve the emergency application of ongoing clinical research technologies within a specified scope and time limit upon expert demonstration. Specific provisions shall be formulated separately.

Chapter IV Clinical Application Administration

Article 20The whole process of clinical application of approved new biomedical technologies, including biological sample collection, preparation, quality control, preservation and implementation, shall be carried out by qualified professionals in qualified medical institutions in accordance with relevant regulations and operational specifications.

High-risk technologies shall be limited to institutions participating in the original clinical research for 5 years after approval; medium-risk technologies for 3 years; low-risk technologies for 1 year. Upon expiry, if no circumstances specified in Paragraph 1 of Article 23 occur or reassessment confirms benefits far outweigh risks, other qualified medical institutions may carry out the technology and complete filing as restricted medical technologies.

No institution or individual shall apply unapproved new biomedical technologies to clinical practice.

Article 21Medical institutions shall assume primary responsibility for the clinical application administration of new biomedical technologies, and establish full-process management systems. Institutions shall strengthen quality control, and grant, adjust or revoke technical practice authority according to professional competence.

Medical institutions shall guarantee the right to informed consent of patients or their guardians and sign informed consent forms.

Institutions shall formulate risk prevention and control measures, emergency response plans and follow-up management systems.

Article 22Medical institutions shall report the clinical application of the technology case by case to the provincial health authority where they are located. In case of serious adverse reactions or medical incidents during application, institutions shall handle the matter properly and report to the provincial health authority immediately.

The aforesaid report shall be submitted via the information system for clinical research and clinical transformation of new biomedical technologies.

Article 23The National Health Commission shall organize reassessment on the safety and efficacy of an approved technology and suspend its clinical application under any of the following circumstances:

1. Updated scientific research leads to revised understanding of the technology’s safety and efficacy;

2. Serious adverse reactions or uncontrollable risks occur in clinical application;

3. Major social stability risks or incidents arise from clinical application;

4. Other circumstances stipulated by the National Health Commission.

Reassessment shall be implemented by MMSGC jointly with CNCBD, referring to the Working Procedures for Assessment on Clinical Application of Medical Technologies. Health economic assessment shall be conducted simultaneously with comparison against alternative medical technologies, drugs and medical devices for the same indications.

Experts participating in the initial approval assessment shall recuse themselves from reassessment.

If reassessment confirms the technology cannot guarantee safety and efficacy, the National Health Commission shall prohibit its clinical application and make a public announcement.

Article 24Provincial health authorities shall establish and improve the administration system for clinical application of new biomedical technologies and provide technical guidance. Health authorities at or above the county level shall conduct supervision and inspection within their jurisdiction, and impose penalties for violations in accordance with the Regulations on the Administration of Clinical Research and Clinical Transformation & Application of New Biomedical Technologies and other relevant laws and regulations.

Chapter V Supplementary Provisions

Article 25These Specifications shall be interpreted by the National Health Commission.

Article 26These Specifications shall come into force on May 1, 2026.

Appendices:

1. Application Form for Clinical Transformation and Application of New Biomedical Technologies

2. Formal Examination Requirements for Applications of Clinical Transformation and Application of New Biomedical Technologies

3. Application Form for Priority Review and Approval of Clinical Transformation and Application of New Biomedical Technologies

4. 

Scan the QR code to view the appendices.

Interpretation of the Notice on Issuing the Work Specifications for the Examination and Approval of Clinical Transformation and Application of New Biomedical Technologies (Trial)

I. Background of Formulation

In September 2025, the State Council promulgated the Regulations on the Administration of Clinical Research and Clinical Transformation & Application of New Biomedical Technologies (hereinafter referred to as the Regulations), which came into force on May 1 this year.

To standardize the examination and approval work for the clinical transformation and application of new biomedical technologies, the National Health Commission extensively solicited opinions and suggestions from relevant departments of the State Council, local governments, health authorities, medical and health institutions, biomedical enterprises, relevant experts and the general public through research, forums, field visits, special seminars, written consultation and public consultation. On this basis, the Commission formulated the Work Specifications for the Examination and Approval of Clinical Transformation and Application of New Biomedical Technologies (hereinafter referred to as the Work Specifications).

II. Main Content

The Work Specifications consists of five chapters with twenty-six articles in total.

Chapter I General Provisions clarifies the formulation purpose and legal basis, scope of application, approval scope, approval principles and administrative responsibilities.

Chapter II Application and Acceptance stipulates the qualification requirements for applications, application documents, as well as formal examination and acceptance procedures for the clinical transformation and application of new biomedical technologies.

Chapter III Review and Decision-Making defines the review mode combining expert assessment and departmental verification. It elaborates on core approval workflows including document verification, technical and ethical assessment, and the formulation of administrative licensing decisions, and specifies special approval channels such as priority review and emergency application.

Chapter IV Clinical Application Administration sets forth requirements on the clinical application management, medical quality and safety management, application status reporting, reassessment and supervision of newly approved biomedical technologies.

Chapter V Supplementary Provisions clarifies the right of interpretation and the effective date of the Work Specifications.

III. Explanation on Key Issues

(1) Scope of Approval

In accordance with the legislative spirit of the Regulations, and to promote the coordinated and complementary development of new biomedical technologies and the biomedical industry as well as advance medical scientific and technological innovation, Article 3 of the Work Specifications defines the approval scope. It clarifies that drugs and medical devices with clear product forms and eligible for standardized and large-scale production shall not be included in the approval scope for the clinical transformation and application of new biomedical technologies.

In addition, the criteria for defining "the same mechanism and principle" within the approval scope vary by technical characteristics, and classified specific criteria will be separately formulated in follow-up research.

(2) Technical Verification at the Clinical Research Stage

Articles 33 and 34 of the Regulations stipulate that upon approval of the clinical transformation and application of a new biomedical technology, the clinical application operational specifications shall be publicly released, and qualified institutions and personnel may apply the technology in accordance with relevant provisions.

Only when multi-center institutions independently implement the technology in compliance with clinical application operational specifications during the clinical research stage and reach consistent conclusions on safety and efficacy can the repeatability and scalability of the technology be verified. This ensures that other institutions and professionals can apply the technology smoothly by following specifications, so as to better protect public health.

(3) Risk Classification Management After Approval

The overall cycle from invention, conceptual verification and pre-clinical evaluation to clinical research of new biomedical technologies is generally relatively short. Subject to the current level of scientific and technological development and cognitive limitations, some unknown safety risks or long-term potential risks may not be fully exposed during the research process.

Therefore, it is necessary to classify technologies by risk level and implement differentiated supervision, restrict the scope of application within a certain period, and conduct follow-up monitoring on technical application. This helps accumulate sufficient real-world evidence, better control risks, and maximize the protection of public safety.

Source: Official Website of the National Health Commission