China Issues Landmark Regulation on Biomedical New Technologies

State Council Decree No. 818 – Effective May 1, 2026 I NHC Guiding Principles issued April 30, 2026

China has established a new dedicated regulatory framework for biomedical new technologies, filling a longstanding gap in the governance of advanced therapies including gene technologies, cell therapies, regenerative medicine, and highly personalized treatments.

The primary instrument is the “Regulations on the Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies” (State Council Decree No. 818), passed at the 68th Executive Meeting of the State Council on September 12, 2025, published on September 28, 2025, and effective from  May 1, 2026. This is a State Council-level regulation — binding law, not departmental guidance — and carries the full legislative authority of a national administrative regulation.

On April 30, 2026, the National Health Commission (NHC), with the agreement of the National Medical Products Administration (NMPA), separately issued the “Guiding Principles for Defining Biomedical New Technologies and Drugs or Medical Devices (Interim)”. These Guiding Principles implement Article 55 of Decree 818 and establish the definitional framework for distinguishing biomedical new technologies from drugs and medical devices.

The framework is particularly relevant for:

• Gene technologies
• Cell therapies
• Regenerative medicine
• Highly personalized treatments
• Technologies addressing rare diseases or conditions lacking effective therapies

The Regulation introduces a series of specific requirements and constraints that directly affect how research in this space can be structured and conducted in China.

A New Regulatory Pathway for Biomedical New Technologies

The Regulation establishes how China will govern biomedical new technologies throughout the clinical development lifecycle, from early clinical research through to clinical translational application.

The framework is intended to support innovation while strengthening safety oversight, ethical governance, and coordination between health and product regulators. It operates alongside and is explicitly coordinated with existing drug and medical device systems under the Drug Administration Law and the Medical Device Supervision and Administration Regulations.

The Regulation emphasize technologies that are:

• Highly innovative
• Highly personalized
• Difficult to industrialize as conventional drugs or devices
• Intended to address unmet clinical needs, including rare diseases

The framework also recognizes that biomedical technologies require different regulatory treatment at different development stages, particularly between early clinical research and later translational application. The accompanying policy materials describe this as a “broad entry, strict exit” model: filing-based management during clinical research, and rigorous approval during translational application.

Key Structural Requirements: What Companies Must Know

The framework is supported by a series of mandatory structural requirements that govern sponsor eligibility, research site qualification, filing procedures, participant protections, and record-keeping obligations.

Sponsor Must Be Chinese Legal Entities (Article 10)

The Regulation requires that the clinical research sponsor — the institution initiating the research — must be a legal person established in accordance with the law within the territory of China. Foreign companies without a Chinese-incorporated entity cannot directly act as sponsors. This is the foundational structural constraint of the framework and must be the starting point for any foreign company’s China strategy for biomedical new technologies.

Clinical Research Must Be Conducted at Class 3A Hospitals (Article 11)

The Regulation specifies that clinical research institutions — the hospitals or institutions where research is actually conducted — must be Class 3A hospitals, China’s highest hospital tier. This is a hard eligibility threshold, not a recommendation. Institutions must also have qualified academic and ethics committees, appropriate facilities and personnel, and stable research funding. This significantly constrains institutional partnership options and means foreign companies must identify and engage with qualifying Class 3A partners early.

Filing Window: 5 Working Days (Article 15)

After a proposed clinical research project has passed both academic review and ethics review, the clinical research institution must submit its NHC filing within 5 working days. This tight window has direct implications for research setup timelines and internal governance processes.

Sponsors May Not Charge Participants (Article 20)

Clinical research sponsors and institutions are prohibited from charging participants any fees related to the clinical research. This applies regardless of the cost of the technology being investigated and has direct implications for research budget design and cost recovery models.

Record Retention: 30 Years, Permanent for Offspring Research (Article 22)

Research records and original materials must be retained for 30 years after the research concludes. For research involving offspring, which is relevant for certain gene and reproductive technologies, records must be retained permanently. This imposes significant long-term data management obligations on both sponsors and institutions.

Transition Provision for Existing Research (Article 57)

Biomedical new technology clinical research already underway before 1 May 2026 may continue to be implemented according to the existing research plan. However, clinical research institutions must complete NHC filing under the new Regulation within 1 month of the effective date. Companies with ongoing research in this space should confirm compliance with this transition requirement as a priority.

Filing Guidance List Will Guide Classification

A central feature of the framework is the new “Guidance List for Filing Clinical Research of Biomedical New Technologies,” (the Filing Guidance List), established under the Guiding Principles.

During the clinical research stage, sponsors must independently determine whether a proposed technology qualifies as a biomedical new technology by referring to the list, which will be updated as technologies evolve and clinical needs change.

• Technologies classified as biomedical new technologies must comply with the NHC’s filing requirements and naming standards
• Technologies classified as drugs or medical devices must instead proceed through existing NMPA regulatory pathways

Technologies Must Meet Inclusion Criteria

To qualify for inclusion in the Filing Guidance List, technologies must:

• Comply with Chinese laws, ethics requirements, and national policies
• Have a clear medical purpose (addressing chronic, infectious, pediatric, or rare diseases)
• Demonstrate a clearly understood mechanism of action at the molecular or cellular level
• Be supported by sufficient non-clinical research (laboratory and animal studies) demonstrating safety and efficacy
• Not already have been clinically applied in China

Sponsors may also propose additions to the list by submitting supporting materials to the NHC, including standardized technology names, medical purposes, mechanisms of action, compliant non-clinical research reports, and justification of clinical necessity.

Removal Procedures and Exit Controls

The framework establishes both direct removal procedures and removal following regulatory review. Technologies may be directly removed if they:

• Become prohibited by law
• Raise major ethical concerns
• Demonstrate significant safety or efficacy problems
• Create uncontrollable risks or serious adverse social impacts

Once directly removed, existing clinical research projects must be terminated promptly while protecting participant rights.

The NHC and NMPA may also remove technologies following joint review if equivalent drugs or medical devices with the same indications and mechanisms have been approved in China, or if the technology has already been approved as a medical technology for clinical translational application.

After removal through review, new related clinical research must comply with the “Administrative Measures for Investigator-Initiated Clinical Research Conducted by Medical and Health Institutions”. Existing filed studies may continue or terminate depending on ethical review outcomes.

Translational Application: Narrowly Limited Eligibility

The Regulation imposes narrower eligibility standards during the clinical translational application stage.

Only technologies already included in the Filing Guidance List and meeting one of the following conditions fall within the approval scope:

• Highly personalized technologies for which no drug using the same mechanism has obtained marketing authorization or entered confirmatory clinical trials in China; or
• Technologies for rare disease treatment where no drug with the same mechanism and indication has obtained marketing authorization or entered confirmatory clinical trials in China.

Technologies meeting China’s legal definition of a medical device are excluded from the translational application pathway and must proceed through standard medical device registration.

The NHC will organize professional institutions to evaluate applications. Technologies proven safe and effective through clinical research, compliant with ethical requirements, and reproducible under standardized procedures may be approved and incorporated into medical technology management.

Priority Review (Article 32)

The Regulation provides for priority review and approval for technologies addressing serious life-threatening diseases for which no effective treatment currently exists, and technologies urgently needed to address public health emergencies. This is a formal statutory mechanism, not a discretionary process, and represents a significant strategic advantage for companies developing technologies in these areas.

Ethics and Lifecycle Oversight

The Regulation places heavy emphasis on ethical governance, risk control, and lifecycle supervision.

The NHC has stated that technical evaluation determines whether a technology “can be used,” while ethical evaluation determines whether it “should be used.” Both are mandatory and equally weighted in the review process.

Approved technologies will be subject to risk-based supervision periods. The NHC Q&A interpretation indicates these periods are:

• High-risk technologies: 5 years
• Medium-risk technologies: 3 years
• Low-risk technologies: 1 year

Note: These specific durations are drawn from the NHC’s Q&A interpretation document, not from the text of Decree 818 itself. The Regulation establishes the supervision framework but does not specify these periods directly.

During supervision periods, use may be restricted to participating research institutions while regulators collect additional safety and follow-up data.

The framework imposes extensive compliance obligations relating to:

• Biological sample management
• Quality-control systems
• Practitioner authorization
• Informed consent
• Emergency risk management
• Data traceability

Data falsification is explicitly prohibited. Violations including submission of false materials or falsified data carry severe penalties: for institutions, fines of 2 to 5 times the proceeds and a 2-year ban on clinical research; for responsible individuals, fines and 3-year bans. Where violations cause harm, criminal liability may apply under Article 54.

Implications for Pharmaceutical and Biotechnology Companies

Companies developing cell therapies, gene-editing technologies, regenerative medicine products, or personalized therapies face a layered set of requirements under the new framework. The following are the key strategic and compliance considerations:

• Chinese entity requirement: Foreign companies must establish or partner through a Chinese-incorporated legal entity to act as clinical research sponsor. This is a non-negotiable structural prerequisite and should be the first consideration in any China development strategy for biomedical new technologies.
• Institutional partnerships: Research partnerships must be with Class 3A hospitals that have qualifying academic and ethics committees, facilities, and personnel. Identifying and securing these partnerships early in the development timeline is critical.
• Pathway determination: Companies must carefully evaluate whether a technology is better suited for the biomedical new technology pathway or traditional drug and medical device pathways. That determination affects clinical development strategy, filing obligations, translational application opportunities, and commercialization planning.
• Rare disease and life-threatening conditions: Companies developing highly personalized or rare disease technologies may find new opportunities under the translational application framework. The formal priority review mechanism under Article 32 is a significant advantage where applicable.
• Ongoing research: Companies with clinical research already underway in China before May 1, 2026 must complete NHC filing within 1 month of the effective date.
• Compliance infrastructure: The 30-year record retention requirement, 5 working-day filing window, fee prohibition, and data integrity obligations require robust compliance systems from the outset.

The framework also signals heightened regulatory focus on ethics governance, quality systems, traceability, and clinical research data integrity across the board.

For companies seeking to navigate China’s evolving regulatory framework for advanced therapies and biomedical innovation, contact Cisema today.

Further Information

• Explore Cisema’s Pharmaceutical Consulting services

References

• Notice of the National Health Commission on Issuing the Guiding Principles for Defining New Biomedical Technologies and Drugs and Medical Devices (Interim)  ‍
• Questions and Answers on the Interpretation of the Regulations on the Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies
• Seizing the Opportunities Presented by the Implementation of the Regulations to Promote High-Quality Clinical Research and Clinical Translational Application of New Biomedical Technologies