Key Points Analysis of the Regulations on the Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies (Mainland China)

In September 2025, the State Council promulgated the Regulations on the Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies (hereinafter referred to as the “Regulations”).  As China’s first specialized administrative regulation in the biomedical field, the Regulations will come into effect on May 1, 2026, marking a new stage of law-based governance over new biomedical technologies in China.  This article provides an analysis of the key provisions of the Regulations for reference.

I. Dual-Track Regulation of “Filing + Evaluation”

The Regulations overturn the previously ambiguous regulatory approach to clinical research on new biomedical technologies and establish a framework of “pre-filing plus dynamic evaluation.”  According to Articles 8 to 17 of the Regulations, clinical research must meet three sets of requirements:

First, entity compliance.  The sponsoring institution must be a legally established legal person within China.  Implementing institutions are limited to Grade A tertiary hospitals, which must have dedicated academic committees and ethics committees.

Second, procedural compliance.  Research projects must first pass institutional academic review and ethics review, and then be filed with the health administrative department of the State Council within five working days.  Nine categories of statutory materials must be submitted, including the research protocol, risk contingency plans, and templates of informed consent forms.

Third, safety compliance.  Prior to the commencement of clinical research, non-clinical studies such as laboratory research and animal experiments must be completed.  Research on biomedical technologies that are expressly prohibited or that involve major ethical concerns is strictly forbidden.

These provisions clearly identify the first point of compliance responsibility: clinical research institutions and sponsoring institutions bear legal responsibility for the authenticity and accuracy of the filed materials.  Fabrication or tampering with research records will result in severe penalties.  Of particular note is Article 17 of the Regulations, which grants the health administrative department of the State Council mandatory post hoc evaluation authority.  For research projects that pose risks, the authority may order suspension, modification, or termination.  Accordingly, institutions should establish real-time risk monitoring mechanisms to avoid project suspension or termination due to failed evaluations and the resulting losses.

II. “Dual-Track Classification” plus an “Approval System”

Article 55 of the Regulations establishes a “dual-track classification” rule distinguishing new biomedical technologies from drugs and medical devices.  Under this provision, the health administrative department of the State Council, together with the drug regulatory authority, will formulate guiding principles for classification.  This means that technologies with clear “drug-like” characteristics must follow the drug registration and approval process, while technologies primarily oriented toward clinical application are subject to the translational approval pathway prescribed by the Regulations.

However, the approval process for clinical translation is also strictly regulated. According to Article 30 and related provisions, translational applications must be applied for by the sponsoring institution to the health administrative department of the State Council.  After technical and ethical evaluations, the competent authority will make a decision within the statutory time limit.  Upon approval, the authority will simultaneously disclose the qualifications of institutions authorized to apply the technology, personnel requirements, and operational standards.  This provision effectively addresses the previous disorder caused by the lack of a legal basis for translational application.  Relevant institutions are therefore advised to assess in advance the regulatory classification of their technologies to avoid compliance risks arising from choosing an incorrect regulatory pathway.

III.   Comprehensive Protection of Research Subjects’ Rights and Interests

The Regulations take the protection of research subjects’ rights and interests as a core legislative principle, establishing a full-chain regulatory system covering informed consent, prohibition of charges, remedies for harm, and privacy protection.  These provisions are mandatory and non-negotiable.

First, stricter informed consent requirements.  Article 19 requires that written informed consent be obtained from subjects or their guardians.  The information provided must be clear and understandable.  If changes to the research protocol affect subjects’ rights and interests, consent must be obtained again.  Obtaining consent through deception, coercion, or other improper means is strictly prohibited.

Second, the principle of prohibiting charges.  Article 20 clearly stipulates that clinical research must not charge subjects any related fees, preventing commercial interests from undermining the public welfare nature of the research.

Third, a damage remedy mechanism.  Article 27 provides that if clinical research causes health damage, timely treatment must be provided.  Treatment costs shall be borne by the clinical research sponsoring institution and the clinical research institution according to fault-based liability, and the purchase of commercial insurance to spread risks is encouraged.

Fourth, privacy protection obligations.  Article 28 requires relevant institutions to protect subjects’ personal information and privacy in accordance with the law.

Acts that infringe upon subjects’ rights and interests will be subject to penalties.  Accordingly, institutions are advised to establish dedicated mechanisms for the protection of subjects’ rights within their compliance management systems, incorporating informed consent procedures and privacy protection measures into standardized management to avoid civil liability or administrative penalties arising from procedural defects.

IV.  Full-Process Accountability and Traceability

By clarifying the responsibilities of all parties, detailing types of violations, and increasing penalties, the Regulations establish an accountability system that creates a strong deterrent against non-compliance.

With respect to responsible parties, the Regulations clearly define the respective obligations of clinical research sponsoring institutions, implementing institutions, project leaders, and participating personnel, forming a closed loop of responsibility.  Regarding violations, they enumerate typical illegal acts such as conducting research without filing, exceeding the approved scope of translational application, falsifying research data, and infringing upon subjects’ rights and interests.  Concerning penalties, a tiered system is established, including warnings, fines, revocation of licenses, and lifetime bans from practice; serious cases may result in criminal liability.

Of particular note is the strong deterrent effect of penalties imposed on medical professionals.  In serious cases, practitioners may have their licenses revoked and be permanently prohibited from engaging in related research.

Conclusion

Overall, the Regulations establish a comprehensive compliance framework for the research, development, and application of new biomedical technologies, encouraging innovation while firmly safeguarding safety.  Relevant institutions should embed compliance management throughout the entire process of research and translation, proactively align with filing and approval requirements, clarify applicable regulatory pathways, and improve mechanisms for protecting subjects’ rights and interests to avoid legal risks arising from compliance deficiencies.