On September 28, 2025, the State Council of the People's Republic of China promulgated the Regulations on Administration of Clinical Study and Clinical Translational Application of New Biomedical Technologies (the “Regulation”), effective on May 1, 2026. The Regulation introduces clearer regulatory paths and compliance requirements for clinical studies and clinical translation and application of new biomedical technologies in the fields of cell and gene therapies, including stem cell therapy, gene editing, CAR-T cell therapy, etc.

1. Scope of Application

Under the Regulation, the term “biomedical new technologies” or “new biotech” is defined as medical techniques and measures that, for the purposes of assessing health status, preventing or treating diseases, or improving health, apply biological principles at the cellular or molecular level of the human body and have not yet been clinically applied within China (“New Biotechs”, each a “New Biotech”).[1] Clinical studies of the New Biotechs involving use of drugs and medical devices must also follow the laws and regulations governing drugs and medical devices[2]. To differentiate New Biotechs from conventional drugs and devices, National Health Commission (the “NHC”), together with the National Medical Products Administration (the “NMPA”), is anticipated to establish specific guidelines.[3]

2. Clinical Study

(a) Filing-based system

The scope of clinical studies on the New Biotechs is defined to include studies that (i) directly operate on the human body; (ii) manipulate ex vivo cells, tissues, or organs that are subsequently implanted or introduced into the human body; (iii) manipulate human germ cells, zygotes, or embryos that are later implanted into the human body for development; and (iv) use other methods as specified by the NHC.[4] Notably, technologies that raise significant ethical concerns, such as surrogacy technology and cloning therapy, shall remain strictly prohibited from clinical research.[5]

Pre-clinical studies including lab studies and animal testing demonstrating the safety and efficacy of the New Biotechs should be conducted before filing for clinical studies. The clinical studies of the New Biotechs shall be filed with the NHC within five working days after completion of the academic review and ethical review. 

(b) Required qualifications

The clinical hospitals shall (i) be tertiary-grade A hospitals; (ii) have qualified clinical study academic committees and ethics committees; (iii) have appropriate professional qualifications, facilities, equipment, management systems, personnel, research capabilities, quality assurance systems; and (iv) have stable and sufficient source of funding.

Under the Regulation, sponsors of clinical study shall be legal entities incorporated in China. This means that clinical study sponsors are no longer limited to medical institutions.  In other words, pharmaceutical companies can also act as sponsors to initiate clinical studies of New Biotechs, and as such, foreign biotech companies can set up a subsidiary in China to be a sponsor.

(c) Post-filing oversight

Clinical hospitals must keep the NHC updated on study progress. If any material safety and efficacy issues or any other uncontrollable risks emerge in a filed study, the clinical hospital shall terminate the study and report to the NHC within five working days.[6]

(d) Patient protection

Written informed consent from the subject patients is mandatory for clinical studies. Any protocol changes that may affect patient rights must be approved by the patient through separate consent letter. The informed consent letters shall be written in plain language. 

The patients should not incur any fees for participating in clinical studies. If a clinical study causes health problems to any patient, the clinical hospital shall provide timely treatment. The treatment cost shall be borne by the sponsor or by the clinical hospital that caused the health problem. Sponsors and clinical hospitals are encouraged to purchase commercial insurance for additional protection of the patients.

3. Clinical Translation and Application

Prior to promulgation of the Regulations, obtaining marketing authorization from the NMPA was the primary regulatory pathway for commercialization of the New Biotechs, and the approval regime was limited to certain pilot programs in Hainan and Guangzhou.

(a) Approval-based system

The Regulation provides for an approval based regulatory pathway for clinical translation and application of the New Biotechs. The clinical study sponsors shall obtain approval from the NHC before any clinical translation and application. Within five working days after formal acceptance, the NHC shall forward the application materials to professional institutions for technical and ethical review and assessment. The Regulation does not specify whether such professional institution should be an agency equivalent to the Center for Drug Evaluation under the NMPA (CDE) or what the timeline of the assessment of professional institutions would look like, and these details are to be addressed by subsequent implementing rules. After the professional assessment, the NHC shall render its decision within 15 working days upon receipt of the assessment results.

(b) Re-evaluation post approval[7]

In the case that an approved New Biotech causes severe adverse reactions or uncontrollable risks, the NHC shall re-evaluate the New Biotech, and the clinical application thereof shall be suspended during the re-evaluation. The NHC shall prohibit clinical application of an approved New Biotech if re-evaluation concludes that it cannot ensure safety and efficacy.

(c) Priority review

Priority review and approval by the NHC are available for the clinical translation and application of the New Biotechs that are used to treat life-threatening diseases lacking effective treatment or to address urgent public health needs.

(d) Fee charges

Under the Regulation, medical institutions are allowed to charge fees for approved clinical application, which opens up a new avenue for commercialization of the New Biotechs.

4. Recommendations

(a) Pre-filing consultation: if there are uncertainties as to the regulatory attributes of a product or technology, consult with the NHC and, if any drugs or device is involved, the NMPA, before initiating any pre-clinical or clinical studies.

(b) Due diligence on clinical hospitals: conduct thorough due diligence on partnering hospitals and establish ongoing monitoring of their qualifications and research capabilities.

(c) Drafting of clinical studies agreement: include into the clinical study agreement or collaboration agreement provisions addressing the regulatory and compliance requirements under the Regulation, such as periodic review of qualifications of hospitals as well as backup plan for potential downgrade of hospitals; informed consent implementation standards, adverse event causal determination procedures, etc.

(d) Internal compliance system: establish or refine internal SOPs for clinical study filing, informed consent, ethics compliance, risk reporting, and data privacy.

(e) Re-evaluation and continuous monitoring: implement mechanisms for post-trial follow-up and re-evaluation of technologies in line with evolving scientific and regulatory standards.

[Note]

[1]Article 3 of the Regulation.

[2]Article 21 of the Regulation.

[3]Article 55 of the Regulation.

[4]Article 8 of the Regulation.

[5]Article 9 of the Regulation.

[6]Article 25 of the Regulation.

[7]Article 37 of the Regulation.