Closing the gap? China’s new regulation on biomedical technologies

Abstract

This paper discusses China’s State Council Order No. 818, effective May 1, 2026, which establishes a statutory framework for biomedical technologies at the cellular and molecular levels. The framework is uniquely intervention-based rather than product-based, and it addresses regulatory gaps for cell and gene therapies as well as germline interventions.

Introduction

China has long occupied a paradoxical position in the global biotechnology landscape. Home to significant scientific talent and substantial investment in biotechnology, it has also faced challenges in regulating the clinical use of unproven biomedical interventions, particularly cell-based therapies (Berger et al., 2016). Scholars and commentators have raised concerns about patients accessing experimental treatments outside any formal research framework, often at considerable personal cost and without adequate informed consent (Zarzeczny et al., 2018). The existing regulatory environment, a patchwork of overlapping rules and guidelines, lacked a single statutory framework with sufficient scope and legal force to address these interventions comprehensively (see Figure 1) (Wang and Du, 2026; Gao and Gao, 2022).

Figure 1.

Key regulatory frameworks for cell and gene therapies in China, 1993–2026, including the State Council Order No. 818 on new biomedical technologies key instruments by regulatory track, converging in the unified statutory framework of the State Council Order No. 818

Two parallel regulatory tracks are shown. The medical technology track (top) governed stem cell therapies as clinical procedures: the 2009 regulations on the Clinical Application of Medical Technologies, issued by the Ministry of Health (MOH), classified them as class III technologies (those deemed ethically problematic and requiring clinical verification) requiring MOH review and approval before clinical use; a 2012 MOH moratorium and one-year inspection campaign sought to halt unproven applications; and the 2015 stem cell clinical research management measures, issued jointly by NHFPC and CFDA, established the first dedicated stem cell clinical research framework, abolishing the class III classification and requiring research to be conducted only in class III grade A hospitals with clinical drug trial qualification, with filings made to NHFPC and CFDA. Notably, clinical use of hospital-prepared stem cell therapy after the conclusion of clinical research was not permitted under the stem cell clinical research management measures. A 2019 NHC draft regulation on management measures of clinical research and translational application of somatic cell therapy was never enacted. The drug/product track (bottom) governed cell and gene therapies as biological products under the Drug Administration Law, with successive instruments from 1993 to 2017. A jurisdictional gap existed between the two tracks, particularly for autologous and patient-specific interventions that fit neither framework clearly. State Council Order No. 818, the Regulation on the Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies, supersedes the medical technology track and integrates with the drug/product track (via Article 55 of Order No. 818), introducing a unified statutory framework that regulates by intervention rather than product. CDE, Center for Drug Evaluation, the technical review body under NMPA responsible for evaluating investigational medicines; CFDA, China Food and Drug Administration, the drug regulatory authority from 2013 to 2018, now NMPA; MOH, Ministry of Health, the national health authority until 2013, subsequently reorganized as NHFPC, then NHC; NHC, National Health Commission, the current national health authority (from 2018); NHFPC, National Health and Family Planning Commission, the national health authority from 2013 to 2018, now NHC; NMPA, National Medical Products Administration, the current drug regulatory authority (from 2018), formerly CFDA; SDA, State Drug Administration from 1998 to 2003, subsequently reorganized as SFDA (State Food and Drug Administration), then CFDA. Sources: Gao and Gao (2022); Huang (2026); State Council of the People’s Republic of China (2025). Instrument titles and descriptions are approximate English translations of Chinese-language instruments and may not be exact.

In November 2018, a Chinese scientist, He Jiankui, announced the birth of twin girls whose germline genomes were edited using CRISPR-Cas9, ostensibly to confer resistance to HIV (Li, 2020). Following widespread global condemnation, he was tried and convicted in China for illegal medical practice. The affair made clear that China had no regulations specifically governing the clinical use of technologies acting at the cellular and molecular levels of the human body (Liu et al., 2024).

A new regulation, State Council Order No. 818 on the Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies (hereinafter referred to as the regulation), seeks to address this gap (State Council of the People’s Republic of China, 2025). Signed into law on September 28, 2025, and taking effect on May 1, 2026, the regulation establishes a comprehensive statutory framework governing the full life cycle of new biomedical technologies from clinical research through formal approval for clinical use.

The statutory framework

The regulation contains seven chapters that cover general principles and scope, clinical research filing and conduct, transition to clinical application, supervision and enforcement, and legal liabilities and penalties.

The structure of the regulation is conceptually similar to clinical trial regulatory frameworks in many other jurisdictions, including Canada, South Africa, and the United States. However, unlike those frameworks, which are largely anchored to investigational products, the Chinese regulation applies to interventions regardless of whether they take the form of discrete products. In this respect, it more closely resembles the regulatory approaches in Japan and the European Union (EU), both of which have recognized pathways addressing interventions rather than products alone—Japan, through its Act on the Safety of Regenerative Medicine (Tobita et al., 2016), and the EU, through the hospital exemption under the Advanced Therapy Medicinal Products (ATMPs) Regulation (Sánchez-Guijo et al., 2023).

Intervention-based regulation

The regulation’s intervention-based approach is evident in the definition of “new biomedical technologies.” Article 3 defines the term as “professional medical means and measures that, for the purpose of making judgments on health status or preventing and treating diseases or promoting health, employ biological principles, act at the cellular or molecular level of the human body, and have not yet been applied clinically within” China.

The phrase “professional medical means and measures” is not the language of conventional health products regulation, which typically focuses on drugs, devices, biologics, and medicinal products. Rather, “means and measures” is broad enough to capture interventions that do not fit neatly into any existing product category, such as autologous cell therapies, personalized gene edits, patient-specific immune interventions, and similar technologies customized for an individual patient that do not exist as discrete manufactured products in the conventional regulatory sense.

This choice of language matters because one of the most persistent debates in the regulation of advanced therapies concerns the distinction between clinical innovation, which typically involves a clinician applying a novel approach to a specific patient, and regulated health products subject to pre-market approval requirements (Munsie and Pera, 2014). This distinction has been used to support arguments that administering a patient’s own cells, or cells customized for that patient, constitutes medical practice rather than use of a regulated product, and therefore, falls outside the jurisdiction of health product regulators.

China’s regulation addresses this by regulating the intervention rather than the product. Rather than asking whether the activity involves a regulated product, it asks whether the activity employs biological principles at the cellular or molecular level and has not yet been applied clinically in China. If both conditions are met, the regulation applies, regardless of whether what is being administered takes the form of a manufactured product or a tailored clinical procedure.

However, the regulation does not itself specify how broadly or narrowly the scope of a single intervention must be defined for filing or approval purposes. It is not yet clear, for instance, whether a gene therapy approach must be filed separately for each target condition, or whether a single filing could cover a platform approach applied across multiple conditions using variations of the same method. This, and other similar interpretive questions, will need to be determined through the guidelines to be developed under articles 31 and 55, and will shape how the regulation operates.

Regardless, interventions such as administering customized chimeric antigen receptor (CAR)-T cell therapies, infusing autologous stem cells, or manipulating a human embryo before implantation would most likely fall within the regulation’s scope. Claims that such interventions fall outside the regulatory framework, because what is being administered is not a regulated product, would likely fail. China’s approach, therefore, represents a notable attempt to resolve an ambiguity that has resisted resolution in other regulatory systems.

The regulatory pathway

The regulation features a two-stage pathway that a new biomedical technology must travel before it can be used clinically (see Figure 2). Both stages are distinct and separately governed. The first is the “clinical research” (临床研究) stage, and the second is the “clinical translational application” (临床转化应用) stage. These terms are not synonymous in the regulation. “Clinical translational application” is used as a term of art to refer specifically to the formal authorization process by which a technology that has completed clinical research may be approved for broader clinical use. It is not used in the general sense of translational research as that phrase is often understood in the scientific literature.

Figure 2.

The two-stage regulatory pathway under the State Council Order No. 818

Stage 1 (clinical research) governs the testing of new biomedical technologies in human participants and proceeds by filing with the National Health Commission (NHC) following institutional academic and ethics review. Stage 2 (clinical translational application) is the formal NHC review and approval process required before a technology that has completed clinical research may be used in clinical settings. The two stages are distinct and separately governed; “clinical translational application” is a term of art in the regulation and is not synonymous with the general concept of translational research. Two deviation pathways are shown: a mandatory suspension or termination pathway that may be triggered at any point during stage 1 (Articles 17 and 25) and an emergency use pathway under Article 36 permitting limited clinical use of a stage 1 technology in defined public health emergencies. The evidentiary standards governing the stage 2 NHC assessment decision are to be specified in guidelines yet to be issued by the NHC.

The clinical research stage involves testing a new biomedical technology in human participants. The regulation stipulates that non-clinical research, comprising laboratory studies and animal experiments, must be completed and must demonstrate safety and efficacy before clinical research begins. Once this precondition is satisfied, clinical research may proceed only through institutions meeting specific qualifying criteria. The institution must be a class III grade A medical institution, the highest tier in China’s hospital classification system. It must have both an academic committee and an ethics committee that independently review and approve the proposed research. The project leader must hold a senior professional title and a practicing physician qualification, and the project must have stable and sufficient funding.

One question the regulation does not resolve explicitly is what happens if an institution loses its qualifying status during an ongoing project, for example, if a hospital is reclassified from class III grade A to a lower tier. The National Health Commission (NHC), as the responsible regulator, could intervene in such circumstances, but no express mechanism is stipulated in the regulation. This is an operational gap that implementation guidance will need to address.

Following approval by the academic and ethics committees, the research must be filed with the NHC within five working days. The filing must include the research protocol, non-clinical research reports, informed consent templates, risk management plans, and ethics review opinions, among other materials. The NHC publishes all filed research publicly and conducts ongoing assessment of filed projects, with authority to require suspension or termination where technical or ethical risks emerge.

Under Article 57, clinical research already underway before May 1, 2026, may continue in accordance with its existing protocol, but the institution must file with the NHC within 1 month of the regulation coming into force.

The regulation sets out specific requirements for informed consent in Article 19. Clinical research institutions must obtain written consent from research participants, or from their guardians where participants lack or have limited civil capacity. Consent must be obtained without deceit, coercion, or inducement, and participants must be informed of the research purpose, protocol, and potential risks in a manner they can understand. Where a subsequent protocol change may affect participants’ rights or interests, re-consent is required. These provisions potentially address concerns about informed consent in experimental cell therapy settings in China, including governance failures that have allowed such treatments to proceed without adequate patient consent (Zhang, 2017).

On data protection, Article 28 requires all institutions involved in clinical research to protect participants’ personal privacy and personal information in accordance with applicable law, and Article 22 requires that records and original materials be retained for thirty years from the conclusion of research, or permanently where the research involves offspring. The regulation does not itself establish a comprehensive data governance regime but relies on China’s broader personal information and data protection legislation for that purpose.

In the clinical translational application stage, projects that have completed clinical research must apply to the NHC for clinical use authorization. Under Article 31, the NHC must refer the application to designated professional institutions for technical and ethical assessments and must issue a decision within fifteen working days of receiving the assessment opinions. Approval is granted where clinical research has demonstrated safety and efficacy and ethical principles are satisfied and rejections must be issued in writing with reasons. Article 31 further authorizes the NHC to develop “working specifications” to guide the review of clinical translational applications. What level and type of evidence will be required to satisfy the safety and efficacy threshold and how the NHC-appointed assessors will weigh that evidence remains an open question as guidelines are yet to be developed.

In addition to the two-stage pathway, the regulation provides for priority review and emergency use. Article 32 permits the NHC to give priority review and approval to technologies that treat diseases that seriously endanger life and currently lack effective treatments as well as to those urgently needed in public health contexts. Article 36 further allows the NHC to authorize emergency use of technologies still undergoing clinical research during a major public health emergency, within a defined scope and time limit.

Following the granting of clinical use authorization, the regulation establishes a continuing oversight mechanism under Article 37. Where scientific understanding of an approved technology’s safety or efficacy changes, where serious adverse reactions or uncontrollable risks arise during clinical use, or where other circumstances prescribed by the NHC arise, the NHC must suspend clinical use and conduct a re-assessment. If re-assessment cannot confirm safety and efficacy, the NHC must prohibit further clinical use of the technology.

The He Jiankui affair and the germline provisions

Article 8 defines clinical research to include operations on human germ cells, zygotes, or embryos subsequently implanted into the human body to develop. This provision directly addresses the kind of intervention He Jiankui carried out. Article 9 prohibits clinical research on technologies that are expressly prohibited by law or that involve “major ethical issues.” This phrase is not defined in the regulation, but given the ethical controversy surrounding He’s experiment, it would likely have been caught by this provision had the regulation been in place at the time.

By bringing germline interventions within the scope of regulated clinical research, China signals recognition of the gravity of the He affair. Leaving the meaning of “major ethical issues” undefined seems like a deliberate design choice that allows for ethical deliberation in cases where a technology has not been expressly banned, while also preserving the capacity to prohibit interventions that attract near-universal condemnation. The drafters appear to have recognized that a rigid statutory definition risks foreclosing legitimate scientific and ethical deliberation in future cases that may be less clear-cut.

The meaning of “major ethical issues” will inevitably be tested by specific technologies as the regulation is applied. For example, mitochondrial replacement therapy (MRT), which involves the manipulation of a human egg or zygote to replace mitochondrial DNA and subsequent procreative implantation, would appear to fall within the scope of Article 8(3) as an operation on human germ cells or zygotes implanted into the human body to develop. Whether it would then be prohibited under Article 9 as involving a “major ethical issue” is less clear. MRT has attracted significant ethical controversy because it involves modification of heritable germline mitochondrial DNA and raises questions about genetic identity where a child carries genetic material from three individuals. Critics also point to the risk of normalizing germline intervention in ways that could extend to non-therapeutic uses. At the same time, its use to reduce the risk of transmitting serious mitochondrial disease is widely regarded as distinct from germline editing for enhancement or other non-therapeutic purposes, and countries including the United Kingdom and Australia have authorized it under specific conditions (Castro, 2016). The deliberate decision to leave “major ethical issues” undefined in the regulation suggests that the permissibility of technologies such as MRT would likely require case-by-case deliberation by the NHC and its designated ethics assessors, rather than resolution by the text of the regulation itself. MRT is a good example of how the undefined standard could cut both ways, allowing for flexibility while also creating uncertainty.

New biomedical technologies versus drug/device regulation

Article 55 clarifies how the regulation relates to drug and medical device regulation. Where clinical trials are conducted specifically to develop a drug or medical device, those trials remain governed by existing drug and medical device laws and regulations. The NHC and the National Medical Products Administration (which oversees drugs and medical devices) are directed to jointly develop guidelines clarifying which framework applies as science and practice evolve. Under Article 55, a cellular intervention might fall under the regulation when used in a hospital-based research context and under drug regulations when pursued for commercial marketing authorization. The two frameworks appear as intended to be complementary rather than competing, covering different phases and purposes of development.

International comparators

The regulation is notable in the context of international approaches to the same regulatory challenges. The United States regulates cell and gene therapies primarily through the FDA’s biologics framework, which applies to products. However, regulatory uncertainty persists in relation to certain autologous cell-based treatments, and there have been legal disputes over whether such interventions fall within the FDA’s authority or within exceptions for surgical procedures and the practice of medicine (Chirba, 2020). The EU’s ATMP Regulation addresses similar territory through the hospital exemption, which allows member state hospitals to prepare ATMPs for individual patients without full marketing authorization, but creates a category of activity outside the full authorization pathway. Japan maintains both a conditional approval pathway for regenerative medicine products and a separate framework for their clinical use, with the boundary between them subject to ongoing interpretation. Canada regulates autologous cell therapy products as drugs, but this has not eased uncertainties regarding their regulatory classification (Health Canada, 2020).

None of these frameworks uses the definitional approach China has adopted. Unlike product-based frameworks, the scope and application of the regulation do not depend on whether the intervention takes the form of a manufactured product. Whether this approach proves more effective in practice than product-based frameworks remains to be seen, but as a regulatory design choice, it charts a different course that policymakers elsewhere would do well to consider.

One further dimension may be of particular relevance to countries in the Global South, many of which are grappling with the same challenges: the proliferation of unproven cell-based interventions, the limitations of product-based frameworks in capturing autologous therapies, and the absence of a comprehensive statutory basis for governing clinical research in this field. China’s intervention-based approach may offer a model more readily adaptable to those contexts than the product-based frameworks developed in high-income jurisdictions, which presuppose regulatory infrastructure, institutional capacity, and other resources that may not be evenly distributed globally. An intervention-based framework attaches regulatory requirements to clinical interventions, whether at the research or translational stages, rather than to product classification, which may be more workable where product regulatory pathways are less developed. China’s approach does, however, presuppose an institutional actor like the NHC with authority and capacity to oversee clinical practice directly, making it most transferable to systems with an equivalent national clinical regulator or political will to establish one. Regulatory transfer is rarely straightforward, but the regulation’s structural approach is worth attention from policymakers in any jurisdiction where the governance of unproven biomedical interventions remains a pressing matter.

Potential gaps and matters arising

One area the regulation does not address is research transparency and the public reporting of outcomes. Article 26 requires clinical research institutions to report results and recommendations to the NHC upon conclusion of research, but this is a regulatory reporting obligation rather than a requirement to publish findings, including negative results. Whether the NHC’s practice of publishing filed research publicly, required under Article 17, will extend to outcomes data as projects conclude is unclear. The broader value of the regulation’s framework to the scientific community will depend, in part, on the accessibility of results generated under it.

The regulation’s intervention-based approach also raises questions about how intellectual property (IP) will be managed. IP protection in most jurisdictions is structured around defined inventions or product formulations rather than clinical interventions. Although health products and clinical governance frameworks do not generally address IP, the regulation’s focus on interventions rather than products nonetheless raises the question of whether this approach creates additional complexity for IP protection. This is a matter that other legal and policy instruments will need to resolve, and one that could affect the commercial development of technologies the regulation governs.

Conclusion

State Council Order No. 818 is a comprehensive piece of legislation. It addresses the full development pipeline for new biomedical technologies, establishes clear institutional and procedural requirements for clinical research, and creates a formal approval pathway for clinical use. The most notable feature is the decision to regulate the intervention rather than the product. This approach has the potential to address regulatory gaps that product-based frameworks have struggled with, particularly at the autologous and patient-specific end of cell and gene therapy. Whether it successfully does so in practice will depend on the implementation, the quality of boundary guidance yet to be developed, and the consistency of enforcement.

Acknowledgments

Preparation of this manuscript was supported by a Government of Canada’s New Frontiers in Research Fund—Transformation Stream (NFRFT-2022-00327) grant. The author is grateful to Li Du, Zhangyu Wang, and the anonymous peer reviewers for comments on earlier drafts of this paper.

Author contributions

U.O. is the sole author of this work and is responsible for all aspects of the manuscript, including conceptualization, research, legal and policy analysis, writing, editing, and final approval.

Declaration of interests

The author has no interests to declare.