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Implementation of Decree No. 818: Filing Is Not a Green Light for Clinical Application, Technology Translation Still Needs Regulatory Definition

May 01,2026

The Regulations on the Administration of Clinical Research and Translational Application of New Biomedical Technologies (Decree No. 818, hereinafter referred to as the Regulations), which has attracted widespread attention from the pharmaceutical industry, officially came into force on May 1.

The promulgation of this administrative regulation marks that the clinical research and translational application of cutting-edge technologies such as stem cells, immune cell therapy and gene therapy are now governed by clear laws and regulations. Nevertheless, industry questions remain unanswered: Does the filing-based administration mean relaxed supervision? Can the technology translation path genuinely bypass the lengthy cycle of drug registration?

Recently, Wu Zhaohui, Vice Chairman of the China Pharmaceutical Biotechnology Association, shared his insights on the legislative background, core institutional design, the debate over the "dual-track system", and practical recommendations at a public event.

01、Legislative Background: Industry Chaos and Regulatory Vacancy

Since the release of the Regulations, the industry has put forward diverse and even conflicting interpretations and speculations, which Wu Zhaohui sorted out in his report.

The first is the technology-driven development theory. Some hold that the Regulations are formulated to vigorously advance new biomedical technologies and accelerate their transformation from academic research to clinical application.

The second is the pathway breakthrough theory. Although clinical research on stem cells is permitted, achievements cannot be directly translated into clinical use and still need to go through the drug registration procedure. It is speculated that the Regulations aim to break the bottleneck of "research allowed but application restricted".

The third is the cost dilemma solution theory. Cell and Gene Therapy (CGT) products face long registration cycles and exorbitant costs under the drug registration pathway; a single CAR-T therapy can cost nearly one million RMB, placing a heavy burden on patients. It is expected that regulating such technologies under the medical technology framework will lower costs and resolve the cost predicament under drug registration rules.

The fourth is the medical institution revenue-generation theory. Some argue the Regulations are designed to create new revenue channels for medical institutions struggling with operational pressures. Except for a few large general hospitals, many medical institutions are operating at a loss or on the verge of deficit, providing realistic grounds for such speculation.

Wu Zhaohui pointed out that the real legislative origin can be traced back to the gene-edited baby incident in Shenzhen in 2018.

On November 26 that year, news of "the world’s first gene-edited babies resistant to AIDS born in China" triggered an immediate public outcry and exerted extremely negative repercussions at home and abroad.

As responded by officials from the Ministry of Justice and the National Health Commission in a press briefing in October 2025, the incident exposed serious loopholes in China’s ethical supervision of biomedical research. During subsequent investigations and disposal, regulators found a lack of legal basis to impose penalties on such violations.

The Measures for Ethical Review of Biomedical Research Involving Human Subjects issued by the former National Health and Family Planning Commission in 2016 set relevant requirements yet imposed mild penalties, mostly rectification orders and warnings, which failed to form effective deterrence.

Meanwhile, technological advances have also forced the improvement of relevant laws.

According to officials from the Ministry of Justice and the National Health Commission, the formulation of the Regulations is driven by the booming demand for biomedical innovation in China. Research on cell and gene therapy, xenotransplantation, invasive brain-computer interfaces and other emerging technologies is increasingly carried out in medical institutions, while supervision of these technologies has long lacked legal basis.

Previously, only stem cells and somatic cells were regulated by departmental rules under the health authority. Other fields including gene therapy, cell derivatives (exosomes, vesicles), xenotransplantation and brain-computer interfaces were in a regulatory vacuum. Existing departmental rules were limited in binding force, allowing regulators merely to suspend non-compliant projects.

It was the predicament of inadequate regulation and insufficient penalty provisions that prompted the introduction of this administrative regulation.

Article 1 of Chapter One clearly states the legislative purpose: To standardize the clinical research and translational application of new biomedical technologies, and promote progress and innovation in medical science and technology. Article 4 further clarifies the guiding principles: putting people’s health first, adhering to innovation-driven development, and balancing development with safety.

As outlined in the press briefing by the Ministry of Justice and the National Health Commission, the formulation follows three general principles:

Prioritize people’s health, focus on risk prevention and safety guarantee;
Support clinical research and translational application of new biomedical technologies to drive innovative development;
Consolidate the primary responsibility of institutions, clarify the obligations of research initiators and implementing institutions, and strengthen accountability.

The core objective of the Regulations is therefore clear: standardization first, innovation second, with safety and medical ethics as inviolable bottom lines.

02、Core Institutional Design

Article 3 of the Regulations defines new biomedical technologies as: Professional medical approaches and measures that adopt biological principles to act on human cellular and molecular levels for health assessment, disease prevention, treatment and health promotion, and have not yet been clinically applied within China.

Wu Zhaohui noted that this legal concept is exclusively created by the Regulations. No statutory or professional definition of "new biomedical technologies" existed either domestically or internationally prior to its issuance.

In essence, the term is a tailor-made regulatory scope covering (but not limited to) cell therapy, gene therapy, tissue engineering, invasive brain-computer interfaces, and xenotransplantation.

Articles 4 and 5 stipulate the basic principles for conducting clinical research: prioritizing people’s health, possessing scientific rationales, abiding by laws and regulations, avoiding harm to human health, complying with ethical norms, respecting subjects’ will and safeguarding their dignity.

The Regulations adopts a filing-based administration for clinical research on new biomedical technologies. This mechanism draws on nearly a decade of practical experience from the Trial Measures for the Administration of Clinical Research on Stem Cells issued in 2015, whose effective supervision has given regulators confidence to extend the filing system to new technologies.

Prior to launching clinical research, the following procedures must be completed:

Conduct non-clinical research including laboratory and animal experiments in accordance with the law;
Verify safety and efficacy through non-clinical studies;
Pass academic and ethical reviews by the research institution.

After approval, the institution shall submit filing documents to the national health authority within 5 working days.

In addition, Article 11 sets strict access thresholds: the institution must be a Grade A Tertiary Hospital; have qualified academic and ethical committees; possess required qualifications, premises, facilities, professional personnel and research capacity; establish management systems for quality safety and subject rights protection; and maintain stable and sufficient research funding.

For translational clinical application, the core institutional arrangement is the approval system.

Qualified new biomedical technologies proven safe, effective and ethically sound through clinical research may be applied clinically upon approval by the national health authority. The approval process is specified as follows: the national health authority shall transfer application documents to professional institutions for technical and ethical evaluation within 5 working days upon acceptance, and make a final decision within 15 working days after receiving the evaluation opinions.

Wu Zhaohui emphasized a widespread industry misunderstanding: Filing only permits clinical research, not immediate clinical application. Translational use requires separate official approval. Upon approval, the national health authority will release unified standards for qualified medical institutions, professional personnel and clinical operational specifications.

03、Procedural Improvements, Not a Loose Regulatory Path

The most prominent procedural optimization of the Regulations lies in the simplification and unification of the filing process.

Two key changes have been made:

The provincial health authority review link is abolished; institutions may directly submit filing applications to the national health authority after internal academic and ethical reviews;
The concept of clinical research initiating institution is introduced, allowing non-medical entities such as enterprises and research institutes to initiate and cooperate with medical institutions in clinical research.

Article 12 stipulates that initiating institutions and implementing institutions shall sign written agreements to define rights and obligations and jointly formulate research protocols. Medical institutions are also permitted to launch clinical research independently.

To a certain extent, this clause provides a compliant platform for biopharmaceutical enterprises with mature technologies but no prior clinical research achievements to cooperate equally with medical institutions.

Moreover, the Regulations greatly optimizes the filing mechanism for multi-center clinical trials.

Under the previous stem cell research rules, each participating institution in a multi-center trial needed to file separately, resulting in extremely low efficiency. Some projects with over ten participating institutions even spent two to three years completing filing. Under the new rules, only the leading institution needs to submit a single filing for the entire multi-center trial.

Wu Zhaohui explained that the Regulations does not lay down overly detailed requirements for academic and ethical committees. Given the wide coverage of new biomedical technologies — ranging from CGT and xenotransplantation to brain-computer interfaces — technologies vary drastically in risk profiles, making unified administrative standards impractical. Detailed specifications will be issued in subsequent technical guidelines for individual sectors.

It is critical to clarify that filing does not mean exemption from review.

Many misinterpret filing as mere notification. However, Articles 15 to 17 clearly mandate that the National Health Commission will organize professional institutions to evaluate filed projects and suspend or terminate unqualified ones.

The system essentially adopts a dual regulatory mechanism of pre-filing plus dynamic post-evaluation. The filing system does not represent deregulation; instead, it safeguards safety through regulatory innovation and shifts the supervision model from strict entry with lenient oversight to lenient entry, strict whole-process supervision.

The Regulations greatly improves administrative efficiency for translational approval: the whole administrative procedure takes only 20 working days in total.

Nevertheless, as Wu Zhaohui pointed out, the Regulation sets no statutory time limit for technical evaluation by professional institutions, which may take one month or even one year. This leaves applicants unable to accurately predict the timeline and capital costs of translational application.

A major distinction from previous departmental rules lies in the explicit specification of legal liabilities for violations.

Stringent quantified penalties are imposed on violations such as conducting clinical application without filing or approval, covering medical institutions, leading officials and relevant medical staff. Such provisions are absent in previous rules including the Trial Measures for the Administration of Clinical Research on Stem Cells, substantially enhancing legal deterrence.

04、The Debate over the "Dual-Track System"

Whether a dual-track system truly exists is the most concerning issue in the industry.

It is widely acknowledged that cell therapy products such as CAR-T face a lengthy (5–10 years) and costly (hundreds of millions to billions of RMB) drug registration pathway. If regulated as medical procedures, both approval time and costs could be drastically reduced.

Therefore, many enterprises and medical institutions hope to adopt a dual strategy: launching paid clinical application via the Regulations first while advancing IND applications, ultimately achieving dual listing as both a medical technology and a pharmaceutical product.

Wu Zhaohui holds a different view: The so-called dual-track system is not two parallel optional pathways, but a clear boundary demarcation. Enterprises cannot freely choose either route; instead, regulators will define whether a technology falls under pharmaceuticals or medical procedures.

He cited Article 55 of the Regulations: The national health authority shall, jointly with the national drug regulatory authority, formulate and adjust guidelines for distinguishing new biomedical technologies from pharmaceuticals and medical devices. This provision itself negates the existence of an optional dual-track system: if enterprises could choose freely, there would be no need for official demarcation guidelines.

In short, it is regulators, not enterprises, that determine whether a technology is categorized as a drug or a medical procedure.

The Regulations does not specify grading criteria for translation and application. Unresolved questions remain: Is Phase I clinical trial sufficient for translation application, or are Phase II and Phase III mandatory? Are randomized controlled trials required, or can limited case reports suffice? No official clarification has been released to date.

Citing the draft supporting rules, Wu Zhaohui noted that only technologies meeting two prerequisites are eligible for the medical technology translation pathway:

Highly personalized technologies incompatible with conventional pharmaceutical registration models;
Rare disease therapies with no ongoing drug registration applications by any enterprise.

05、Industry Value of the New Regulation

Despite high access thresholds for translational application, the Regulations delivers profound value to the industry:

First, clinical research is now legally grounded. It provides legal authorization for researchers and statutory basis for ethical committees.

Since May 1, all clinical research on new biomedical technologies has obtained clear legal basis. Previously, ethical committees of major hospitals often struggled to judge the legitimacy of new technology research. The Regulations resolves this issue by establishing unified compliance standards and eliminating administrative risks of undefined regulation.

Second, translational application has standardized procedures, clarifying a regulatory pathway for innovative technologies falling into the grey area between pharmaceuticals and medical procedures.

Wu Zhaohui cited xenotransplantation (e.g., pig-to-human organ transplantation) as an example: pigs are regulated by the agricultural authority, while clinical transplantation involves health and drug regulators, yet the technology differs fundamentally from existing drugs, devices and organ transplantation. Such technologies once had no clear regulatory authority. The Regulations now provides a legal pathway for such cross-border innovations.

Third, introduction of an emergency application mechanism.

The Regulations allows emergency use of technologies still in clinical research under major public health emergencies (similar to the COVID-19 pandemic), following rigorous review and approval. Drawing on the emergency use mechanism for vaccines under the Vaccine Administration Law, it fills the policy gap in emergency application of stem cell and somatic cell therapies.

Fourth, standardizing industrial development and optimizing the investment environment.

Prior to the Regulations, the industry suffered from a bad money driving out good phenomenon. Enterprises investing heavily in formal IND pathways faced weaker commercial returns than unregulated low-cost products that bypassed rigorous clinical trials and entered the market directly, distorting investment expectations and damaging the industrial ecosystem. The Regulations brings all new biomedical technologies into standardized supervision, eliminating grey market space from the source.

06、Practical Recommendations for the Industry

Wu Zhaohui reminded industry practitioners to strengthen legal awareness.

The Regulations imposes severe legal liabilities, including revocation of medical institution practice licenses, revocation of medical practitioners’ qualifications, personal fines and lifetime industry bans for responsible personnel.

In addition, prior to launching any clinical research, institutions and enterprises must evaluate whether their technology is eligible for the medical technology translation pathway.

For standardized, mass-producible technologies with clear druggable properties and feasible drug registration pathways, R&D should follow pharmaceutical or medical device registration routes immediately after proof-of-concept.

Otherwise, investing time, capital and patient resources in large-scale randomized controlled trials only to be instructed by regulators to switch to drug registration will result in irreversible losses of time and opportunity costs.

For highly personalized, non-standardizable technologies (such as individualized gene editing targeting specific gene mutations) applied to rare diseases with limited commercial incentives, researchers may adopt confirmative clinical trial designs to pave the way for future translational approval.

Even so, rigorous clinical trial design is indispensable. The Regulations only sets general principles of safety and efficacy without detailed grading standards. The most prudent approach is to communicate proactively with regulators at the project initiation stage for professional guidance.

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