Prologue: The Countdown

Only 1 days remain until May 1, 2026 — the date when the Regulations on the Administration of Clinical Research and Clinical Translation Application of New Biomedical Technologies (State Council Decree No. 818, hereinafter “Decree No. 818”) officially take effect.

As the first administrative regulation in China specifically governing the clinical research and translational application of new biomedical technologies such as stem cells and immune cells, Decree No. 818 marks the formal entry of cutting-edge fields including cell and gene therapy (CGT) into a new era of law-based regulation.

Policy Panorama: Intensive Rollout of Supporting Rules 

In late March 2026, the General Office of the National Health Commission (NHC) issued the Letter on Soliciting Opinions on the Supporting Documents for the Implementation of the Regulations on the Administration of Clinical Research and Clinical Translation Application of New Biomedical Technologies, paving the final institutional path toward the May 1 enactment. The letter enclosed two significant supporting documents:

Guiding Principles for the Delineation of New Biomedical Technologies, Drugs, and Medical Devices

Guidance Checklist for the Filing of Clinical Research on New Biomedical Technologies (First Edition)

The former details the regulatory boundaries for five categories of new technologies, while the latter provides standardized instructions for clinical research filing.

On April 19, 2026, the NHC furthered this effort by releasing the Specifications for the Approval of Clinical Translation Applications of New Biomedical Technologies (Draft for Public Comment), which clarify the approval pathway, risk classification, and timeline requirements for progressing from clinical research to translational application. Within this draft, a pivotal regulatory construct that has drawn intense industry attention was introduced: the “Same-Mechanism Principle.” Serving as the watershed between the “technology” pathway and the “drug” pathway, this principle redefines the competitive landscape of the CGT field with clear and actionable criteria.

Industry Focus: The Core Value Anchors of CROs

The industry’s focal points have now crystallized: understanding the “Same-Mechanism Principle,” accurately delineating technology pathways, precisely selecting qualified research institutions, meeting the substantive requirements of the filing system, and rapidly achieving regulatory alignment. Grounded in the real-world operational scenarios of cell therapy clinical research, this article deconstructs the core value anchors of contract research organizations (CROs) in the wake of the implementation of Decree No. 818 and its supporting regulations.

“Same-Mechanism Principle” Lands: The “Center Principle” for Technology Pathway Determination

Prior to the promulgation of Decree No. 818, the field of new biomedical technologies had long been confronted with a fundamental dilemma: Should a given cell therapy be developed via the “drug” pathway or the “technology” pathway?

Drug pathway (IND → NDA): This route imposes complete and standardized regulatory requirements across the entire spectrum of commercial-scale manufacturing and market launch, mandating robust CMC data and clinical trial evidence. It is characterized by long development timelines and high investment, yet offers a clear path to commercialization.

Technology pathway (institutional filing → translational approval): This route relies on clinical research conducted under a filing system at tertiary Grade A medical institutions, enabling cutting-edge technologies to reach clinical application more rapidly. The translational threshold is relatively lower, but market promotion is subject to regional restrictions. 

Article 3 of the Specifications for the Approval of Clinical Translational Applications of New Biomedical Technologies issued on April 19 provides the most definitive assessment framework to date. It stipulates that, to enter the scope of clinical translational application approval, a new biomedical technology must satisfy one of the following conditions:

1. It exhibits a high degree of personalization, and there is no drug utilizing the same mechanism principle that has obtained marketing authorization or initiated a confirmatory clinical trial domestically;

2. It is intended to treat a rare disease listed in the National Health Commission’s Rare Disease Catalogue, and there is no drug utilizing the same mechanism principle and targeting the same indication that has obtained marketing authorization or initiated a confirmatory clinical trial domestically.

This signifies that regulators have delineated a deliberately restrained “access radius” for the “technology” pathway. The “Same-Mechanism Principle” is not a loosely defined “similar product” concept; its evaluative dimensions encompass three tiers: mechanism of action, indication, and clinical development stage. In general, when a CGT modality is essentially identical to a marketed drug in terms of its target, mechanism of action, signaling pathway, or other such characteristics, it may be deemed to share the “same mechanism principle” even if the product form is different — thereby forfeiting eligibility for the technology pathway.

Which technologies are qualify under this pathway? 

Based on the two conditions outlined above, two principal categories of technologies satisfy the access requirements: 

1. New technologies with an exceptionally high degree of personalization that are difficult to manufacture at an industrial scale – such as customized tumor vaccines utilizing personalized neoantigens.

2. New technologies intended for the treatment of rare diseases that struggle to attract commercial investment owing to limited market returns – such as gene editing therapies for specific monogenic inherited disorders.

Although these technologies may partially draw upon known targets in their mechanisms, their highly individualized nature or orphan disease designation renders it impossible to simply categorize them as “identical in kind” to existing marketed drugs. As a result, they are afforded the opportunity to proceed with clinical translation and application via the technology pathway. Industry experts have analyzed and pointed out that under the “Same-Mechanism Principle,” marketed CAR-T therapies and CAR-NK therapies for which registrational clinical trials are already underway are largely excluded. By contrast, highly personalized TIL and Treg therapies, along with gene therapies applicable to rare diseases, will become the principal areas of interest for filing and translational approval under the technology pathway. This is also the fundamental reason why multiple leading CROs have designated TIL and gene editing therapies as priority strategic areas.

As an industry-leading integrated biomedical R&D platform, Tigermed, at the very inception of each CGT project, assists the sponsor in benchmarking against the NHC’s “Same-Mechanism Principle” determination criteria and the Guiding Principles for Delineation. By taking the degree of differentiation in target and mechanism of action, whether the indication qualifies as a rare disease, and the landscape of domestically available similar drugs as the three core dimensions, Tigermed takes the lead in completing a professional assessment of the technology pathway selection. This not only averts the compliance risks and time wastage arising from an erroneous pathway choice, but also establishes a precise strategic foundation for the subsequent execution of clinical research.

Clarifying the Boundaries: The Guiding Principles for Delineation Serve as a Supplementary Determination Tool for “Non-Drug, Non-Device” Technologies

The Specifications for the Approval of Clinical Translation Applications have resolved the core determination issue of “what may proceed to clinical translation via the technology pathway.” From another dimension, the Guiding Principles for the Delineation of New Biomedical Technologies, Drugs, and Medical Devices fully account for the distinct characteristics of different stages and adopt differentiated delineation approaches.

1. During the clinical research period: New biomedical technologies iterate rapidly, and the future pathway is marked by high uncertainty. To encourage innovation, the NHC has organized the formulation and periodic adjustment of the Guidance Checklist for the Filing of Clinical Research on New Biomedical Technologies, which serves as a reference for initiating institutions to independently determine the “new technology” attributes of their products.

2. At the time of clinical translation application: The scope of approval access is significantly “tightened,” requiring strict compliance with one of the two conditions set forth in Article 3 of the Approval Work Specifications. This embodies a regulatory hallmark of “wide entry, strict exit” — permissive during the clinical research stage and restrictive during the clinical translation application stage.

Institutional Hard Constraint: Tertiary Grade A Hospitals as the Sole Lawful Venue

Article 14 of Decree No. 818 explicitly stipulates that institutions conducting clinical research on new biomedical technologies must be tertiary Grade A medical institutions, and must concurrently possess an academic committee and an ethics committee that meet the specified requirements. The long-standing model in the cell therapy arena, in which research was affiliated with small and medium-sized hospitals or undertaken by research institutes, will be consigned to history after May 1.

The operational challenge created by this requirement is that sponsors must identify qualified tertiary Grade A hospitals and complete site selection and agreement execution before project initiation.

Many small and medium-sized innovative biopharmaceutical companies have only a weak track record of collaboration with leading tertiary Grade A hospitals, and the predicament of “having the technology but no site” is common.

This is precisely the window of opportunity for CRO enablement. By leveraging its clinical research center network covering more than 150 cities across the country and its strategic partnerships, Tigermed is able to precisely select premium centers that satisfy the tertiary Grade A qualification requirements, match them with the corresponding ethics and academic resources, and assist clients in rapidly securing research resources ahead of the new regulation's implementation, thereby driving efficient project initiation.

“Research-as-Commerce” Red Line Drawn: Unauthorized Charging Officially Terminated

Article 20 of Decree No. 818 establishes a firm financial boundary: “Clinical research sponsors and clinical research institutions shall not charge subjects any fees related to the clinical research of new biomedical technologies.” During the clinical research phase, all charges—whether for cell preparation, transportation, protocol design, special services, or research collaboration—are strictly prohibited. Violators face a fine of up to five times their illegal earnings; those conducting research without having filed for record are subject to a fine ranging from 200,000 to 1,000,000 yuan, and the principal responsible persons are prohibited from engaging in related clinical research work for five years.

This provision directly severs the widespread gray-area practice of “conducting business under the guise of research” that had long existed in the industry, thereby establishing a non-commercial compliance order for cell therapy. At the same time, the previous model in which research costs were covered through pre-collected fees has been thoroughly nullified. As a result, the professional support provided by CROs in cost budgeting, protocol design, and the allocation of research resources is becoming a critical safeguard for project implementation.

CGT Domain Expertise: From Capability to Accountability

In the face of the technology pathway determination delineated by the “Same-Mechanism Principle” and the escalation of full-chain regulatory oversight, the industry is undergoing a profound reshaping on the supply side. According to the NHC’s human genetic resources filing data, the number of clinical CRO enterprises with active filings in 2025 has dropped by 69% compared with the peak in 2021—signaling that highly specialized, comprehensively capable leading CROs are becoming the critical stabilizers underpinning the industry’s development. The implementation of the “Same-Mechanism Principle” will further accelerate the specialization-driven consolidation of the CGT field.

Tigermed has placed its CGT clinical research support capabilities at the strategic priority level:

1. It has cumulatively participated in more than 170 CGT clinical trials, spanning cutting-edge fields such as gene therapy, stem cell therapy, CAR-T, CAR-NK, TCR-T, and TIL;

2. It possesses experience in nearly 300 rare disease and ultra-rare disease studies;

3. Its teams are staffed with senior experts in medicine, operations, data management, biostatistics, regulatory affairs, and pharmacovigilance, delivering integrated services that extend from preclinical donor cell bank screening through to regulatory submission and clinical trial execution.

In terms of industry resource coordination, Tigermed maintains ongoing day-to-day engagement with industry associations and regulatory research institutions, continuously tracking the implementation dynamics and enforcement interpretations of policies such as the “Same-Mechanism Principle,” thereby ensuring that every project under the new regulation receives the most timely and precise compliance guidance.

Epilogue

With compliance as the anchor and expertise as the sail. The five-day countdown to the implementation of Decree No. 818 is drawing to a close, and the transition from the old regulatory framework to the new has entered a race-against-time phase of on-the-ground execution. The intensive rollout of supporting rules, including the “Same-Mechanism Principle,” signals that the industry’s development has pivoted from being concept-driven to being rule-driven. The core factor that will determine whether all stakeholders can successfully navigate this regulatory transformation and achieve sustainable long-term growth lies in the depth of their clinical research expertise and the maturity of their compliance infrastructure.

Compliance is not a constraint on innovation; rather, it is the prerequisite that enables innovation to advance steadily and far along a standardized trajectory. As a deeply engaged participant and a co-builder of accountability in the CGT field, Tigermed looks forward to joining forces with industry partners—pooling trust through expertise and safeguarding innovation with compliance—as we together set sail on a new voyage of high-quality development for China’s new biomedical technologies.