Industry Insight | Order No. 818 Is Coming Into Effect | Key Compliance Requirements for Cell Therapy Clinical Research

On February 24, 2026, the National Health Commission of China (NHC) released an official interpretation of Order No. 818 – Regulation on the Management of Clinical Research and Translational Application of New Biomedical Technologies (hereinafter referred to as the “Regulation”). The Regulation will officially take effect on May 1, 2026.

It establishes a full-chain regulatory framework centered on “record filing – approval – supervision.” By clarifying translational pathways, strengthening institutional responsibilities, and strictly safeguarding safety and ethical standards, the Regulation seeks to achieve a cautious balance between encouraging innovation and protecting patient safety. It also provides a clear translational pathway for emerging technologies such as cell therapy that are still evolving.

This marks a new stage for China’s biomedical technology sector—one in which compliance forms the baseline, regulation ensures stability, and innovation is released within a standardized framework.

With full lifecycle compliance requirements for clinical research now clearly defined, cell therapy—one of the most active areas of biomedical innovation—must strictly follow these regulatory boundaries to achieve sustainable development.

I. Key Compliance Requirements for Cell Therapy Clinical Research

1. Before Initiation: Passing the “Three Mandatory Gates” – Qualification, Review, and Filing

Institution Qualification

· Implementing institutions must be Class III Grade A hospitals (top-tier hospitals in China) equipped with the necessary facilities, systems, and dedicated committees.

· The project sponsor must be a legal entity within China with the capability and infrastructure for cell preparation.

· The principal investigator must hold a senior professional title in a Class III Grade A hospital and possess relevant research experience.

Preclinical Requirements

· Laboratory and animal studies must be completed before clinical research begins.

· Core data such as cell preparation processes, toxicity assessments, and antitumor activity must be clearly established.

· Direct human experimentation without adequate preclinical evidence is strictly prohibited.

Dual Review + Record Filing

· Projects must first pass both academic review and ethics committee review.

· Within 5 working days, nine categories of core materials must be submitted for record filing with the National Health Commission.

· No clinical research may begin without successful filing.

2. During Implementation: Three Parallel Lines – Subject Protection, Data Management, and Quality Control

Subject Protection

· Participants must not be charged any fees during the research phase.

· Written informed consent is mandatory. Any protocol modification requires renewed consent.

· In the event of injury, compensation must be provided in advance.

· Personal and genetic information must be strictly protected.

Data Traceability

· Research records must be accurate, complete, and truthful; falsification is strictly prohibited.

· General research data must be retained for 30 years, while genetic-related data must be preserved permanently.

· Cell-related data must be archived separately, with clear documentation of core information.

Quality Management

· Cells must be prepared in facilities that meet the required standards.

· Institutions must establish emergency response plans for adverse events.

· In the event of adverse reactions, research must be immediately suspended and reported.

· Long-term follow-up monitoring must be conducted as required.

II. Translation to Clinical Application: Approval Required Before Commercial Use

Once a cell therapy has demonstrated safety and efficacy through clinical research, institutions must apply to the National Health Commission for translational approval before clinical application.

The application must include:

· Clinical research reports

· Scope of clinical application

· Standard operating procedures for clinical use

· Risk control and management measures

Only after approval can the therapy be implemented in compliance and be eligible for clinical charges.

For life-threatening diseases lacking effective treatment options and technologies urgently needed for public health, the Regulation provides priority review pathways.

In addition, data generated during the Investigator-Initiated Trial (IIT) phase may also support the drug registration pathway. According to the 2017 Technical Guiding Principles for Research and Evaluation of Cell Therapy Products, based on principles of scientific evaluation, reducing redundant research, and benefiting patients, data from non-registered clinical studies may be accepted to varying degrees for drug registration in China—provided that:

· Clinical samples are consistent with the product submitted for registration, and

· The data generation process is authentic, complete, accurate, and traceable.

III. Compliance Insights: “Breakthroughs” and “Discipline” in the Cell Therapy Industry

The implementation of Orders 818 and 828 is gradually pushing the cell therapy industry toward a more standardized and regulated future. As the regulatory framework becomes clearer, institutions that fail to meet the required standards may face transformation or market exit, making industry differentiation inevitable.

For biotech companies, establishing a robust GMP system is becoming a fundamental requirement for participating in industry competition.

For hospitals, standardized review procedures and strict clinical implementation are critical to ensuring research quality.

For industry professionals, aligning with regulatory trends and abandoning previous gray practices will be essential for long-term career development.

The goal of rule-based regulation is not to restrict innovation, but to define the safety boundaries necessary for sustainable progress.

Only by advancing within a compliant framework can cell therapy truly benefit patients and contribute lasting value to the high-quality development of China’s biopharmaceutical industry.