China’s Order No. 818: What Foreign Biotech Companies Need to Know About IITs for Cell and Gene Therapy
China’s State Council Order No. 818 allows foreign companies to sponsor Investigator-Initiated Trials (IITs) for cell and gene therapies under a simplified filing system. Learn what this means and how to prepare.
Introduction
China is entering a new phase in clinical research governance, one that directly impacts foreign biotech companies developing cell and gene therapies (CGT).
With State Council Order No. 818 taking effect on May 1, 2026, China has, for the first time, established a national regulatory framework governing investigator‑initiated clinical trials (IITs) for cell and gene therapies, formally permitting foreign biotech companies to participate through a streamlined filing process.
While implementation details are still emerging, this regulation signals a clear policy direction: China wants innovative biomedical technologies, and it wants global participation.
What Is Order No. 818? China’s New Regulation for Cell and Gene Therapy Clinical Research
Order No. 818, officially titled Regulations on the Administration of Clinical Research and Clinical Transformation Application of New Biomedical Technologies, governs the full lifecycle of clinical research involving cutting-edge‑ biomedical technologies.
The regulation applies to therapies that:
- Operate at the cellular or molecular level
- Have not yet been approved for routine clinical use in China
- Include CAR‑T, gene editing, gene therapies, and stem cell therapies
Why Order No. 818 Is a Turning Point for Investigator‑Initiated Trials (IITs) in China
Historically, IITs in China were driven by hospitals and investigators, with inconsistent local oversight and limited involvement from foreign sponsors.
Order No. 818 changes that by:
- Creating a nationally unified IIT framework
- Replacing approval ambiguity with a filing-based compliance/transparent ‑model
- Allowing foreign invested‑ sponsors, provided they have a legally established presence in China
Key Investigator‑Initiated Trial (IIT) Requirements Under China’s Order No. 818
1. Simplified Filing Timeline
Once a study passes academic and ethics review, the hospital must file the IIT with the National Health Commission within 5 working days.
2. Eligible Clinical Sites Only
IITs under Order No. 818 may only be conducted at Grade A Tertiary Hospitals, China’s highest-level‑ medical institutions, ensuring strong clinical governance and infrastructure.
3. Sponsor Must Be a China Legal Entity
Foreign companies must establish:
- A China subsidiary, or
- A joint venture with a local partner like HiRO
This requirement is expected to be one of the main challenges for early stage biotechs‑ entering China.
Why IITs Matter to Emerging Biotech Companies
For many biotech startups, IITs are:
- The first clinical step post investment
- A way to generate early human and quality data
- An entry point to investigator network and future IND/registrational trials
China’s CGT ecosystem, with experienced investigators and large patient populations, makes IITs an increasingly attractive option and a strategic clinical drug plan.
In some regions, local governments also offer funding or Joint Venture support to attract innovative foreign biotech projects, further lowering entry barriers.
What Comes Next?
While Order No. 818 establishes the legal framework, many key implementation details, such as operational guidance and regional execution, are still being finalized by regulators. That said, sites across China are already aware of the order and are preparing to move quickly once it takes effect. To ensure you’re ready to take full advantage of this opportunity, we recommend engaging with the HiRO team now so we can support your application readiness from the start.
For now, the key takeaway is clear: China is formally opening IIT streamlined pathway to foreign CGT innovators, but preparation, local structure, and compliance strategy will be essential.
As more guidance becomes available, companies that start learning the system early will be best positioned to move quickly.
Interested in exploring whether China’s IIT pathway under Order No. 818 could be relevant to your cell or gene therapy program? Our team is actively tracking regulatory developments and working with stakeholders to better understand implementation considerations. Feel free to reach out to start a conversation with the HiRO team at info@harvestiro.com.
