How stem cell regulation differs between China and Japan: start with the three legal routes

In this article

01Why you can’t just compare “where it can be done”
02Japan: three routes in parallel
03China: two routes—drugs and clinical research
04What this means for patients
05Four questions to ask when verifying
06Common questions

Short answer

The biggest difference is whether a “register, then provide self-pay treatment” route exists. In Japan, once a medical institution’s treatment plan has been reviewed by a Certified Committee for Regenerative Medicine and submitted to the Ministry of Health, Labour and Welfare (MHLW) under the Act on the Safety of Regenerative Medicine, the institution can provide self-pay treatment using autologous stem cells and similar cells, and the plan number can be looked up on the official website. In China, technologies such as stem cells are either approved for marketing as drugs by the National Medical Products Administration (NMPA) or conducted as registered clinical studies, and clinical studies may not charge participants related fees. The Regulations on the Clinical Research and Clinical Translational Application of New Biomedical Technologies, effective May 1, 2026, continue this principle; research results require approval by the health authority under the State Council before entering clinical application.

Japan: Act on the Safety of Regenerative Medicine: The Act on the Safety of Regenerative Medicine took effect in November 2014; the revised Act took effect on May 31, 2025, bringing in vivo gene therapy and similar treatments under its scope.
Japan: self-pay treatment: Risk-based Classes I–III; after review by a Certified Committee for Regenerative Medicine, plans are submitted to the MHLW (Class I also requires national review); plans are published on e-Regenerative Medicine.
Japan: product approval: “Regenerative medical products, etc.” under the Pharmaceuticals and Medical Devices Act (PMD Act) may obtain conditional and time-limited approval, such as two iPS cell products approved in March 2026.
China: drug route: Cell therapy products are regulated as drugs and approved by the National Medical Products Administration (NMPA). On January 2, 2025, conditional approval was granted to amimestrocel injection, the first approved stem cell therapy in China.
China: clinical research: The 2015 Administrative Measures for Clinical Research on Stem Cells (Trial) require institutions and projects to register, prohibit charging research-related fees to subjects, and do not allow research to directly enter clinical application after completion.
China: new regulations: State Council Order No. 818, the Regulations on the Clinical Research and Clinical Translational Application of New Biomedical Technologies, effective May 1, 2026; clinical research may not charge subjects, and clinical translational application requires approval by the health authority under the State Council.

Why you can’t just compare “where it can be done”

The words “stem cell therapy” can refer to three completely different things: approved marketed products (drugs), clinical research still under evaluation, and medical technologies provided by medical institutions in accordance with regulations. Their approving authorities, whether fees can be charged, and who is responsible if problems arise all differ.

So when comparing across borders, first ask “Which route does this treatment fall under locally?”, then discuss price and itinerary. Simply saying “not allowed in China but allowed in Japan” overlooks the conditions behind it.

Japan: three routes in parallel

First is the product route: companies apply under the PMD Act for approval of “regenerative medical products, etc.” After approval, they are used per indications, and some may be covered by public health insurance. Second is clinical research and clinical trials to verify safety and efficacy in humans. Third is treatment provided by medical institutions after submitting a “regenerative medicine provision plan” under the Act on the Safety of Regenerative Medicine; most are self-pay.

The third is what Chinese-speaking users most often encounter as “going to Japan for stem cells.” Its premise is that the plan has been reviewed by a Certified Committee for Regenerative Medicine and submitted to the MHLW, and that the cells are processed at a facility registered with the authorities. Registration indicates the treatment has entered statutory oversight; it is not certification of efficacy.

China: two routes—drugs and clinical research

Cell therapy products can be submitted for approval as drugs and approved by the NMPA, such as CAR-T products and amimestrocel injection, which was conditionally approved in January 2025 for certain cases of acute graft-versus-host disease.

Beyond drugs, new technologies such as stem cells are mainly conducted as clinical research. The 2015 Administrative Measures for Clinical Research on Stem Cells (Trial) require registering institutions and research projects, and prohibit charging research-related fees to subjects. The new regulations effective May 1, 2026 bring clinical research and clinical translational application of new biomedical technologies under unified management and likewise prohibit charging subjects for clinical research.

What this means for patients

When inquiring in Japan about self-pay treatments: ask the institution for the regenerative medicine provision plan number, and verify the institution name, treatment name, and class yourself in the e-Regenerative Medicine public list.
When you encounter paid “stem cell therapy” in China: first clarify whether it is a marketed drug or clinical research; clinical research may not charge subjects research-related fees.
Same in both countries: registration or approval only indicates procedural compliance. Whether it suits you and what effect to expect must be assessed by a doctor together with your examinations.
After treatment in Japan and returning to China: keep the Japanese records of treatment, cell processing information, and medications, and give them to your doctor in China at follow-up visits.

Four questions to ask when verifying

In the local system, is this treatment a drug, clinical research, or a medical technology provided by a medical institution?
Which authority approves or accepts it? Is there a publicly searchable number?
How are fees charged? Do clinical studies charge subjects?
If adverse reactions occur, who is responsible for follow-up and handling?

Common questions

Can stem cell treatment be done as self-pay in China?

Marketed stem cell drugs are used in hospitals according to approved indications. Other stem cell projects are generally conducted as clinical research, and clinical research may not charge subjects research-related fees. When you encounter paid “stem cell therapy,” first clarify which route it follows.

Does registration in Japan equal national certification of effectiveness?

No. Registration indicates the treatment plan has been reviewed by a Certified Committee for Regenerative Medicine and submitted to the MHLW. It is a requirement for safety and procedure, and does not mean efficacy is certified.

Do the new regulations taking effect in May 2026 affect going to Japan for treatment?

The regulations govern clinical research and clinical translational application of new biomedical technologies conducted within China; medical care in Japan is governed by Japanese law. They reflect how similar technologies are managed in China and can be used as a reference for comparison.

After treatment in Japan, can doctors in China continue follow-up?

Whether to continue follow-up is up to the doctor in China. Bringing complete Japanese treatment records, cell processing information, and medication details will make follow-up smoother.