A Guide to Japan's Regenerative Medicine Regulations

What exactly are Japan's regenerative medicine regulations (Act on the Safety of Regenerative Medicine; 再生医療安全性確保法)?

Among Asian countries, Japan is currently the only country that allows immune "cell" therapies to be legally provided outside of clinical trials. Clinical trials are also possible in Taiwan, China, and other locations with approved applications. For example, Professor Lin Cheng-long of Kaohsiung Medical University and clinical CAR-T trials in China have attracted many Taiwanese patients to travel abroad for treatment.

What we want to discuss here is: why can ordinary clinics in Japan legally use immune cell therapies? It is because Japan enacted a special law — the Act on the Safety of Regenerative Medicine — promulgated on November 27, 2013 (Heisei 25) and implemented on November 25, 2014. Relevant regulations can be found on the Ministry of Health, Labour and Welfare (MHLW) website: http://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iryou/saisei_iryou/

In simple terms: a medical institution applies to the Japanese government, and once approved, it can offer immune cell therapies and other treatments (including embryonic stem cell therapies and more — we use immune cell therapy as the example here for clarity). The basic requirement is a valid medical license, along with submission of relevant documentation. After passing review, the institution may provide these therapies.

But if a clinic has no laboratory, how are the cells cultured? It's not as simple as drawing blood, putting it in a test tube, and adding a few drops. A laboratory is needed to separate and culture and expand the cells. As mentioned, small clinics generally cannot afford to build their own laboratory or hire technical staff (even though Japanese physicians are among the high-income earners, this is still a significant expense — a lab is not just about money to build, but also requires trained laboratory personnel to operate). This gave rise to the contract cell processing industry. In Japan, two publicly listed companies — TELLA and MEDINET — specialize in providing cell manufacturing services (called "cell processing facilities," or 細胞加工施設) for medical institutions offering cell therapies. Of course, many other laboratories of various sizes also accept such contracts. This has become a mature industry in Japan, which is why you can see many clinics advertising NK cell therapy and activated lymphocyte therapy.

One important clarification: while laboratories require certification, that certification only covers the laboratory facility itself — it does not regulate which specific therapies are provided, what manufacturing processes are used, or who performs the procedures. In other words, MHLW certification of a laboratory does not constitute MHLW approval of the treatment method as medically valid. The key gatekeepers for immune cell therapies are the MHLW and the treating physicians themselves.

This brings up another important topic: self-pay medical care (自由診療, jiyuu shinryou). In Japan, medical care is divided into insurance-covered (using MHLW-approved drugs) and self-pay (which allows use of various drugs and therapies, particularly in cancer treatment where drug approvals take time). Patients urgently needing access can obtain prescriptions through self-pay arrangements. Similarly, immune cell therapy can be administered under self-pay, provided the physician thoroughly explains the treatment and the patient understands and consents. The question of liability: the physician is obligated to provide complete explanation; the patient confirms and consents. If the medical care proceeds in accordance with the physician's explanation, responsibility generally falls on the patient side — though the final determination depends on actual circumstances.

Cancer treatment in Japan without national health insurance is indeed expensive. Costs are entirely out-of-pocket unless clinical trial grants are available. Clinical trial information can be found throughout the Medical Supporter website.

We hope this gives you a better understanding of Japan's medical system and regulations so you can make more fully informed decisions.

Supplementary note: Regulatory violations in Japan's immune cell therapy field:

The Japan Society for Regenerative Medicine has issued statements on this matter. As of our publication date, the MHLW had published four cases: (1) Acty Clinic in Minato-ku, Tokyo (reportedly moved floors without updating records, ordered to suspend the specific therapy — the clinic continued other consultations and the therapy was arranged through a partner institution); (2) Sata Clinic in Minato-ku, Tokyo (used autologous stem cell intravenous injection without filing the required application); (3) Saitama Medical Clinic in Saitama (provided cord blood stem cell therapy without submitting a treatment plan); and (4) Omachi Clinic in Matsuyama City, Ehime (performed cord blood transplant therapy without filing an application).

References:

• *1 Tokyo Women's Medical University incident: https://ja.wikipedia.org/wiki/東京女子医大事件
• *2 Self-pay medical care: https://ja.wikipedia.org/wiki/自由診療

Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).

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