Yes, NK Killer Cell therapies are legal in Japan according to the Act on the Safety of Regenerative Medicine (ASRM).
However, this doesn’t mean they have been “approved”, they are still experimental.
We break down the full legal status & what it actually means for people looking into NK Killer Cells in Japan.
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All legal data is updated as of December 2025. Legal information is obtained directly from official government sources (Japan’s MHLW) and is reviewed monthly.
Have NK Killer Cells been approved in Japan?
No, NK Killer Cells have not been officially approved, but treatment is allowed as an experimental option.
- Japan’s regulatory framework, under the Pharmaceuticals and Medical Devices Act, requires any cell‑based therapy intended for general clinical use to receive marketing approval.
- No NK cell therapy is on the official list of approved regenerative medical products as of 2025.
- All NK cell uses in Japan are experimental or unapproved regenerative medicine provided under the Act on the Safety of Regenerative Medicine, not as formally approved therapies .
How do Clinics get approved to perform NK Killer Cell Therapy in Japan
According to Japan’s MLHW’s submission plan, clinics have to design a plan & get it approved to be able to perform treatment. Here are the steps in more detail:
1
Design a Regenerative Medicine Plan
Design a Regenerative Medicine Plan
The clinic prepares a detailed treatment protocol (e.g. how NK cells will be collected, cultured, and infused; target disease; safety measures; consent procedures)
This includes classifying the therapy under Class I, II, or III risk under the Act on the Safety of Regenerative Medicine (ASRM)
2
Submit for Review to a Certified Committee
Submit for Review to a Certified Committee
The plan must be reviewed by a Certified Special Committee for Regenerative Medicine (CSCRM) if it’s Class I or II (NK cell therapies typically fall here)
The committee evaluates safety, scientific rationale, and ethical considerations
3
Notify or Obtain Approval from MHLW
Notify or Obtain Approval from MHLW
If the therapy is Class II (e.g., autologous NK cells), the clinic must submit a notification to the Ministry of Health, Labour and Welfare (MHLW) after committee approval
If Class I (e.g., allogeneic NK cells), MHLW must grant formal approval before the therapy can begin
4
Secure or Register a Cell Processing Facility
Secure or Register a Cell Processing Facility
The clinic must either process the NK cells in an in-house facility registered with MHLW or contract a licensed Specified Cell Processing Facility
All facilities must comply with GCTP (Good Cell and Tissue Practice) standards
5
Obtain Informed Consent from Patients
Obtain Informed Consent from Patients
Patients must receive a standardized explanation of the risks and unapproved nature of the therapy
They must sign informed consent documents before treatment
6
Begin Treatment According to Approved Plan
Begin Treatment According to Approved Plan
Clinics may only administer the therapy strictly according to the authorized plan (e.g., dose, frequency, monitoring)
Any deviation requires new review and re-submission
7
Report Adverse Events
Report Adverse Events
Serious side effects (e.g., infections) must be immediately reported to MHLW and the certified committee
The Ministry has authority to suspend or terminate the therapy if risks are identified
8
Submit Periodic Reports to MHLW
Submit Periodic Reports to MHLW
Clinics must submit regular updates on patient numbers, outcomes, adverse events, and operational compliance
MHLW conducts inspections and may issue improvement or emergency orders if necessary
Who governs regulations around NK Killer cells in Japan
- The MHLW is the primary regulator setting policy and enforcing the ASRM. Within MHLW, the Research and Development Division handles regenerative medicine oversight.
- The PMDA (an independent agency under MHLW) evaluates product applications and oversees drug trials.
- Certified Committees for Regenerative Medicine are semi-independent bodies (often based at universities or medical societies) that play a crucial gatekeeping role in reviewing NK therapy proposals
Can I get NK Killer Cells for Cancer legally in Japan?
Yes, you can legally get NK Killer Cells for Cancer in Japan through private clinics. But remember, it’s still classed as an experimental treatment.
Most clinics that offer NK cell therapy in Japan use it to try to:
- Boost immunity against tumors
- Prevent recurrence after chemotherapy or surgery
- Support patients with advanced or refractory cancer
But you must make sure you’re treated at a clinic or hospital that has an approved NK cell treatment plan on file with the MHLW.
Risks in of getting NK KIller Cells in Japan
Serious infections are one of the major side effects you can get with NK Killer cells in Japan if you’re not visiting the right clinic & not all plans that get passed are high quality
In October 2024, the MLHW stepped in & suspended the K Clinic in Tokyo performing Autologous NK cell therapy for the prevention of malignant tumors due to “ Two patients were diagnosed with serious infections suspected to be caused by the provision of regenerative medicine, etc., and required hospitalization at a medical institution for treatment.”
According to a research paper published by Japan’s national cancer centre many therapeutic plans reviewed and approved under Japan’s ASRM system lack scientific rigor, transparency, and independence. For example:
25.1% of Class II therapy plans (including NK cell therapy) relied on poor or questionable scientific evidence. Suggesting that many therapies may not be based on credible proof of safety.
30% In 30% of plans, doctors were administering cell therapies for diseases outside their specialty (e.g., cosmetic surgeons treating cancer).
65% With 65% of therapy plans, informed consent forms were written by the same individuals across multiple clinics
52% 52% of clinics’ websites used language implying government approval or endorsement, mislead patients into thinking therapies are officially endorsed or proven
Can I get NK Killer Cell Therapy In Japan?
Yes, you can get NK Killer Cell Therapy in Japan. BUT
- Whilst there are some legitimate providers in Japan, even ones that are approved may not be above board.
- Be extremely careful when selecting which clinic you’re visiting for NK Killer Cells in Japan!
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No, as of December 2025, Nk Cell Therapy is NOT approved by the FDA.
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