INSTITUTION PROFILE / iPS CELLS & REGENERATIVE MEDICINE
AMED (Japan Agency for Medical Research and Development)
The agency that hands out Japan's iPS cell and regenerative medicine research money
AMED is a national research and development agency overseen jointly by four competent ministers: the Prime Minister and the ministers for education and science (MEXT), health (MHLW) and the economy (METI). It makes neither iPS cells nor regenerative medicine products. Its job is to distribute the government's medical research budget to universities, hospitals and companies, then keep track of how the work is going. This profile asks one question: how much influence AMED really has over iPS cells and regenerative medicine. It also sets out how AMED's role differs from that of the Minister of Health, Labour and Welfare, who decides approvals, and from PMDA, which carries out the reviews.
- AMED in 30 seconds
- What kind of body it is: the four types of influence
- What it does for iPS cells and regenerative medicine
- How far its influence reaches (powers and geography)
- Who else is involved: the flow of money and the flow of approval
- Outlook
- Glossary, references and claim-to-source audit
1. AMED in 30 seconds
Getting a regenerative medicine product onto the Japanese market involves three organisations with three different jobs. AMED pays for research, PMDA reviews applications, and the Minister of Health, Labour and Welfare grants approval. PMDA describes itself as the body that carries out approval reviews for regenerative medicine products and similar products Sourced, and under Japan's Pharmaceuticals and Medical Devices Act (PMD Act) the approval itself is a power of the Minister Sourced. AMED is neither of these. It is the party that funds the research and development stage that comes before approval. It still matters, because AMED runs the open-call programmes that support work on iPS cells continuously, from the laboratory through to the period before and after clinical trials.
2. What kind of body it is: the four types of influence
Unlike the companies in this series, the institutions that appear in iPS cell and regenerative medicine coverage do not sell products. What separates them is the route by which they influence the industry, and that gives four types.
3. What it does for iPS cells and regenerative medicine
AMED organises medical research into eight integrated projects Sourced. iPS cells and regenerative medicine fall under its project on regenerative medicine, cell therapy and gene therapy. The main programmes are these.
| Programme | What it covers | Stage targeted |
|---|---|---|
| Acceleration Program for Regenerative Medicine, Cell Therapy and Gene Therapy (from FY2023) | Successor to the Network Program for Realization of Regenerative Medicine. It has five sub-programmes: core research hubs; research and development projects (preclinical proof of concept, and basic-to-applied work); research on disease mechanisms and drug discovery using disease-specific iPS cells; and support for practical application. It is also building a bank of disease-specific iPS cells, deposited with the RIKEN BioResource Research Center | Basic to preclinical |
| Practical Application Research Program for Regenerative Medicine | Provides continuous support from preclinical to clinical work for investigator-initiated clinical trials of regenerative medicine products (under the PMD Act) and for clinical studies of regenerative medicine technologies (under the Act on the Safety of Regenerative Medicine). It also covers research that applies iPS and ES cell differentiation systems and organoids to new drug development | Applied to clinical trials |
| Program to Promote Infrastructure for the Practical Application of Regenerative Medicine | Builds the supporting infrastructure for practical application: a consortium of specialists, and links among research institutions, hospitals and manufacturers. The aim is to make research more efficient, more standardised and cheaper | Infrastructure |
| Basic Technology Development for Industrialising Regenerative Medicine and Gene Therapy (four programmes) | (1) Establishing preclinical studies, quality and manufacturing methods at companies, start-ups included; (2) drug-discovery support tools that use iPS cells and similar cells (biomimetic systems); (3) next-generation manufacturing technology such as automated cell production; (4) a manufacturing base for gene therapy, including domestically developed viral vector producer cell lines | Preclinical and manufacturing |
The acceleration programme and the practical application programme move academic research at universities and hospitals closer to clinical trials and clinical studies. One of the industrialisation programmes, by contrast, explicitly names "the company leading the development, including start-ups" as its target, and supports the preclinical studies, quality and manufacturing methods a company needs before it can move on to a company-sponsored trial. Even within AMED's own funding, the design is that the recipient shifts from universities to companies as the stage advances.
4. How far its influence reaches (powers and geography)
| Aspect | What AMED has | What it does not have |
|---|---|---|
| Powers | The power to run open calls, select projects, monitor progress and evaluate results, operating on a plan-do-check-act cycle | The power to approve regenerative medicine products (held by the Minister of Health, Labour and Welfare), review (PMDA), and responsibility for the procedures under the Act on the Safety of Regenerative Medicine for treatment plans and manufacturing facilities (MHLW) |
| Geography | Programmes funded from Japan's medical research budget. Recipients are mainly Japanese research institutions and companies | Any direct authority over other countries' approval systems or research funding |
| Scale | 791 staff. FY2026 subsidies for AMED of ¥116.9 billion (all fields combined) | The total spent on iPS cells and regenerative medicine alone (not found in the sources used for this article) |
The 791 staff and ¥116.9 billion cover every field AMED handles, including cancer, infectious disease, drugs and medical devices Sourced. The official pages we checked do not give the headcount of the regenerative medicine department, or an annual budget for this field alone. We therefore do not derive figures for this field from the overall numbers Not yet confirmed.
5. Who else is involved: the flow of money and the flow of approval
The core research hub (NCGT) is one of the sub-programmes of the acceleration programme. It works on developing next-generation iPS cells, clarifying the mechanisms of reprogramming and developing innovative genome-editing technology, among other things Sourced. Its lead investigator is a professor at the Center for iPS Cell Research and Application (CiRA) at Kyoto University, and four institutions act as hubs: CiRA, Jichi Medical University, the National Center for Child Health and Development, and the Kyoto University iPS Cell Research Foundation Sourced. The hub's own website states that clinical studies or clinical trials have already begun in Japan for more than ten research projects that use iPS cells Sourced. That is the hub's own statement, not a figure compiled by AMED.
The official MHLW page says the ministry works with other ministries to support research and development consistently from basic research to the clinical stage, and promotes the practical application of regenerative medicine through grants for clinical research and for drug-discovery research that uses iPS cells Sourced. The page does not make clear whether that grant money passes through AMED or is paid directly by the ministry Not yet confirmed.
6. Outlook
| What the evidence suggests | Primary information it rests on | Category |
|---|---|---|
| AMED's support will keep its emphasis on integrated research that treats regenerative medicine, cell therapy and gene therapy together | The outline of the acceleration programme calls for "further integration" of the two fields, and the MHLW page says that an amendment on 31 May 2025 brought gene therapy that does not use processed cells within the scope of the Act on the Safety of Regenerative Medicine | Inference |
| The recipients of funding will widen to the industrialisation stage: manufacturing, quality and automation | Four industrialisation programmes support companies' preclinical work and quality assurance, and the development of next-generation manufacturing technology | Inference |
| The amount of each programme depends on each year's budget, so this article cannot give future figures for iPS cells and regenerative medicine | The overview page publishes budgets year by year and notes that fund-based programmes and government-investment programmes are counted separately | Not yet confirmed |
7. Glossary
- National R&D agency
- A public body that carries out national research and development under the supervision of competent ministers. It is not itself a ministry.
- Integrated project
- One of eight groupings into which AMED organises medical research by field. iPS cells and regenerative medicine fall under "regenerative medicine, cell therapy and gene therapy".
- Investigator-initiated clinical trial
- A clinical trial run by doctors or medical institutions rather than by a company, with the aim of applying for approval.
- Act on the Safety of Regenerative Medicine
- The law that sets the procedures for medical institutions providing regenerative medicine and for facilities that process cells. It is administered by MHLW.
- Disease-specific iPS cells
- iPS cells made from a patient's own cells. They are used to study how a disease works and in drug discovery research.
- Preclinical proof of concept
- The stage before human studies at which animal or cell experiments show that an effect is likely.
8. References
- AMED Basic information (in Japanese): name, date of establishment, competent ministers, governing laws, staff numbers, FY2026 budget and history. Updated 13 April 2026. https://www.amed.go.jp/aboutus/kihon.html
- AMED AMED's role and functions (in Japanese): its command-centre function for medical R&D, the consolidation of three ministries' R&D, and the eight integrated projects. https://www.amed.go.jp/aboutus/yakuwari.html
- AMED Regenerative medicine, cell therapy and gene therapy project (in Japanese): the department, the list of programmes and an outline of each. https://www.amed.go.jp/program/list/index03.html
- AMED Acceleration Program for Regenerative Medicine, Cell Therapy and Gene Therapy (in Japanese): successor to the Network Program for Realization of Regenerative Medicine, start in FY2023, sub-programmes and the bank of disease-specific iPS cells. https://www.amed.go.jp/program/list/13/01/013.html
- AMED Practical Application Research Program for Regenerative Medicine (in Japanese): the support categories for investigator-initiated trials and clinical studies, and the application of iPS cells and similar cells to drug discovery. https://www.amed.go.jp/program/list/13/01/002.html
- NCGT Message from the lead investigator, core research hub for regenerative medicine, cell therapy and gene therapy (in Japanese): the four hub institutions, and the statement that clinical studies or trials have begun in Japan for more than ten iPS cell research projects. https://ncgt.cira.kyoto-u.ac.jp/j/about/
- NCGT Organisation and research co-investigators, core research hub for regenerative medicine, cell therapy and gene therapy (in Japanese): the role of each institution. Updated 7 July 2025. https://ncgt.cira.kyoto-u.ac.jp/j/structure/
- Ministry of Health, Labour and Welfare (MHLW) On regenerative medicine, cell therapy and gene therapy (in Japanese): the Act on the Safety of Regenerative Medicine, the amendment in force from 31 May 2025, procedures for providing treatment, and MHLW's own research grants. https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iryou/saisei_iryou/index.html
- PMDA About PMDA (in Japanese): its three roles, including approval review for regenerative medicine products and similar products. https://www.pmda.go.jp/about-pmda/outline/0001.html
- e-Gov Law Search Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the PMD Act) (in Japanese), Articles 23-20 to 23-27: approval of regenerative medicine products. https://laws.e-gov.go.jp/law/335AC0000000145
9. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| Name, establishment on 1 April 2015, the four competent ministers, governing laws, 791 staff (1 April 2026), and FY2026 subsidies of ¥116.9 billion, operating grants of ¥6.7 billion and a coordination budget of ¥17.5 billion | Sourced | Reference 1 https://www.amed.go.jp/aboutus/kihon.html |
| Its command-centre function for medical R&D, the consolidation of three ministries' R&D, and the eight integrated projects | Sourced | Reference 2 https://www.amed.go.jp/aboutus/yakuwari.html |
| The make-up of the regenerative medicine, cell therapy and gene therapy department, and the outline of each programme (practical application infrastructure, the four industrialisation programmes) | Sourced | Reference 3 https://www.amed.go.jp/program/list/index03.html |
| The acceleration programme: successor to the network program, start in FY2023, sub-programmes, the bank of disease-specific iPS cells and deposit with RIKEN BRC | Sourced | Reference 4 https://www.amed.go.jp/program/list/13/01/013.html |
| The support categories of the practical application research programme, investigator-initiated trials and clinical studies, and the use of iPS cells and similar cells in drug discovery | Sourced | Reference 5 https://www.amed.go.jp/program/list/13/01/002.html |
| The statement that clinical studies or trials have begun for more than ten iPS cell research projects in Japan, and the four hub institutions | Sourced | The hub's own statement / Reference 6 https://ncgt.cira.kyoto-u.ac.jp/j/about/ |
| The role of each institution, and that the lead investigator is a CiRA professor | Sourced | Reference 7 https://ncgt.cira.kyoto-u.ac.jp/j/structure/ |
| The Act on the Safety of Regenerative Medicine, the amendment of 31 May 2025, and MHLW's research grants (the route of the money is unclear) | Sourced | Reference 8 https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iryou/saisei_iryou/index.html |
| PMDA carries out approval review for regenerative medicine products and similar products | Sourced | Reference 9 https://www.pmda.go.jp/about-pmda/outline/0001.html |
| Approval of regenerative medicine products is a power of the Minister of Health, Labour and Welfare | Sourced | Reference 10 https://laws.e-gov.go.jp/law/335AC0000000145 |
| The four types of institution, and the groupings in Fig. 2 | Our calculation | Our own classification in this article |
| Budget or headcount for iPS cells and regenerative medicine alone | Not yet confirmed | Not stated in references 1 to 5; this article does not estimate them |
| The two inferences in the outlook (section 6) | Inference | This article's reading of the programme contents in references 3, 4 and 8 and of the legal amendment |
Last updated 1 October 2026 / Troy Technical
All figures come from the official websites of AMED, MHLW and PMDA and from legislation. Items marked "Inference" are this article's reading of the primary information, not statements by those bodies.