INSTITUTION PROFILE / CELL CULTURE TECHNOLOGY
AMED
The agency that hands out Japan's research money for regenerative and cell medicine
AMED, the Japan Agency for Medical Research and Development, is a national research and development agency that distributes Japan's medical research funding. It does not do research or develop products itself. It was set up to run medical R&D in one place, work that had previously been handled separately by three ministries: education and science (MEXT), health (MHLW), and economy and industry (METI). Its job, for everything from university-led clinical trials to companies' manufacturing technology, is to run calls for proposals, select projects, manage their progress and evaluate the results. This profile looks at one question only: how much influence AMED actually has over cell culture technology (regenerative medicine and cell therapy).
- AMED in 30 seconds
- What kind of body it is: the four types of influence
- What it does for cell culture technology
- How far its influence reaches (powers and geography)
- Where the money goes and who receives it
- Outlook
- Glossary, references and claim-to-source audit
1. AMED in 30 seconds
AMED hands out research money; it has no power to approve or regulate. AMED's basic information says it carries out its work "based on the Plan for Promotion of Medical Research and Development drawn up by the Headquarters for Healthcare Policy" Sourced. The government's plan sets the broad priorities, and AMED follows it by running calls for proposals, selection, progress management and evaluation. Its influence on cell culture technology is still large, because some cell products developed with AMED support have gone on to be approved after PMDA review (section 5).
2. What kind of body it is: the four types of influence
Unlike the companies in this series, none of the institutions that appear in cell culture coverage makes cells or products. What separates them is the route by which they influence the industry, and that gives four types.
3. What it does for cell culture technology
Of AMED's eight integrated projects, the one that bears directly on cell culture technology is the Regenerative/Cell Medicine and Gene Therapy Project (¥19.6 billion in FY2026). It is divided into the following programmes Sourced.
| Programme (our translation of the name) | What it covers | Stage |
|---|---|---|
| Programme to accelerate the realisation of regenerative/cell medicine and gene therapy | Creating breakthrough research seeds, licensing them to companies, research combining regenerative/cell medicine with gene therapy, disease modelling and drug discovery using disease-specific iPS cells, and training young researchers | Basic to preclinical |
| Research programme for the practical application of regenerative medicine | Seamless support, from non-clinical work through to the clinic, for investigator-initiated clinical trials of regenerative medicine products developed in academia and for clinical research under the Act on the Safety of Regenerative Medicine (the law governing regenerative medicine offered by hospitals and clinics) | Applied research to clinical trials |
| Programme to promote infrastructure for the practical application of regenerative medicine | Building support structures for translational research, such as consortia of specialist staff and links between research institutions, hospitals and manufacturing organisations | Not applicable |
| Programme for foundational technologies for the industrialisation of regenerative medicine and gene therapy | Support for companies' non-clinical studies and for establishing quality standards and manufacturing methods; drug discovery tools using iPS cells and other cells; automating the manufacturing processes for cell products; establishing Japanese-made cell lines for producing viral vectors; and more | Varies by programme (mainly non-clinical) |
"Next-generation manufacturing technology development for regenerative medicine and cell therapy" is a programme led by companies that develop and sell manufacturing and analytical equipment. It aims at automating manufacturing processes on QbD principles (building quality in at the design stage), connecting instruments to one another, and developing equipment that can export data in general-purpose, internationally usable formats. In FY2025 it selected projects from Yokogawa Electric (an automated culture platform using fully closed bags) and Terumo (an automated culture system that runs the iPS cell expansion step) Sourced. Research money for cell therapy tends to be thought of as money for universities, but in this programme the culture equipment itself is what gets funded.
4. How far its influence reaches (powers and geography)
| Aspect | What AMED has | What it does not have |
|---|---|---|
| Powers | The power to run calls for research funding, select projects, manage progress and evaluate results. It sets the eligibility rules for applications (such as the stage covered and the requirements for principal investigators) | Any power to set approvals, licences, prices or standards. The power to set the broad priorities, which follow the government's Plan for Promotion of Medical Research and Development |
| Geography | Japan's budget. The principal investigator must belong to a research institution in Japan, and partner institutions are in principle also Japanese (FY2026 call guidelines for the research programme for the practical application of regenerative medicine) | Any power to directly influence foreign companies or other countries' policies |
| International ties | Offices in Washington D.C. and London (the Singapore office closed in March 2020) | Any mechanism that makes overseas research institutions its main recipients |
| Scale | 791 staff. FY2026 subsidies of ¥116.9 billion, operating grants of ¥6.7 billion and adjustment funds of ¥17.5 billion (expected) | The amount spent on cell culture technology alone is not broken down below the level of the Regenerative/Cell Medicine and Gene Therapy Project, which includes gene therapy |
Different documents draw the boundary of AMED's budget in different places. AMED's basic information gives "subsidies for AMED" of ¥116.9 billion and "operating grants" of ¥6.7 billion, while the Cabinet Secretariat gives "AMED-funded expenses" of ¥123.8 billion as a total across ministries (MEXT ¥58.3 billion, MHLW ¥48.1 billion, METI ¥16.6 billion and others) Sourced. The first two add up to ¥123.6 billion, and the published documents do not explain the difference from ¥123.8 billion Not yet confirmed. The ¥19.6 billion project also includes gene therapy, so the amount for research that uses cell culture alone is smaller than that.
5. Where the money goes and who receives it
Cell products that went from AMED support to approval
AMED publishes a list of products that were developed with its support and received SAKIGAKE designation from the Minister of Health, Labour and Welfare. SAKIGAKE is a Japanese fast-track scheme that gives priority consultation and review to breakthrough products. The cell-based items on that list, and what later happened to them in PMDA's lists of approved products, are as follows.
| Item as named in AMED's list (applicant) | Date of designation | What happened next (PMDA's lists of approved products) | Link to this series |
|---|---|---|---|
| Allogeneic iPS cell-derived dopaminergic neural progenitor cells (Dainippon Sumitomo Pharma) | 28 February 2017 | Received conditional and time-limited approval on 6 March 2026 as Sumitomo Pharma's Amchepry (listed as a SAKIGAKE-designated product) | See our Sumitomo Pharma profile. The company changed its name from Dainippon Sumitomo Pharma in April 2022 |
| STR01, autologous bone marrow mesenchymal stem cells (Nipro) | 10 February 2016 | Received conditional and time-limited approval on 28 December 2018 as Nipro's Stemirac Inj. (autologous bone marrow-derived mesenchymal stem cells), listed as a SAKIGAKE-designated product | See our Nipro profile |
| CliniMACS CD34 System (Miltenyi Biotec and Teijin) | 27 March 2018 | Designated as a medical device. We have not confirmed any subsequent approval | See our Miltenyi Biotec profile |
The item names in AMED's list are not the same as the brand names in PMDA's lists. We matched them because the company, the cell type and the SAKIGAKE designation all agree Our calculation.
6. Outlook
| What the evidence suggests | Primary information it rests on | Category |
|---|---|---|
| AMED's support will extend beyond university clinical research to manufacturing technology (automation and data), and equipment and materials makers will more often receive its money directly | The project overview includes "strengthening the manufacturing base for cells and vectors" and "building up know-how at CDMOs", and the next-generation manufacturing technology programme is led by equipment makers | Inference |
| AMED's overall budget will not grow much, so the split between projects will determine its influence | AMED-funded expenses went from ¥123.2 billion in FY2025 to ¥123.8 billion in FY2026, an increase of 0.5% | Inference |
7. Glossary
- National R&D agency
- A public body that carries out national research and development under the supervision of a minister. It is not itself a ministry.
- Integrated project
- One of the eight groupings into which AMED organises its programmes by purpose. The Regenerative/Cell Medicine and Gene Therapy Project is one of them.
- Investigator-initiated clinical trial
- A clinical trial planned and run by physicians rather than by a company. Often used to develop cell products that originate in universities.
- SAKIGAKE designation
- A scheme that designates breakthrough medicines or regenerative medicine products at an early stage of development and gives them priority consultation and review. A 2019 amendment to the PMD Act, Japan's main pharmaceutical law, turned it into the designation system for pioneering pharmaceuticals and similar products.
- QbD
- Quality by Design: the idea of building a product's quality in scientifically from the stage at which the manufacturing process is designed (see our explainer on QbD and CMC).
8. References
- AMED Basic information (in Japanese): name, purpose, date of establishment, supervising ministers, governing laws, staff numbers and FY2026 budget. Updated 13 April 2026. https://www.amed.go.jp/aboutus/kihon.html
- AMED AMED's role and functions (in Japanese): running in one place the medical R&D that three ministries had carried out separately, managing research projects through a plan-do-check-act cycle, and the eight integrated projects. https://www.amed.go.jp/aboutus/yakuwari.html
- AMED Activity reports of the overseas offices (in Japanese): the Washington D.C. and London offices, and the closure of the Singapore office. https://www.amed.go.jp/aboutus/katsudou.html
- Cabinet Secretariat, Office of Healthcare Policy Key points of the FY2026 budget for medical R&D (in Japanese): ¥19.6 billion for the Regenerative/Cell Medicine and Gene Therapy Project, ¥123.8 billion in AMED-funded expenses with a breakdown by ministry, and ¥123.2 billion the previous year. https://www.cas.go.jp/jp/seisakukaigi/kenkouiryou/iyakuhin/iyakuhinkyougikai_dai2/sanko3.pdf
- AMED Regenerative/Cell Medicine and Gene Therapy Project (in Japanese): overview and list of programmes. Updated 24 July 2026. https://www.amed.go.jp/program/list/index03.html
- AMED Programme for foundational technologies for the industrialisation of regenerative medicine and gene therapy: next-generation manufacturing technology development for regenerative medicine and cell therapy (in Japanese). Programme overview and projects selected in FY2025. https://www.amed.go.jp/program/list/13/01/014.html
- AMED Call guidelines for the research programme for the practical application of regenerative medicine, FY2026 call (in Japanese): eligible applicants and requirements for partner institutions. https://www.amed.go.jp/content/000152310.pdf
- AMED AMED-supported research results that received designation as pioneering pharmaceuticals and similar products (in Japanese): designated regenerative medicine products and medical devices, and their applicants. https://www.amed.go.jp/seika/senkuteki_index.html
- PMDA List of regenerative medicine products approved in FY2025 (in Japanese): conditional and time-limited approval of Amchepry. https://www.pmda.go.jp/files/000280052.pdf
- PMDA List of regenerative medicine products approved in FY2018 (in Japanese): conditional and time-limited approval of Stemirac Inj. https://www.pmda.go.jp/files/000231456.pdf
- Sumitomo Pharma Annual securities report filed 23 June 2026 (in Japanese), company history: change of name from Dainippon Sumitomo Pharma in April 2022. https://www.sumitomo-pharma.co.jp/ir/library/securities_report/assets/pdf/securities_report_20260623.pdf
9. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| Full name, English name, establishment on 1 April 2015, supervising ministers, governing laws, 791 staff, FY2026 subsidies of ¥116.9 billion, operating grants of ¥6.7 billion and adjustment funds of ¥17.5 billion, work based on the Plan for Promotion of Medical Research and Development, and headquarters location | Sourced | Reference 1 https://www.amed.go.jp/aboutus/kihon.html |
| Running the three ministries' R&D in one place, management through a plan-do-check-act cycle, and the eight integrated projects | Sourced | Reference 2 https://www.amed.go.jp/aboutus/yakuwari.html |
| The Washington D.C. and London offices, and the closure of the Singapore office (March 2020) | Sourced | Reference 3 https://www.amed.go.jp/aboutus/katsudou.html |
| ¥19.6 billion for the Regenerative/Cell Medicine and Gene Therapy Project; ¥123.8 billion in AMED-funded expenses (MEXT ¥58.3 billion, MHLW ¥48.1 billion, METI ¥16.6 billion, Children and Families Agency ¥0.7 billion, Ministry of Internal Affairs and Communications ¥0.3 billion); ¥123.2 billion the previous year and growth of 0.5% | Sourced | Reference 4 https://www.cas.go.jp/jp/seisakukaigi/kenkouiryou/iyakuhin/iyakuhinkyougikai_dai2/sanko3.pdf |
| The project overview (strengthening the manufacturing base, building up know-how at CDMOs) and the content and stage of the four programmes | Sourced | Reference 5 https://www.amed.go.jp/program/list/index03.html |
| The next-generation manufacturing technology programme is led by equipment makers; QbD and general-purpose data formats; selection of Yokogawa Electric and Terumo projects in FY2025 | Sourced | Reference 6 https://www.amed.go.jp/program/list/13/01/014.html |
| The principal investigator must belong to a research institution in Japan, and partner institutions are in principle also Japanese | Sourced | Reference 7 https://www.amed.go.jp/content/000152310.pdf |
| AMED-supported SAKIGAKE-designated items (iPS cell-derived dopaminergic neural progenitor cells, STR01, CliniMACS CD34 System), their dates of designation and applicants | Sourced | Reference 8 https://www.amed.go.jp/seika/senkuteki_index.html |
| Conditional and time-limited approval of Amchepry (6 March 2026, SAKIGAKE-designated product) | Sourced | Reference 9 https://www.pmda.go.jp/files/000280052.pdf |
| Conditional and time-limited approval of Stemirac Inj. (28 December 2018, SAKIGAKE-designated product) | Sourced | Reference 10 https://www.pmda.go.jp/files/000231456.pdf |
| Change of name from Dainippon Sumitomo Pharma to Sumitomo Pharma (April 2022) | Sourced | Reference 11 https://www.sumitomo-pharma.co.jp/ir/library/securities_report/assets/pdf/securities_report_20260623.pdf |
| The four types of institution, and the selection of recipients in Fig. 2 | Our calculation | Our own classification |
| Matching items in AMED's list to PMDA brand names | Our calculation | Our own matching by company, cell type and designation, from references 8 to 11 |
| What accounts for the difference between subsidies plus operating grants (¥123.6 billion) and AMED-funded expenses (¥123.8 billion), and the amount spent on cell culture technology alone | Not yet confirmed | Not stated in references 1 and 4; this article does not estimate them |
| The two points in the outlook (section 6) | Inference | This article's reading of references 4, 5 and 6 |
Last updated 24 September 2026 / Troy Technical
All figures come from AMED's website and call guidelines, the Cabinet Secretariat's budget documents, PMDA's lists of approved products and Sumitomo Pharma's annual securities report. Items marked "Inference" are this article's reading of the primary information, not statements by AMED.