INSTITUTION PROFILE / iPS CELLS & REGENERATIVE MEDICINE
Ministry of Health, Labour and Welfare (MHLW)
The ministry that controls both legal routes into Japan's regenerative medicine: approval and notification
The MHLW is a national government ministry of Japan. For regenerative medicine, including iPS cell-based therapy, it handles approvals, designations, receipt of notifications and proposals for insurance coverage. The practical review work is done by the PMDA and research grant programmes are run by AMED, so the roles are divided. What sets the MHLW apart is that it oversees two separate legal routes: one for companies that sell a product, and one for medical institutions that provide treatment through clinical research or privately paid care. This profile looks at one question only: how much influence the MHLW actually has over iPS cells and regenerative medicine.
What this article covers
- The MHLW 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)
- Companies and organisations it works with
- Outlook
- Glossary, references and claim-to-source audit
1. The MHLW in 30 seconds
FULL NAMEMinistry of Health, Labour and WelfareUsually abbreviated MHLW
COUNTRYJapanMain office at 1-2-2 Kasumigaseki, Chiyoda-ku, Tokyo
TYPE OF BODYNational government ministryHas bureaus including the Health Policy Bureau and the Pharmaceutical Bureau. The Minister decides approvals and designations
ESTABLISHEDLaunched January 2001The Act for Establishment of the MHLW took effect with the reform of central government ministries and agencies
STAFF32,939Authorised headcount at the end of FY2026. A figure for the whole ministry, including labour bureaus nationwide
BUDGET¥35.0433 trillion (general account)FY2026 budget proposal. The published documents give no separate figure for regenerative medicine
ROLE IN iPS CELLS AND REGENERATIVE MEDICINEApproval decisions and system designApproves regenerative medicine products, receives notifications for clinical research and privately paid care, and puts coverage to the Council
REACHWithin JapanIt extends to facilities abroad through its accreditation of foreign manufacturers that supply Japan
The one thing to grasp first
Japan has two legal doors into regenerative medicine. The route for companies that sell a product runs through the Pharmaceuticals and Medical Devices Act (the "regenerative medicine product" category), and the route for medical institutions that provide treatment through clinical research or privately paid care runs through the Act on the Safety of Regenerative Medicine Sourced. On both, the final decisions rest with the MHLW (the Minister). The PMDA does the practical review and AMED runs the research grant programmes, and the MHLW is the party that approves, designates, receives notifications and puts insurance prices to the Council Sourced.
2. What kind of body it is: the four types of influence
Unlike the companies in this series, the institutions that appear in coverage of iPS cells and regenerative medicine do not make cells themselves. 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
The MHLW's roles in regenerative medicine can be divided as follows Sourced.
| Role | What it involves | Document behind it |
|---|---|---|
| Product approval and designation | The Minister of Health, Labour and Welfare approves the marketing of regenerative medicine products. The Medical Device Evaluation Division of the Pharmaceutical Bureau handles manufacturing licences for regenerative medicine products, re-examination, and designations such as SAKIGAKE and orphan designation | The Pharmaceutical Bureau's statement of duties, and the PMDA's guide to the marketing procedure |
| Conditional and time-limited approval | For a regenerative medicine product that is not homogeneous, the Minister can grant approval with conditions and a time limit of no more than seven years, after seeking the opinion of the Pharmaceutical Affairs and Food Sanitation Council. The MHLW also issues the notifications on how this works in practice | Article 23-26 of the Pharmaceuticals and Medical Devices Act (quoted in the guidance) |
| Notifications for clinical research and privately paid care | A medical institution that wants to provide regenerative medicine must first submit a provision plan. Treatments are sorted into Class I to Class III by the size of their potential effect on people, and iPS cells are given as an example of Class I. The amendment of 31 May 2025 also brought gene therapies that do not use processed cells into scope | The page on regenerative medicine, cell medicine and gene therapy, and the outline of the Act on the Safety of Regenerative Medicine |
| Enforcement status | As of 30 June 2026 there were 167 certified regenerative medicine committees and 3,671 facilities manufacturing specified processed cells (85 licensed, 3,586 notified). Provision plans numbered 6,743 for treatment and 85 for research | The published enforcement statistics |
| Research ethics guidelines | When human ES cells are derived for use in medicine, the Minister must confirm that the derivation meets the guidelines, and seeks the opinion of the Regenerative Medicine Evaluation Subcommittee of the Health Sciences Council | The page on regenerative medicine, cell medicine and gene therapy |
| Insurance coverage review | For an approved regenerative medicine product, the Central Social Insurance Medical Council (Chuikyo) is shown whether it should be treated as a drug or a medical device, together with a proposed price | Chuikyo documents (April to July 2026) |
| Support for research and development | The Research and Development Policy Division of the Health Policy Bureau handles research and development in regenerative medicine and the Act on the Safety of Regenerative Medicine. The FY2026 budget proposal includes promoting the practical use of regenerative medicine, cell medicine and gene therapy | The Health Policy Bureau's statement of duties, and the budget proposal summary |
| Reporting desk | On 2 September 2026 it opened an information and reporting desk for regenerative medicine | The page on regenerative medicine, cell medicine and gene therapy |
A materials engineer's view: the same cells face different demands depending on the route
On the route where a company sells a product, the company must pass a GCTP inspection of its manufacturing site and a marketing approval review. On the route where a medical institution provides treatment, it needs a provision plan and a licence or notification for the facility that processes the cells Sourced. For a supplier of materials or culture media, the quality documentation and audits a customer asks for are likely to differ depending on whether the customer is a company seeking approval or a cell processing facility run by a medical institution that provides treatment by notification (our interpretation).
The proposed prices for the two iPS cell-derived products put to Chuikyo in 2026 are shown below Sourced. This article has not verified whether the listings actually took place.
| Brand name (company) | Treatment put to Chuikyo | Proposed price and timing |
|---|---|---|
| ReHeart (Cuorips) | Treated as a medical device (category C2). Cost-accounting method, with a 10% marketability premium | ¥53,200,000. In the Council's general meeting papers of 22 July 2026, with listing planned for 1 September |
| AMCHEPRY (Sumitomo Pharma) | Treated as a drug. Cost-accounting method, with a 10% marketability premium and a 10% SAKIGAKE premium | ¥55,306,737. In the general meeting papers of 13 May 2026, with listing planned for 20 May |
4. How far its influence reaches (powers and geography)
| Aspect | What the MHLW has | What it does not have |
|---|---|---|
| Powers | Approval, conditional and time-limited approval, SAKIGAKE designation and accreditation of foreign manufacturers for regenerative medicine products. Receiving provision plans and applying emergency and improvement orders. Putting proposals on insurance coverage and price | The practical review (the PMDA). Running the research grant programmes (AMED). The final deliberation on insurance coverage (Chuikyo) |
| Geography | The Japanese market and regenerative medicine provided to patients in Japan. Facilities abroad that manufacture for Japan also fall within its scope through accreditation (19 overseas facilities manufacturing specified processed cells are accredited: 13 in South Korea, 3 in Taiwan, 1 in China, 1 in Austria and 1 in Greece) | Decisions on approvals or research ethics in other countries. Provision to patients outside Japan |
| Scale | Authorised headcount of 32,939 (end of FY2026, whole ministry), of which 4,520 in internal bureaus. FY2026 general account budget proposal of ¥35.0433 trillion | Staff numbers or budget for regenerative medicine alone (no separate figure in the published documents) |
| International reference point | It publishes its laws, notifications and lists of approved products | Power to make other countries' regulators follow it |
A note on reading the numbers
The headcount and budget figures are for the whole ministry, which also covers pensions, labour, welfare and more Sourced. The enforcement figures are the numbers of notifications and licences under the Act on the Safety of Regenerative Medicine, not a count of iPS cell uses alone. The proposed prices put to Chuikyo are planned listings, and this article has not verified whether the listings actually took place Not yet confirmed.
5. Companies and organisations it works with
In Japan's regenerative medicine, deciding, reviewing, funding research and deliberating on price are done by different bodies. This section shows the division of work that can be confirmed from the MHLW's published documents.
Division of roles
| Organisation | Role in regenerative medicine | Source |
|---|---|---|
| MHLW | Approvals, designations, accreditation of foreign manufacturers, receipt of provision plans, issuing notifications and guidance, and proposing insurance coverage | References 2, 3, 12, 14 and 15 |
| PMDA | Consultation, approval review and inspection of manufacturing sites. It does not make the final approval decision | Reference 14 |
| AMED | Runs research grant programmes. The MHLW's page points to the programme page | Reference 1 |
| Pharmaceutical Affairs and Food Sanitation Council / Health Sciences Council | The former gives the Minister its opinion on conditional and time-limited approvals. The latter is asked for its opinion on matters such as confirming the human ES cell derivation guidelines | References 1 and 12 |
| Chuikyo | Deliberates on the insurance treatment and proposed price of regenerative medicine products | References 9, 10 and 11 |
| Cuorips, Sumitomo Pharma | Applicants for ReHeart and AMCHEPRY. Their names appear in the approval and pricing documents | References 9, 10, 11 and 13 |
6. Outlook
| What the evidence suggests | Primary information it rests on | Category |
|---|---|---|
| As iPS cell-derived products multiply, the judgement on moving from conditional and time-limited approval to full approval will become the focus of the system | Two products received conditional and time-limited approval in March 2026. The law sets a time limit of no more than seven years, and the October 2025 notification set out how it works in practice | Inference |
| Whether the two products approved in March 2026 win full approval within their time limits | This article has not verified each product's time limit or approval conditions | Not yet confirmed |
| Whether ReHeart was in fact listed (planned for 1 September 2026) | The Chuikyo document of 22 July 2026 says only that listing is planned | Not yet confirmed |
7. Glossary
- Pharmaceuticals and Medical Devices Act
- The law that secures the quality, efficacy and safety of drugs, medical devices and regenerative medicine products. It is the basis of the route for selling a product.
- Act on the Safety of Regenerative Medicine
- The law that sets the procedure by which medical institutions provide regenerative medicine, and the licences and notifications for facilities that process cells.
- Provision plan
- A plan that a medical institution submits to the Minister, after seeking the opinion of a certified committee, before it provides regenerative medicine.
- Specified processed cells
- Human or animal cells that have been processed, for example by culture, for use in regenerative medicine (excluding approved products).
- Chuikyo
- The Central Social Insurance Medical Council. It deliberates on matters such as the prices of care covered by insurance.
8. References
- MHLW Regenerative medicine, cell medicine and gene therapy (in Japanese): the amendment of 31 May 2025, procedures, advisory councils, the human ES cell derivation guidelines, the link to AMED's programme page and the reporting desk. Includes the update of 2 September 2026. https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iryou/saisei_iryou/index.html
- MHLW Statement of duties of the Pharmaceutical Bureau (in Japanese): the Medical Device Evaluation Division and its work on manufacturing licences, re-examination and designations for regenerative medicine products. https://www.mhlw.go.jp/content/001280485.pdf
- MHLW Statement of duties of the Health Policy Bureau (in Japanese): the Research and Development Policy Division, research and development in regenerative medicine and the Act on the Safety of Regenerative Medicine. https://www.mhlw.go.jp/content/000701455.pdf
- MHLW Outline of the MHLW's organisation and staffing for FY2026 (in Japanese): authorised headcount of 32,939 at the end of FY2026 and 4,520 in internal bureaus. https://www.mhlw.go.jp/content/10108000/001620628.pdf
- MHLW Outline of the FY2026 budget proposal (in Japanese): general account of ¥35.0433 trillion, ¥7.1 billion for improving the research and development environment and ¥55.7 billion for promoting innovation through research and development. https://www.mhlw.go.jp/wp/yosan/yosan/26syokanyosan/dl/01-01.pdf
- MHLW Location guide (in Japanese): 1-2-2 Kasumigaseki, Chiyoda-ku, Tokyo. https://www.mhlw.go.jp/kouseiroudoushou/shozaiannai/index.html
- MHLW The Act on the Safety of Regenerative Medicine (in Japanese): the three classes and the provision plan procedure, with iPS cells and similar given as an example of Class I. https://www.mhlw.go.jp/content/10808000/000565836.pdf
- MHLW Enforcement status of the Act on the Safety of Regenerative Medicine (in Japanese, as of 30 June 2026). https://www.mhlw.go.jp/content/001590173.pdf
- Central Social Insurance Medical Council General meeting document 11-1, "Treatment of regenerative medicine products under health insurance (list)" (in Japanese, 8 April 2026). https://www.mhlw.go.jp/content/10808000/001687603.pdf
- Central Social Insurance Medical Council General meeting document 5, "Insurance coverage of regenerative medicine products" (in Japanese, 13 May 2026): the proposed price for AMCHEPRY. https://www.mhlw.go.jp/content/10808000/001699508.pdf
- Central Social Insurance Medical Council General meeting document 2, "Insurance coverage of regenerative medicine products" (in Japanese, 22 July 2026): the proposed price for ReHeart. https://www.mhlw.go.jp/content/10808000/001726219.pdf
- MHLW (published on the PMDA site) Guidance on conditional and time-limited approval of regenerative medicine products and on drawing up a subsequent efficacy evaluation plan (in Japanese): the text of Article 23-26 of the Pharmaceuticals and Medical Devices Act. https://www.pmda.go.jp/files/000267914.pdf
- PMDA List of approved products for FY2025, regenerative medicine products (in Japanese): the approvals of ReHeart and AMCHEPRY. https://www.pmda.go.jp/files/000280052.pdf
- PMDA Procedure for marketing regenerative medicine products (in Japanese): approval by the Minister of Health, Labour and Welfare, with applications submitted at the PMDA's counter. https://www.pmda.go.jp/files/000216666.pdf
- MHLW Enforcement of the Act for Establishment of the MHLW and related acts following the reform of central government ministries and agencies (in Japanese, Iyakuhatsu No. 1318 of 27 December 2000). https://www.mhlw.go.jp/web/t_doc?dataId=00ta3826&dataType=1&pageNo=1
- PMDA Applying for accreditation as a foreign manufacturer of regenerative medicine products (in Japanese): accreditation by the Minister, with inspection of structure and equipment by the PMDA. https://www.pmda.go.jp/review-services/drug-reviews/foreign-mfr/0011.html
9. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| Full name and location (1-2-2 Kasumigaseki) | Sourced | Reference 6 https://www.mhlw.go.jp/kouseiroudoushou/shozaiannai/index.html |
| The entry into force of the Act for Establishment of the MHLW with the reform of central government ministries and agencies | Sourced | Reference 15 https://www.mhlw.go.jp/web/t_doc?dataId=00ta3826&dataType=1&pageNo=1 |
| Authorised headcount of 32,939 (end of FY2026) and 4,520 in internal bureaus | Sourced | Reference 4 https://www.mhlw.go.jp/content/10108000/001620628.pdf |
| General account of ¥35.0433 trillion (FY2026 budget proposal) and the research and development budget items | Sourced | Reference 5 https://www.mhlw.go.jp/wp/yosan/yosan/26syokanyosan/dl/01-01.pdf |
| Approval of regenerative medicine products by the Minister of Health, Labour and Welfare, with applications submitted at the PMDA's counter | Sourced | Reference 14 https://www.pmda.go.jp/files/000216666.pdf |
| The Pharmaceutical Bureau's statement of duties (manufacturing licences, re-examination, designations) | Sourced | Reference 2 https://www.mhlw.go.jp/content/001280485.pdf |
| The statement of duties of the Research and Development Policy Division of the Health Policy Bureau | Sourced | Reference 3 https://www.mhlw.go.jp/content/000701455.pdf |
| The amendment of 31 May 2025, the procedures, the advisory councils, confirmation of the human ES cell derivation guidelines, the pointer to AMED's programme page and the reporting desk | Sourced | Reference 1 https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iryou/saisei_iryou/index.html |
| The three classes of regenerative medicine and the provision plan procedure (iPS cells and similar as an example of Class I) | Sourced | Reference 7 https://www.mhlw.go.jp/content/10808000/000565836.pdf |
| 167 certified committees, 3,671 manufacturing facilities, the number of provision plans and 19 accredited overseas facilities (30 June 2026) | Sourced | Reference 8 https://www.mhlw.go.jp/content/001590173.pdf |
| The proposed insurance treatment of ReHeart and AMCHEPRY (medical device or drug) | Sourced | Reference 9 https://www.mhlw.go.jp/content/10808000/001687603.pdf |
| AMCHEPRY's proposed price of ¥55,306,737 (document of 13 May 2026) | Sourced | Reference 10 https://www.mhlw.go.jp/content/10808000/001699508.pdf |
| ReHeart's proposed price of ¥53,200,000 (document of 22 July 2026) | Sourced | Reference 11 https://www.mhlw.go.jp/content/10808000/001726219.pdf |
| The requirements for conditional and time-limited approval, the time limit of no more than seven years, and seeking the council's opinion | Sourced | Reference 12 https://www.pmda.go.jp/files/000267914.pdf |
| The approval date of ReHeart and AMCHEPRY (6 March 2026) and the form of approval | Sourced | Reference 13 https://www.pmda.go.jp/files/000280052.pdf |
| Accreditation of foreign manufacturers by the Minister, with the PMDA inspecting structure and equipment | Sourced | Reference 16 https://www.pmda.go.jp/review-services/drug-reviews/foreign-mfr/0011.html |
| The four types of institution, and the diagram of the division of roles | Our calculation | Our own classification and diagram (drawn from references 1, 2, 3 and 14) |
| The quality documentation required of materials depending on the customer | Inference | This article's reading of the procedural differences between the two routes in references 1 and 7 |
| The move from conditional and time-limited approval to full approval becoming the focus of the system | Inference | This article's reading of references 12 and 13 |
| Whether the two products approved in March 2026 win full approval within their time limits | Not yet confirmed | This article has not verified each product's time limit or approval conditions |
| Whether ReHeart was in fact listed (planned for 1 September 2026) | Not yet confirmed | Reference 11 says only that listing is planned; this article has not verified it |
| Staff numbers or budget for regenerative medicine alone | Not yet confirmed | No separate figure in references 4 and 5; this article does not estimate them |
Last updated 1 October 2026 / Troy Technical
All figures come from the official websites and published documents of the MHLW and the PMDA. Items marked "Inference" are this article's reading of the primary information. This article is not medical advice.