INSTITUTION PROFILE / CELL CULTURE TECHNOLOGY
Ministry of Health, Labour and Welfare
The ministry that decides whether a cell product may be sold in Japan, and what insurance pays for it
The Ministry of Health, Labour and Welfare (MHLW) is the Japanese government ministry responsible for healthcare, pensions, long-term care and employment. Cell culture technology is only a small part of its remit, but it holds three levers: approval of regenerative medicine products, the rules for regenerative medicine offered by hospitals and clinics, and the price paid under Japan's public health insurance. Because the hands-on review work is done by PMDA and the grant-making by AMED, this profile concentrates on the powers MHLW holds itself, and makes clear where the line with PMDA falls.
What this article covers
- MHLW 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)
- Two legal routes, and the products that have been priced
- Outlook
- Glossary, references and claim-to-source audit
1. MHLW in 30 seconds
FULL NAMEMinistry of Health, Labour and WelfareUsually abbreviated to MHLW
COUNTRYJapanHead office in Kasumigaseki, Chiyoda-ku, Tokyo
TYPE OF BODYGovernment ministryHolds statutory powers to license and approve
STAFF33,093 postsAuthorised headcount under the cabinet order on government staff numbers. Covers the whole ministry, including labour administration
BUDGET¥35.0433 trillionGeneral account, FY2026. Covers everything, including pensions, healthcare and long-term care
ROLE IN CELL CULTUREApproval, licensing, pricing, research fundsAdministers the PMD Act and the Act on the Safety of Regenerative Medicine
REACHJapanese healthcareExtends through accreditation to overseas manufacturers and processing facilities that supply Japan
CELL PROCESSING FACILITIES3,671Licensed and notified combined, plus 19 accredited overseas facilities (as of 30 June 2026)
The one thing to grasp first: how the work is split with PMDA
In law, approvals and licences are granted by the Minister of Health, Labour and Welfare. The PMD Act, Japan's main pharmaceutical law, says the minister may have PMDA review regenerative medicine products and inspect manufacturing sites, in which case the minister grants approval taking PMDA's results into account (Article 23-27). The Act on the Safety of Regenerative Medicine likewise says the minister may have PMDA carry out the inspections needed to license cell processing facilities, and on-site inspections (Articles 38 and 53) Sourced. In short, PMDA does the checking and MHLW makes the decision. Two things, however, are not PMDA's business at all and stay with MHLW: receiving regenerative medicine plans from hospitals and clinics, and setting the price paid by insurance.
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
MHLW has four mechanisms that bear on cell culture technology Sourced.
| Mechanism | What MHLW does | Figures and examples |
|---|---|---|
| PMD Act (regenerative medicine products) | Grants marketing approval, licenses marketing authorisation holders and manufacturers, and accredits overseas manufacturers that export to Japan. For products whose quality is not uniform, it can grant approval with conditions and a time limit of no more than seven years after hearing the Pharmaceutical Affairs Council, an advisory body to the ministry | On 6 March 2026, two iPS cell-derived products (Amchepry and Reheart) received conditional and time-limited approval |
| Act on the Safety of Regenerative Medicine (regenerative medicine at hospitals and clinics) | Receives the provision plan that a medical institution must file before offering regenerative medicine (except when an approved product is used exactly as approved). Each plan is first reviewed by a certified committee for regenerative medicine. Also licenses, receives notifications from, and accredits overseas facilities that process cells for medical institutions | As of 30 June 2026: 6,743 plans for treatment and 85 for research. Cell processing facilities: 85 licensed, 3,586 notified, 19 accredited overseas |
| Insurance price | Decides whether an approved regenerative medicine product is to be handled "like a medicine" or "like a medical device", then sets its price after deliberation by the Central Social Insurance Medical Council (Chuikyo), the body that advises on what Japan's public health insurance pays | Amchepry, handled like a medicine: ¥55,306,737 (per set of 18 vials). Reheart, handled like a medical device: ¥53,200,000 |
| Research funding | Distributes research money through AMED, and puts its own share of AMED's funded expenses into its budget | MHLW's share was ¥48.1 billion of the ¥123.8 billion in AMED-funded expenses for FY2026 (all fields) |
A materials engineer's view: the same cultured cells can fall under two different laws
Cells that a company sells as a product fall under the PMD Act; cells that a hospital or clinic prepares for each patient fall under the Act on the Safety of Regenerative Medicine. As of 30 June 2026 there were 3,671 facilities processing cells under the latter, licensed and notified combined, of which 3,586 were notified Sourced. Notification is open only to certain facilities, such as those located in hospitals and clinics or manufacturing sites that already hold a manufacturing licence under the PMD Act (Article 40 of the act). For makers of culture media and equipment, that means two groups of customers under different rules: a small number of sites making approved products, and a large number of processing facilities attached to hospitals and clinics Our calculation.
4. How far its influence reaches (powers and geography)
How powers are split with PMDA
| Procedure | MHLW (the Minister of Health, Labour and Welfare) | PMDA |
|---|---|---|
| Approval of regenerative medicine products | Grants approval (including conditional and time-limited approval) | Carries out the review and reports the results to the minister |
| Manufacturing site compliance | Manufacturing licences; accreditation of overseas manufacturers | GCTP inspections (on paper and on site, in Japan and abroad) |
| Cell processing facilities (under the Act on the Safety of Regenerative Medicine) | Licences to manufacture; accreditation of overseas facilities | Inspection of buildings and equipment for licensing; on-site inspections |
| Regenerative medicine at hospitals and clinics | Receives provision plans; carries out on-site inspections of medical institutions | The provisions allowing the minister to delegate work to PMDA cover only inspections of processing facilities |
| Insurance price | Sets the price after Chuikyo deliberation | Not part of its work |
Powers and geography
| Aspect | What MHLW has | What it does not have |
|---|---|---|
| Powers | Approvals, licences and accreditation; receiving regenerative medicine plans from medical institutions and inspecting them on site; insurance prices; research budgets | Any power over approval or pricing in other countries |
| Geography | Japanese healthcare. Its reach extends abroad, however, through accreditation of overseas manufacturers that make products for Japan, and of overseas facilities that process cells for regenerative medicine in Japan (19 accredited overseas facilities: 13 in South Korea, 3 in Taiwan, 1 in China, 1 in Austria and 1 in Greece) | Any power over overseas companies that do not sell into Japan |
| International ties | Joined PIC/S (the international cooperation scheme for GMP inspection) in July 2014, together with PMDA as a single participating authority | The power to set international guidelines on its own |
| Scale | 33,093 authorised posts; general account budget of ¥35.0433 trillion (FY2026) | Published documents give no separate headcount or budget for work on cell culture technology alone |
A note on reading the numbers
The 33,093 posts and the ¥35.0433 trillion general account budget are figures for the whole ministry, covering pensions, healthcare, long-term care, employment and more Sourced. In the outline of the FY2026 budget, regenerative medicine appears only as items such as "promoting the practical application of regenerative and cell medicine and gene therapy", inside a ¥7.1 billion heading for "improving the R&D environment and supporting the practical application of drug discovery seeds and medical devices". No amount is given for cell culture technology alone Not yet confirmed.
5. Two legal routes, and the products that have been priced
Cell-based products priced for insurance in 2026
| Product (company) | Approval | Insurance handling and price | Link to this series |
|---|---|---|---|
| Amchepry (Sumitomo Pharma) | 6 March 2026 Conditional and time-limited approval | Handled like a medicine. ¥55,306,737 (per set of 18 vials), presented to Chuikyo for listing on 20 May 2026 | See our Sumitomo Pharma profile |
| Reheart (Cuorips) | 6 March 2026 Conditional and time-limited approval | Handled like a medical device. ¥53,200,000, presented to Chuikyo for listing on 1 September 2026 | Not covered in this series |
| Akuugo Suspension for Intracranial Implantation (SanBio) | 31 July 2024 Conditional and time-limited approval | Handled like a medicine. ¥72,716,528 (per treatment), presented to Chuikyo for listing on 20 May 2026 | Not covered in this series |
| Allostem Sheet (Ishin Pharma) | 3 April 2026 Approval | Handled like a medicine. ¥182,096 (per 5 cm × 5 cm sheet) | Not covered in this series |
A product receives an insurance price even while it holds only conditional and time-limited approval. All four prices were calculated by the cost-accounting method, which builds the price up from the cost of making the product.
6. Outlook
| What the evidence suggests | Primary information it rests on | Category |
|---|---|---|
| Oversight is tightening on regenerative medicine offered by hospitals and clinics | On 31 July 2026 MHLW asked providers to carry out self-inspections of whether they were providing regenerative medicine appropriately, and on 2 September 2026 it opened a contact point for information and whistleblowing reports on regenerative medicine | Inference |
| The Act on the Safety of Regenerative Medicine now reaches beyond cell-based medicine to gene therapy, and the mix of notifications and plans will change as a result | With the amended act in force from 31 May 2025, gene therapy that does not use processed cells (in vivo gene therapy) and other treatments were brought into scope | Inference |
7. Glossary
- PMD Act
- The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. It sets the rules for approving and manufacturing the medicines, medical devices and regenerative medicine products that companies sell.
- Act on the Safety of Regenerative Medicine
- The law that sets the procedures for regenerative medicine offered by medical institutions (except where an approved product is used exactly as approved), and the rules for facilities that process cells. In force since November 2014.
- Certified committee for regenerative medicine
- A committee certified by the Minister of Health, Labour and Welfare. It reviews a medical institution's provision plan and gives its opinion on whether the treatment should go ahead.
- Central Social Insurance Medical Council (Chuikyo)
- An advisory council to MHLW. It deliberates on whether a regenerative medicine product should be covered by public health insurance and what should be paid for it.
8. References
- e-Gov law database 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. https://laws.e-gov.go.jp/law/335AC0000000145
- e-Gov law database Act on the Safety of Regenerative Medicine (in Japanese): Article 4 (provision plans), Article 24 (on-site inspections), Article 35 (licence to manufacture), Article 38 (inspection by PMDA), Article 39 (accreditation of overseas facilities), Article 40 (notification) and Article 53 (on-site inspection by PMDA). https://laws.e-gov.go.jp/law/425AC0000000085
- e-Gov law database Cabinet order on the fixed number of staff in government administrative organs (in Japanese): MHLW's authorised headcount of 33,093, reflecting the amendment in force from 31 July 2026. https://laws.e-gov.go.jp/law/344CO0000000121
- MHLW Regenerative and cell medicine and gene therapy (in Japanese): entry into force of the act and its amendment of 31 May 2025, updates, the responsible division and the ministry's address. https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iryou/saisei_iryou/index.html
- MHLW Status of implementation of the Act on the Safety of Regenerative Medicine (in Japanese, as of 30 June 2026): numbers of committees, cell processing facilities and provision plans, and overseas accredited facilities by country or region. https://www.mhlw.go.jp/content/001590173.pdf
- MHLW Outline of the FY2026 draft budget (in Japanese): general account of ¥35.0433 trillion and the items within the ¥7.1 billion heading for improving the R&D environment. The budget was enacted as proposed. https://www.mhlw.go.jp/wp/yosan/yosan/26syokanyosan/dl/01-01.pdf
- Cabinet Secretariat, Office of Healthcare Policy Key points of the FY2026 budget for medical R&D (in Japanese): ¥123.8 billion in AMED-funded expenses, of which ¥48.1 billion from MHLW. https://www.cas.go.jp/jp/seisakukaigi/kenkouiryou/iyakuhin/iyakuhinkyougikai_dai2/sanko3.pdf
- Central Social Insurance Medical Council General meeting material 11-1, insurance handling of regenerative medicine products (list) (in Japanese, 8 April 2026): proposal to handle Reheart as a medical device and Amchepry as a medicine. https://www.mhlw.go.jp/content/10808000/001687603.pdf
- Central Social Insurance Medical Council General meeting material 5, insurance coverage of regenerative medicine products (in Japanese, 13 May 2026): prices and pricing method for Akuugo and Amchepry. https://www.mhlw.go.jp/content/10808000/001699508.pdf
- Central Social Insurance Medical Council General meeting material 3, insurance coverage of regenerative medicine products (in Japanese, 8 July 2026): price and pricing method for Allostem Sheet. https://www.mhlw.go.jp/content/10808000/001719808.pdf
- Central Social Insurance Medical Council General meeting material 2, insurance coverage of regenerative medicine products (in Japanese, 22 July 2026): price and pricing method for Reheart. https://www.mhlw.go.jp/content/10808000/001726219.pdf
- Central Social Insurance Medical Council Insurance handling of regenerative medicine products (in Japanese, 26 January 2022): the arrangement agreed on 5 November 2014 to decide whether each product is handled like a medicine or like a medical device, with listing deliberated at a Chuikyo general meeting. https://www.mhlw.go.jp/content/12404000/000887194.pdf
- PMDA List of regenerative medicine products approved in FY2025 (in Japanese): conditional and time-limited approval of Amchepry and Reheart. https://www.pmda.go.jp/files/000280052.pdf
- PIC/S Members: Japan's MHLW and PMDA form one participating authority, accession July 2014. https://picscheme.org/en/members
9. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| Approval, licensing and accreditation of overseas manufacturers by the health minister; the minister may have PMDA carry out review and inspection and takes its results into account; conditional and time-limited approval (after hearing the Pharmaceutical Affairs Council, no more than seven years, extendable by up to three, with a duty to reapply) | Sourced | Reference 1 https://laws.e-gov.go.jp/law/335AC0000000145 |
| Submission of provision plans and the certified committee's opinion; on-site inspection of medical institutions; licensing, notification and overseas accreditation of cell processing facilities; delegation of inspections to PMDA limited to processing facilities | Sourced | Reference 2 https://laws.e-gov.go.jp/law/425AC0000000085 |
| MHLW's authorised headcount of 33,093 | Sourced | Reference 3 https://laws.e-gov.go.jp/law/344CO0000000121 |
| Entry into force of the act in November 2014, the amended act in force from 31 May 2025 (adding in vivo gene therapy), the request for self-inspections on 31 July 2026, the reporting contact point opened on 2 September 2026, and the ministry's address | Sourced | Reference 4 https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iryou/saisei_iryou/index.html |
| 6,743 treatment plans and 85 research plans; cell processing facilities: 85 licensed, 3,586 notified, 3,671 in total; 19 accredited overseas (13 in South Korea, 3 in Taiwan, 1 in China, 1 in Austria, 1 in Greece) | Sourced | Reference 5 https://www.mhlw.go.jp/content/001590173.pdf |
| General account of ¥35.0433 trillion (FY2026), and the ¥7.1 billion heading for improving the R&D environment and the items within it | Sourced | Reference 6 https://www.mhlw.go.jp/wp/yosan/yosan/26syokanyosan/dl/01-01.pdf |
| ¥123.8 billion in AMED-funded expenses, of which ¥48.1 billion from MHLW | Sourced | Reference 7 https://www.cas.go.jp/jp/seisakukaigi/kenkouiryou/iyakuhin/iyakuhinkyougikai_dai2/sanko3.pdf |
| Proposal to handle Reheart as a medical device and Amchepry, Akuugo and Allostem Sheet as medicines; Akuugo's conditional and time-limited approval (31 July 2024) | Sourced | Reference 8 https://www.mhlw.go.jp/content/10808000/001687603.pdf |
| Amchepry at ¥55,306,737 and Akuugo at ¥72,716,528, planned listing on 20 May 2026, cost-accounting method | Sourced | Reference 9 https://www.mhlw.go.jp/content/10808000/001699508.pdf |
| Allostem Sheet at ¥182,096, cost-accounting method | Sourced | Reference 10 https://www.mhlw.go.jp/content/10808000/001719808.pdf |
| Reheart at ¥53,200,000, planned listing on 1 September 2026, cost-accounting method | Sourced | Reference 11 https://www.mhlw.go.jp/content/10808000/001726219.pdf |
| Handling each regenerative medicine product like a medicine or like a medical device, with listing deliberated at a Chuikyo general meeting | Sourced | Reference 12 https://www.mhlw.go.jp/content/12404000/000887194.pdf |
| Conditional and time-limited approval of Amchepry and Reheart (6 March 2026) | Sourced | Reference 13 https://www.pmda.go.jp/files/000280052.pdf |
| Accession to PIC/S (one participating authority together with PMDA, July 2014), and the English name | Sourced | Reference 14 https://picscheme.org/en/members |
| The four types of institution, and the framing of Fig. 2 as two routes | Our calculation | Our own classification |
| Media and equipment makers face two groups of customers under different rules | Our calculation | This article's reading of references 2 and 5 |
| Headcount and budget for cell culture technology alone | Not yet confirmed | No separate figures in references 3 and 6; this article does not estimate them |
| The two points in the outlook (section 6) | Inference | This article's reading of the rules and recent moves in references 1 and 4 |
Last updated 24 September 2026 / Troy Technical
All figures come from the text of Japanese law in the e-Gov law database, documents published by MHLW and the Cabinet Secretariat, Central Social Insurance Medical Council materials and PMDA's lists of approved products. Items marked "Inference" are this article's reading of the primary information, not statements by MHLW.