INSTITUTION PROFILE / CELL CULTURE TECHNOLOGY
PMDA
The agency that reviews cell products for the Japanese market and inspects the sites that make them
PMDA, the Pharmaceuticals and Medical Devices Agency, is an incorporated administrative agency (a government-owned body that is not itself a ministry) overseen by Japan's Ministry of Health, Labour and Welfare. It makes neither medicines nor cells. Its job is to review the approval applications that companies submit, inspect the manufacturing sites where the products are made, and report the results to the Minister of Health, Labour and Welfare. Any product that is to be sold in Japan goes through this review and inspection, whether it is a regenerative medicine product such as an iPS cell-derived therapy or a CAR-T cell product, or a biopharmaceutical such as an antibody drug that is manufactured by cell culture. This profile looks at one question only: how much influence PMDA actually has over cell culture technology.
What this article covers
- PMDA 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)
- Products and companies that have been through its review
- Outlook
- Glossary, references and claim-to-source audit
1. PMDA in 30 seconds
FULL NAMEPharmaceuticals and Medical Devices AgencyAn incorporated administrative agency
COUNTRYJapanHeadquarters in Kasumigaseki, Chiyoda-ku, Tokyo, with branches in Kansai and Hokuriku
TYPE OF BODYIncorporated administrative agencyOverseen by the Ministry of Health, Labour and Welfare. Not a government ministry
ESTABLISHED1 April 2004Took over the work of three bodies, including the national review centre
STAFF1,053All staff, as of 1 April 2025
ROLE IN CELL CULTUREReview and site inspectionReviews regenerative medicine products; runs GCTP and GMP inspections
REACHThe Japanese marketOverseas sites that make products for Japan are also inspected
OFFICES ABROADThailand and the U.S.Asia Office opened July 2024; Washington D.C. Office opened November 2024
The one thing to grasp first
PMDA reviews products; it does not approve them. Japan's main pharmaceutical law, the PMD Act, says that marketing a regenerative medicine product requires "the approval of the Minister of Health, Labour and Welfare" (Article 23-25). It then says the minister may have PMDA carry out the review and inspection, in which case the minister does not review the product himself or herself but grants approval taking into account the results that PMDA reports (Article 23-27) Sourced. The final decision therefore sits with the minister, but the hands-on work of reading the application dossier and going out to inspect the manufacturing sites is done by PMDA.
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
Five parts of PMDA's work bear on cell culture technology Sourced.
| Function | What it involves | Track record and scope |
|---|---|---|
| Review of regenerative medicine products | Reviews the quality, efficacy and safety of products that use living cells or genes. This includes reviews for conditional and time-limited approval, a pathway designed for products whose quality is hard to keep uniform | For products approved in FY2025 (April 2025 to March 2026), the median total review time was 8.9 months for priority products and 11.1 months for standard products |
| Clinical trial and development consultations | Advises companies, universities and research institutions developing medical products on trial design and on the data needed for an application | Covers regenerative medicine products as well as medicines |
| GCTP compliance inspections | Checks, on paper and on site, whether a regenerative medicine product manufacturing site meets GCTP, the Japanese manufacturing and quality control standard for these products | Covers sites in Japan and abroad. Eight on-site inspections in FY2025 (three overseas, five in Japan) |
| GMP compliance inspections (biopharmaceuticals) | Checks whether sites making medicines produced with cell culture technology, or recombinant medicines, comply with GMP | In Japan, sites making biological products and similar; abroad, sites making medicines (other domestic sites are inspected by prefectural governments) |
| Inspection of cell processing facilities | Under the Act on the Safety of Regenerative Medicine, examines the buildings and equipment of facilities that process cells for medical institutions (known as facilities for manufacturing specified processed cells), and carries out on-site inspections | A May 2025 amendment to the act widened its scope, and in FY2025 PMDA began inspecting the newly covered facilities |
A materials engineer's view: it is the manufacturing site that gets inspected
PMDA describes the scope of GCTP inspections as "manufacturing sites in Japan and abroad that make regenerative medicine products". Nothing in that description says the makers of culture media, culture equipment or single-use bags are themselves subject to inspection Sourced. A manufacturing site will not pass, however, unless it can explain how it controls manufacturing and quality, including the materials it uses. For a materials supplier, PMDA's influence therefore arrives indirectly, through its customers' manufacturing sites Our calculation.
4. How far its influence reaches (powers and geography)
| Aspect | What PMDA has | What it does not have |
|---|---|---|
| Powers | Review of application dossiers and document-based and on-site inspection of manufacturing sites. It reports the results to the Minister of Health, Labour and Welfare | The power to grant approvals or licences, which belongs to the minister. The power to set the price paid under public health insurance, which belongs to MHLW and the Central Social Insurance Medical Council (Chuikyo) |
| Geography | The Japanese market. For products exported to Japan, overseas manufacturing sites are also subject to GCTP and GMP inspection | Any power over approval or sales in other countries |
| International ties | Takes part in ICH (the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) as one of Japan's regulatory representatives. Joined PIC/S (the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) in July 2014, together with MHLW as a single participating authority | The power to set international guidelines on its own (ICH guidelines are agreed between regulators and industry) |
| Scale | 1,053 staff (as of 1 April 2025). Headquarters in Tokyo and branches in Kansai and Hokuriku; offices abroad in Thailand and Washington D.C. | The annual performance report gives no separate figure for staff working only on regenerative medicine products |
Why it is not purely a domestic body
PMDA's powers come from Japanese law, so in principle its reach stops at Japan's borders. For a company that makes abroad a product it wants to sell in Japan, though, it means PMDA inspectors visiting its overseas plant. Three of the eight on-site GCTP inspections in FY2025 were overseas Sourced. PMDA also exchanges inspection results with other regulators under the PIC/S framework (in FY2025 it provided the results of six GMP inspections, among other material, to other authorities) Sourced.
5. Products and companies that have been through its review
Main cell-based products reviewed in FY2025 and FY2026
| Product (company) | Date and type of approval | What it is (summarised from PMDA's list) | Link to this series |
|---|---|---|---|
| Amchepry (Sumitomo Pharma) | 6 March 2026 Conditional and time-limited approval | Clusters of dopaminergic neural progenitor cells, made by culturing and differentiating iPS cells derived from a healthy adult's blood. Used to improve the motor symptoms of Parkinson's disease. A SAKIGAKE-designated product (a Japanese fast-track scheme) | See our Sumitomo Pharma profile |
| Reheart (Cuorips) | 6 March 2026 Conditional and time-limited approval | Sheets of cardiomyocytes differentiated from allogeneic iPS cells. Used for severe heart failure caused by ischaemic cardiomyopathy | Not covered in this series |
| Allostem Sheet (Ishin Pharma) | 3 April 2026 Approval | Mesenchymal stem cells taken from a healthy adult's subcutaneous fat, cultured and formed into a sheet. Used for epidermolysis bullosa | Not covered in this series |
| Savyscus Injection (FUJIFILM Toyama Chemical) | 8 May 2026 Approval | A suspension of mesenchymal stem cells cultured from synovial tissue taken from the patient's own knee. Used for meniscal injury | Not covered in this series (a different FUJIFILM group company from the ones we profile) |
| Akuugo Suspension for Intracranial Implantation (SanBio) | 8 December 2025 Partial change approval | Received conditional and time-limited approval in July 2024. Once the comparability of the commercial product with the product used in clinical trials had been assessed, the approval condition that it "not be shipped until approved" was removed | Not covered in this series |
The Akuugo case shows that PMDA's review goes as far as asking whether the quality of the cultured cells is the same as in the clinical trials. With products made by culturing cells, even a small change in the way they are made can change the product.
6. Outlook
| What the evidence suggests | Primary information it rests on | Category |
|---|---|---|
| The two iPS cell-derived products will have to apply for approval again within their time limit and go back through PMDA review. Whether they can demonstrate efficacy at that point is the next major hurdle | Article 23-26 of the PMD Act limits a conditional and time-limited approval to no more than seven years (extendable by up to three) and requires a fresh application within that period. Both products were approved in March 2026 | Inference |
| Inspections of facilities that process cells for medical institutions will become a growing part of PMDA's work | The May 2025 amendment to the Act on the Safety of Regenerative Medicine widened its scope, and PMDA began inspecting the newly covered facilities in FY2025 | Inference |
| The more cell products are made abroad, the more weight PMDA's inspections of overseas sites will carry | GCTP inspections cover sites in Japan and abroad, and three of the eight on-site inspections in FY2025 were overseas. PMDA opened offices in Thailand and the U.S. in 2024 | Inference |
7. Glossary
- Regenerative medicine product
- A product made by processing living human or animal cells or tissue, or a gene therapy product. Japan's PMD Act treats these as a category of their own, separate from medicines and medical devices.
- Conditional and time-limited approval
- A scheme for regenerative medicine products whose quality is not uniform. If efficacy is presumed and safety is confirmed, the product can be approved early with conditions and a time limit of no more than seven years. The company must apply again within that period.
- GCTP
- Good Gene, Cellular, and Tissue-based Products Manufacturing Practice: Japan's standard for manufacturing and quality control of regenerative medicine products, the counterpart of GMP for medicines (see our explainer on GMP).
- Specified processed cells
- Cells that have been cultured or otherwise processed for use in regenerative medicine at a medical institution, but that are not an approved regenerative medicine product.
- PIC/S
- An international framework through which regulators cooperate on GMP inspections of medicines. For Japan, MHLW and PMDA together form one participating authority.
8. References
- PMDA About PMDA (in Japanese): name, establishment, legal status and functions. https://www.pmda.go.jp/about-pmda/outline/0001.html
- PMDA Agency guide (in Japanese, published May 2025): status as an incorporated administrative agency overseen by MHLW, the conditional and time-limited approval scheme, the definition of GCTP, the Kansai and Hokuriku branches, and the opening of the Asia Office and the Washington D.C. Office. https://www.pmda.go.jp/files/000219906.pdf
- PMDA Annual performance report for FY2025 (in Japanese): location, total staff, total review times for regenerative medicine products, the number of on-site GCTP inspections, the start of inspections of facilities for manufacturing specified processed cells, and inspection results provided under PIC/S. https://www.pmda.go.jp/files/000282524.pdf
- PMDA GMP/QMS/GCTP compliance inspections (in Japanese): the division of work between PMDA, prefectural governments and third-party certification bodies, and GCTP inspections covering sites in Japan and abroad. https://www.pmda.go.jp/review-services/gmp-qms-gctp/0001.html
- PMDA Compliance inspections under the Act on the Safety of Regenerative Medicine (in Japanese): inspection of the buildings and equipment of facilities for manufacturing specified processed cells, and on-site inspections. https://www.pmda.go.jp/review-services/gmp-qms-gctp/ensure-safety-regen/0001.html
- PMDA List of regenerative medicine products approved in FY2025 (in Japanese): Akuugo, Reheart, Amchepry and others. https://www.pmda.go.jp/files/000280052.pdf
- PMDA List of regenerative medicine products approved in FY2026 (in Japanese): Allostem Sheet, Savyscus Injection and others. https://www.pmda.go.jp/files/000282058.pdf
- e-Gov law database Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, the PMD Act (in Japanese): Article 23-25 (approval), Article 23-26 (conditional and time-limited approval) and Article 23-27 (review and other work by PMDA). https://laws.e-gov.go.jp/law/335AC0000000145
- e-Gov law database Act on the Safety of Regenerative Medicine (in Japanese): Article 35 (licence to manufacture specified processed cells), Article 38 (inspection by PMDA) and Article 53 (on-site inspection by PMDA). https://laws.e-gov.go.jp/law/425AC0000000085
- PMDA ICH, the International Council for Harmonisation (in Japanese): PMDA takes part as one of Japan's pharmaceutical regulatory representatives. https://www.pmda.go.jp/int-activities/int-harmony/ich/0014.html
- 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 |
|---|---|---|
| Full name, English name, establishment on 1 April 2004, and the merger of three bodies' work | Sourced | Reference 1 https://www.pmda.go.jp/about-pmda/outline/0001.html |
| Status as an incorporated administrative agency overseen by MHLW, the conditional and time-limited approval scheme, consultations covering regenerative medicine products, the Kansai and Hokuriku branches, and the Asia Office (July 2024) and Washington D.C. Office (November 2024) | Sourced | Reference 2 https://www.pmda.go.jp/files/000219906.pdf |
| 1,053 staff (1 April 2025), total review times of 8.9 months (priority) and 11.1 months (standard), eight on-site GCTP inspections (three overseas, five in Japan), the start of inspections of facilities for manufacturing specified processed cells, and six inspection results provided to other regulators | Sourced | Reference 3 https://www.pmda.go.jp/files/000282524.pdf |
| GCTP inspections cover sites in Japan and abroad; GMP inspections cover domestic sites making medicines produced with cell culture technology and similar, plus overseas sites; other sites fall to prefectural governments | Sourced | Reference 4 https://www.pmda.go.jp/review-services/gmp-qms-gctp/0001.html |
| Inspection of buildings and equipment at facilities for manufacturing specified processed cells, and on-site inspections | Sourced | Reference 5 https://www.pmda.go.jp/review-services/gmp-qms-gctp/ensure-safety-regen/0001.html |
| Conditional and time-limited approval of Amchepry and Reheart (6 March 2026), and Akuugo's partial change approval and the removal of its approval condition | Sourced | Reference 6 https://www.pmda.go.jp/files/000280052.pdf |
| Approval of Allostem Sheet (3 April 2026) and Savyscus Injection (8 May 2026) | Sourced | Reference 7 https://www.pmda.go.jp/files/000282058.pdf |
| Approval by the health minister; the minister may have PMDA carry out review and inspection and takes its results into account; the time limit on conditional and time-limited approval (no more than seven years, extendable by up to three) and the duty to reapply | Sourced | Reference 8 https://laws.e-gov.go.jp/law/335AC0000000145 |
| The licence to manufacture specified processed cells is granted by the health minister, who may have PMDA carry out inspections and on-site inspections | Sourced | Reference 9 https://laws.e-gov.go.jp/law/425AC0000000085 |
| Participation in ICH | Sourced | Reference 10 https://www.pmda.go.jp/int-activities/int-harmony/ich/0014.html |
| Accession to PIC/S (one participating authority together with MHLW, July 2014) | Sourced | Reference 11 https://picscheme.org/en/members |
| The four types of institution, and the selection of products in Fig. 2 | Our calculation | Our own classification (products chosen from references 6 and 7) |
| Influence on materials suppliers arrives indirectly, through manufacturing sites | Our calculation | This article's reading of the inspection scope set out in reference 4 |
| Number of staff working only on regenerative medicine products | Not yet confirmed | No separate figure in reference 3; this article does not estimate it |
| The three points in the outlook (section 6) | Inference | This article's reading of the rules and track record in references 2, 3 and 8 |
Last updated 24 September 2026 / Troy Technical
All figures come from PMDA's website, annual performance report and lists of approved products, and from the text of Japanese law in the e-Gov law database. Items marked "Inference" are this article's reading of the primary information, not statements by PMDA.