Descriptive Statistical Report on Japan's Regenerative Medicine Clinical Practice and Product Development
Analysis of 6,770 provision plans as of March 31, 2026 — 98.8% treatment-purpose, Type III dominant, 16 new PMDA trial notifications
1. Overview of Analysis and Significance of Advanced Regenerative Medicine
Advanced regenerative medicine encompasses cell therapy, gene therapy, and tissue engineering that use human cells to regenerate or restore bodily structure and function, or to treat disease. It holds transformative value in providing new therapeutic options for patients with severe, rare, and intractable conditions that lack alternative treatments. Article 4 of South Korea’s Advanced Regenerative Bioscience Act stipulates the state’s obligation to ensure that patients can readily access such technologies regardless of their socioeconomic status.
This report analyzes, from a descriptive statistical perspective, the clinical practice and treatment landscape governed by Japan’s Act on the Safety of Regenerative Medicine (hereinafter the Safety Act) and the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter the PMD Act). Following its regulatory reforms of 2014, Japan has operated a risk-stratified notification and acceptance system, and this report reflects the latest statistics as of March 31, 2026, as well as the status of South Korea’s amended law that came into effect on February 21, 2025.
2. Overall Summary (as of March 31, 2026)
Japan’s regenerative medicine ecosystem is systematically managed within the regulatory framework, with healthcare institutions providing cell-based technologies and companies submitting clinical trial plans for product development.
| Item | Result | Note |
|---|---|---|
| Total provision plans | 6,770 | As of March 31, 2026 |
| Treatment (private practice) plans | 6,686 | Approx. 98.8% of total |
| Research plans | 84 | Primarily Type I and Type II |
| PMDA processed cell first-time trial notifications | 16 | FY2024 |
| PMDA processed cell trial malfunction reports | 782 | FY2024 |
The most striking feature of Japan’s ecosystem is that approximately 98.8% of all provision plans were submitted and accepted for ‘treatment (private practice)’ purposes rather than research. This demonstrates that regenerative medicine technologies are being actively provided as clinical procedures within the regulatory framework.
3. Regulatory Background and Historical Context
3.1. Background to Japan’s ‘Three Regenerative Medicine Laws’
At the time of Professor Shinya Yamanaka’s Nobel Prize in 2012, Japan lagged behind in commercialization relative to its basic research capabilities. To address this, Japan established the ‘Three Regenerative Medicine Laws’ framework from 2013 onward: the Act for Promotion of Research and Development and Utilization of Advanced Regenerative Medical Products, the PMD Act (revised pharmaceuticals law), and the Regenerative Medicine Safety Act.
The Regenerative Medicine Safety Act classified ‘private-practice treatments’ and ‘clinical research’ conducted at healthcare institutions by risk level, and permitted outsourcing of cell culture to promote both speed and safety simultaneously.
3.2. South Korea’s Regulatory Changes: Effective February 21, 2025
South Korea amended its Advanced Regenerative Bioscience Act in February 2024, with the amended law coming into full effect on February 21, 2025. As a result, a system was introduced allowing technologies with established safety and efficacy evidence to be used not only for clinical research but also for patient treatment (advanced regenerative medicine treatment).
4. Classification of Regenerative Medicine and Provision Plans by Risk Level
Japan’s Ministry of Health, Labour and Welfare manages provision plan statistics stratified by risk level under the Safety Act.
| Category | Treatment (Private Practice) | Research | Total |
|---|---|---|---|
| Type I regenerative medicine | 8 | 10 | 18 |
| Type II regenerative medicine | 2,408 | 40 | 2,448 |
| Type III regenerative medicine | 4,270 | 34 | 4,304 |
| Cumulative total | 6,686 | 84 | 6,770 |
Type III regenerative medicine accounts for approximately 63.6% of the total, suggesting that minimally manipulated technologies such as PRP therapy have been widely disseminated to the level of general clinics.
5. PMDA Processed Cell Clinical Trial Plan Notification Status
Regenerative medicine products targeting commercialization must submit a ‘processed cell clinical trial plan’ notification to the PMDA. This is analogous in nature to South Korea’s Investigational New Drug (IND) approval, though Japan employs a notification system.
| Item (FY2024) | Notifications | Note |
|---|---|---|
| First-time trial plan notifications | 16 | New trial initiation (incl. 7 physician-initiated) |
| n-th trial plan notifications | 22 | Follow-on phases of existing trials, etc. |
| Trial plan amendment notifications | 276 | Protocol changes, etc. |
| Malfunction reports during trials | 782 | Safety monitoring results |
Approximately 44% of the 16 first-time trial notifications are physician-initiated trials, indicating that university hospitals are driving clinical trials at the pre-commercialization stage.
6. Key Regulatory Comparison: Institution Designation vs. Provision Plan Notification
| Aspect | South Korea (Institution Designation) | Japan (Provision Plan Notification) |
|---|---|---|
| Entry approach | Designation as ‘advanced regenerative medicine institution’ by Ministry of Health and Welfare | Notification and acceptance of plan meeting risk-stratified provision standards |
| Regulatory focus | Institutional qualification restriction prior to research initiation | Plan-level review and post-provision monitoring |
| Review body | Advanced Regenerative Medicine Review Committee | (Specific) Certified Regenerative Medicine, etc. Committee |
| Treatment permitted | Permitted from February 21, 2025 (amended law) | Permitted (as private practice) |
South Korea (institution designation system): Healthcare institutions wishing to conduct clinical research must first establish facilities and personnel, and receive designation as an ‘advanced regenerative medicine institution’ from the Ministry of Health and Welfare. This approach restricts institutional eligibility prior to research commencement.
Japan (provision plan notification system): Once a plan meeting the risk-stratified provision standards has been drafted and reviewed by a (specific) certified regenerative medicine committee, the procedure can be performed upon notification and acceptance. The focus is on plan-level review and post-provision monitoring rather than a separate institution designation system.
7. Latest Technology and Safety Management Trends (2025–2026)
| Trend | Details |
|---|---|
| iPS cell clinical application | On December 18, 2025, the world’s first administration of iPSC-derived T-cell therapy for cervical cancer was completed |
| Safety alert | On March 12, 2026, Japan’s Ministry of Health, Labour and Welfare issued a strong safety advisory circular to healthcare institutions on matters requiring attention when providing regenerative medicine |
| Administrative efficiency | From 2025, all application and reporting procedures were fully converted to online submission |
iPS cell clinical application: On December 18, 2025, the world’s first administration of iPSC-derived T-cell therapy for cervical cancer was completed, representing tangible progress in high-risk research.
Safety alert: On March 12, 2026, Japan’s Ministry of Health, Labour and Welfare issued a strong safety advisory to healthcare institutions on matters requiring attention when providing regenerative medicine, reinforcing safety management within the regulatory framework.
Administrative efficiency: From 2025, all application and reporting procedures were fully converted to online submission, improving the speed of administrative processing.
8. Conclusion
Japan has established a structure that accepts regenerative medicine broadly as a domain of ‘treatment’ rather than confining it to research, managing provision status and safety reporting within the regulatory framework. The figure of 6,770 provision plans as of March 2026 is the result of this approach. South Korea, where the amended law came into effect on February 21, 2025, should also reference Japan’s risk-stratified management system and safety guidelines to build an ecosystem in which treatment and research develop in harmony.
Appendix: Comparative Overview of Regenerative Medicine Regulatory Systems — Japan, Taiwan, and South Korea
Source: RMAF Insights, December 2023. No.4
| Aspect | Japan | Taiwan | South Korea |
|---|---|---|---|
| Governing law (year enacted) | Act on the Safety of Regenerative Medicine (‘14) | Regulations Governing the Implementation and Use of Specific Medical Technologies (‘18) | Advanced Regenerative Bioscience Act (‘20) |
| Competent authority | Ministry of Health, Labour and Welfare | Ministry of Health and Welfare | Ministry of Health and Welfare; MFDS |
| Nomenclature | Regenerative medicine provision (treatment, research) | Cell therapy technology | Advanced regenerative medicine clinical research |
| Definition | Technologies utilizing processed cell products | Therapeutic technologies using human cells/tissues | Cell/gene therapies using human cells, etc. |
| Classification | Type I / II / III (risk-stratified) | 6 types of cell therapy technology | High / moderate / low risk |
| Target population | Patients | Patients | Patients with severe, rare, or intractable conditions |
| Patient cost burden | Treatment: Yes; Research: No | Yes | No (treatment permitted from Feb. 21, 2025) |
| Implementing institution | Regenerative medicine provision institution (hospitals, clinics) | Medical institution (approved by MHW) | Advanced regenerative medicine institution (designated by MHW) |
| Review body | (Specific) Certified Regenerative Medicine, etc. Committee | Ministry of Health and Welfare | Advanced Regenerative Medicine Review Committee |
| Cell supply | Cell culture processing facility (licensed by MHLW) | Cell manufacturing facility (licensed by MHW) | Cell processing facility (licensed by MFDS) |
| Safety management | Committee reporting and MHLW reporting | Ministry of Health and Welfare | Advanced Regenerative Medicine Safety Management Institution |