The roadmap to approval under Japan's two-track regulatory system: comparing six regenerative medical products
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The PMD Act introduces a conditional and time-limited approval system for regenerative medical products, allowing these therapies to reach the market more quickly, with products conditionally approved based on preliminary safety and efficacy data and full approval contingent upon further validation.
“The PMD Act introduces a conditional and time-limited approval system for regenerative medical products, allowing these therapies to reach the market more quickly”
From Brief summary of the regulatory frameworks of regenerative medicine therapies (2025) · cites this paper as Matsushita et al., 2020
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- [2]2. Cyranoski, D. Japan’s approval of stem-cell treatment for spinal-cord injury concerns scientists Nature. 2019; 565:544-545 Crossref Scopus (45) PubMed Google Scholar
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Brief summary of the regulatory frameworks of regenerative medicine therapies
Yoon, J., Lee, S., Kim, M. J., & Kim, J.-H. (2025) · Frontiers in Pharmacology · doi:10.3389/fphar.2024.1486812 · Cited by 38 · see citing works
- Authors
- Matsushita, S., Tachibana, K., Kusakabe, T., Hirayama, R., Tsutsumi, Y., & Kondoh, M.
- Venue
- Cell Stem Cell
- Publisher
- Elsevier BV
- Published
- 2020-10
- Volume
- 27
- Issue
- 4
- Pages
- 515-518
- ISSN
- 1934-5909
- Cited by
- 10
- References
- 0
- Language
- en
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