The Roadmap to Approval under Japan’s Two-Track Regulatory System: Comparing Six Regenerative Medical Products

The Japanese conditional and time-limited (CTL) approval framework, a tiered system for regenerative medical products, was initiated in 2014. Here, we compare the dossiers of six regenerative medical products with either direct full approval or CTL approval, and we discuss the regulatory considerati...

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Bibliographic Details
Published in:Cell stem cell 2020-10, Vol.27 (4), p.515-518
Main Authors: Matsushita, Shunsuke, Tachibana, Keisuke, Kusakabe, Tetsuya, Hirayama, Ryuichi, Tsutsumi, Yasuo, Kondoh, Masuo
Format: Article
Language:English
Subjects:
Japan
Regenerative Medicine
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Summary:The Japanese conditional and time-limited (CTL) approval framework, a tiered system for regenerative medical products, was initiated in 2014. Here, we compare the dossiers of six regenerative medical products with either direct full approval or CTL approval, and we discuss the regulatory considerations for obtaining approval under the CTL approval framework. The Japanese conditional and time-limited (CTL) approval framework, a tiered system for regenerative medical products, was initiated in 2014. Here, we compare the dossiers of six regenerative medical products with either direct full approval or CTL approval, and we discuss the regulatory considerations for obtaining approval under the CTL approval framework.
ISSN:1934-5909
1875-9777
DOI:10.1016/j.stem.2020.09.003