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

Shunsuke Matsushita; Keisuke Tachibana; Tetsuya Kusakabe; Ryuichi Hirayama; Yasuo Tsutsumi; Masuo Kondoh

doi:10.1016/j.stem.2020.09.003

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

Cell Stem Cell. 2020 Oct 1;27(4):515-518. doi: 10.1016/j.stem.2020.09.003.

Authors

Shunsuke Matsushita¹, Keisuke Tachibana¹, Tetsuya Kusakabe², Ryuichi Hirayama³, Yasuo Tsutsumi¹, Masuo Kondoh⁴

Affiliations

¹ Graduate School of Pharmaceutical Sciences, Osaka University, Osaka 567-0871, Japan.
² Graduate School of Medicine, Osaka City University, Osaka 545-0051, Japan.
³ Graduate School of Medicine, Osaka University, Osaka 565-0871, Japan.
⁴ Graduate School of Pharmaceutical Sciences, Osaka University, Osaka 567-0871, Japan. Electronic address: masuo@phs.osaka-u.ac.jp.

PMID: 33007235
DOI: 10.1016/j.stem.2020.09.003

Abstract

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.

MeSH terms

Japan
Regenerative Medicine*