The Roadmap to Approval under Japan's Two-Track Regulatory System: Comparing Six Regenerative Medical Products.
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 33007235.
- Also identified by DOI 10.1016/j.stem.2020.09.003.
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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.
Medical subject headings
- Regenerative Medicine