Graduate School of Pharmaceutical Sciences, Osaka University, Osaka 567-0871, Japan.
Graduate School of Medicine, Osaka City University, Osaka 545-0051, Japan.
Cell Stem Cell. 2020 Oct 1;27(4):515-518. doi: 10.1016/j.stem.2020.09.003.
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.
日本的有条件和限时（CTL）批准框架是一种用于再生医学产品的分层系统，于 2014 年启动。在这里，我们比较了六种具有直接完全批准或 CTL 批准的再生医学产品的档案，并讨论了在 CTL 批准框架下获得批准的监管考虑因素。
