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.

中文翻译：

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日本双轨监管制度下的审批路线图：比较六种再生医疗产品

日本的有条件限时 (CTL) 审批框架，即再生医疗产品的分级制度，于 2014 年启动。在这里，我们比较了直接完全批准或 CTL 批准的六种再生医疗产品的档案，并讨论了在 CTL 批准框架下获得批准的监管考虑。