Three Approaches to Accessing the Japanese Market
An informative article in ASCPT’s Clinical and Translational Science from NOVARTIS was recently published, analyzing three approaches to accessing the Japanese market: the Japanese Phase I waiver, the first-in-human study conducted in Japan, and multifunctional Japanese Phase I studies. “Reimagining Early-Phase Clinical Development in Japan: From Regulatory Obligation to Global Acceleration” Further analysis of cycle times emphasizes Japan’s globally competitive timelines, as “a key location for first-in-human and early phase trials.” For those interested in...