Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
REGULATORY
MHLW to Clarify Criteria for Japanese PI Waivers through Q&A, Calls for Data-Based Justifications
Japan’s Ministry of Health, Labor and Welfare (MHLW) plans to issue a Q&A document to clarify when PI studies in Japanese subjects can be omitted before joining multi-regional clinical trials (MRCTs), according to the ministry’s drug review chief Tetsunari Kihira.…
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