Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
REGULATORY
PMDA to Clarify Position on Japanese PI Trials at August Symposium amid Industry Confusion
A 2023 regulatory guidance on the need for Japanese PI trials prior to global studies appears to have led to some confusion in the industry. With some taking this as a blanket waiver, the Pharmaceuticals and Medical Devices Agency (PMDA)…
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