A Japanese health ministry proposal to impose steeper price cuts on certain medicines deemed to carry poor cost-effectiveness profiles cleared…
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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