Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
REGULATORY
Panel Discusses Potential Waiver of Japanese Trials for Ultra-Orphan Medicines
A health ministry panel on pharmaceutical regulations on December 13 discussed the need for confirmatory trial data in Japanese subjects for drugs to treat ultra-rare diseases. The industry proposed waving the implementation of Japanese studies when deemed appropriate in a…
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