Oncology Dominates Japan Approvals, Though Overall Tally Is Lower
Although it approved fewer new products last fiscal year, Japan granted access to a number of important new therapies, including in oncology and several for the first time worldwide, helped by continuing reforms at its regulatory body.
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The foreign research-based pharma industry in Japan is continuing to ramp up warnings about what it sees as possible negative changes to Japan's currently "stable and predictable" pricing and operating environment, with the new chairman of US group PhRMA the latest to weigh in on the debate.
Japan's regulatory body will set up a new center next month to help in the training of other drug and device authorities across Asia, as part of its growing international activities.
The latest batch of product approvals in Japan includes the first regulatory clearances worldwide for new molecules from Merck and Shionogi, in a further sign that the country's "drug lag" is a thing of the past.