REGULATORY
MHLW Mulls “Ultra-Orphan” Drug System; Designation Might Become Possible with Pre-Clinical, Healthy Subject Data
The Ministry of Health, Labor and Welfare (MHLW) is set to begin discussions on bettering its current orphan drug designation system, including the creation of an “ultra-orphan drug” scheme to expedite designation for medicines that treat extremely rare diseases—based possibly…
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In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





