REGULATORY

MHLW Mulls “Ultra-Orphan” Drug System; Designation Might Become Possible with Pre-Clinical, Healthy Subject Data

July 22, 2013
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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REGULATORY

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