Japan Issues Draft Guidance On Microdosing
This article was originally published in PharmAsia News
Executive Summary
Japan's Ministry of Health, Labor and Welfare has issued a draft guidance on microdosing in an effort to encourage companies to make quicker development decisions related to early stage compounds. The draft guidance defines a microdose as a single dose of less than 1/100th of a dose of a test substance calculated to yield a pharmacologic effect, with a maximum dose of no more than100µgs. Microdosing has been implemented in both the U.S. and European Union; the draft guidance is the first such measure in Japan. The draft guidance is expected to be implemented in Japan as early as March; MHLW is accepting comments on the document until Feb. 8. (Click here for more.