A total of 43 innovative new medicines are anticipated to be approved or listed in Japan this year, according to a survey by Jiho. At the center of attention are some highly innovative, but probably ultra-expensive, gene therapies, as well…
REGULATORY
MHLW to Make Case-by-Case Decisions on Use of “Specified Clinical Research” Data in Regulatory Filings
The Ministry of Health, Labor and Welfare (MHLW) will make decisions on whether to allow the use of data from “specified clinical research” on a case-by-case basis, but only under certain conditions, such as when registrational trials are deemed infeasible,…
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