Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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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