Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Japan to Clarify Non-Clinical Data Waivers for Repurposed Drugs, Ease Sakigake Rules
Japan’s health ministry plans to clarify that developers of repurposed drugs can omit some non-clinical study data from regulatory filings, in a move aimed at encouraging the new uses of established active ingredients. The Ministry of Health, Labor and Welfare…
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