Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
MHLW Issues ICH E19-Based Guideline on Selective Approach to Safety Data Collection in Clinical Trials
The Ministry of Health, Labor and Welfare (MHLW) has issued a new guideline on safety data collection from late-stage and post-registration clinical trials. Based on the ICH’s E19 Guideline, the new guidance is expected to facilitate the efficient conduct of…
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