Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Risk Management Plans to Be Required from April 2013 to Strengthen Post-Marketing Safety Measures
Starting in April 2013, the Ministry of Health, Labor and Welfare (MHLW) will require pharmaceutical manufacturers to submit drug risk management plans (RMP) including risk minimization programs when submitting new drugs and biosimilars for approval and when new safety concerns…
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REGULATORY
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