Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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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Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…