The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
Risk Management Plans for 8 APIs Published Since April 2013; Will Be Required for Approval of New Drugs and Biosimilars Starting October 1, 2014
More than a year has passed since the introduction of drug risk management plans (RMPs) in order to assess risks from the development phase through the post-marketing phase and help ensure drug safety. RMPs for a total of eight active…
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REGULATORY
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Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…