Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
JGA President Opposes 50% Rule for Generics, CSIMC Subcommittee Members Disagree
Japan Generic Medicines Association (JGA) President Itsuro Yoshida raised objections to the health ministry’s proposal to set the NHI prices of first generic versions of a brand name drug at 50% of the original drug price, saying it would affect…
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REGULATORY
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International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…
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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…