Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Expedited Review Systems Now in Place in 3 Major Markets, but How Are They Different?
Three years after the US FDA launched its Breakthrough Therapy (BT) program, Japan introduced its sakigake designation system in 2015, albeit on a trial basis, followed by the EMA’s Priority Medicines (PRIME) scheme in March this year. All three are…
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REGULATORY
- MHLW to Set Criteria for Exemptions under OTC-Like Drug Charge Scheme
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- MHLW Reviewing EMIS Data on Petro-Product Supply to Medical Institutions
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