The Ministry of Health, Labor and Welfare (MHLW) on November 29 proposed a more stringent application of the current 40% entry price rule for first oral generics towards the FY2024 drug pricing reform.Under the current rule, first oral generics are…
REGULATORY
Products Filed for Conditional OK Can Be Switched to Emergency Approval: MHLW Official
It would be possible to apply the proposed emergency approval pathway to products that have already been filed for conditional early approval if a bill to amend the Pharmaceuticals and Medical Devices (PMD) Law is enacted and enforced, a senior…
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