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
Extension of Emergency Approval Period Would Be Allowed Only Once: MHLW Official
The approval period granted under the proposed emergency approval scheme - the centerpiece of a draft bill to amend the Pharmaceuticals and Medical Devices (PMD) Law now being discussed in the Diet - would be extended only once, a senior…
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