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
Lower House Clears Bill to Amend Next-Gen Medical Infrastructure Law
Japan’s Lower House approved a draft bill to amend the next-generation medical infrastructure law on April 13, which would create a new category of data called “pseudonymized medical information” with a view to its use in regulatory submissions. The bill…
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