The Ministry of Health, Labor and Welfare (MHLW) on September 19 proposed restructuring the Japanese generic industry by restricting the…
REGULATORY
New Working Group to Propose Effective Collection and Sharing of Drug Supply Info by March-End
A new health ministry working group was launched on September 7 to discuss ways to more effectively collect and share drug supply information among stakeholders amid the long-drawn-out generic shortages. It aims to compile a proposal by the end of…
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REGULATORY
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As Japan moves into elaborate discussions on the potential reform of its cost-effectiveness assessment (CEA) in FY2024, members of a…
The Ministry of Health, Labor and Welfare (MHLW) plans to no longer require the implementation of additional PI clinical studies…
The Japanese government on September 12 approved Moderna’s updated monovalent COVID-19 vaccine directed at the Omicron XBB.1.5 strain, following its…
IntroductionCommercial transformation is a top priority for pharma leaders in Japan and rightfully so. In a market with low single…
In the run-up to FY2024 budget requests this summer, there were growing hopes in the pharmaceutical industry that the government's de-facto cap on increases in social security spending would finally be lifted. That did not happen, despite strong calls from…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…