The Ministry of Health, Labor and Welfare (MHLW) appears to be ready to begin post-launch drug price adjustments based on cost-effectiveness assessments (CEAs) for the first time since the system was introduced in April 2019. As price tweaks will be…
REGULATORY
Lower House Passes Immunization Act Amendment Bill
The Lower House of the Diet passed a draft bill to amend the Immunization Act/Quarantine Act at its plenary meeting on November 19, sending it to the Upper House for its deliberations from November 20. At the plenary session, Naomi…
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Biogen’s controversial Alzheimer’s drug aducanumab was filed for Japanese regulatory approval in December. If approved, it will be the first…
Japan’s key reimbursement policy panel on December 20 approved an outline of its FY2020 drug pricing reform next April, with…
The Ministry of Health, Labor and Welfare (MHLW) on November 27 added to the NHI price list Japan’s first biosimilars of Avastin (bevacizumab), Nesp (darbepoetin alfa), and Forteo (teriparatide). The NHI prices of first biosimilars are set at 70% of…
Japan will go ahead with the introduction of a cost-effectiveness assessment (CEA) scheme for drugs and medical devices in April…
It has been just over one year since the start of the COVID-19 pandemic. Much has been written in Japan about COVID-19’s effect on life science manufacturers’ customer engagement model. How can Japan, with its continued reliance on the traditional…