A year has passed since the Ministry of Health, Labor and Welfare (MHLW) announced its package strategy to fuel the early commercialization of software as a medical device (SaMD) in November last year. A growing number of drug makers are…
REGULATORY
COVID-19 Vaccine Label Revised to Warn of Myocarditis Risk in Young Men
The Ministry of Health, Labor and Welfare (MHLW) issued a notification on October 15 informing of label revisions for COVID-19 vaccines developed by Moderna and Pfizer regarding the risks of myocarditis and pericarditis in young men. The label revision follows…
To read the full story
Related Article
- 2 mRNA Jabs Ordered to Add Myocarditis to ADR List: Label Revision
December 6, 2021
- MHLW Panel OKs Use of Pfizer COVID-19 Jab for Moderna-Vaccinated Young Men
October 18, 2021
REGULATORY
- Shorter Booster Interval for All Citizens Difficult: Health Minister
December 8, 2021
- Written Pledge Rule on Generic Listing to Continue after 2021; Companies Feel Pressure for Stable Supplies
December 7, 2021
- BMS’ Second CAR-T Therapy Ide-Cel in Line for Approval in January
December 7, 2021
- MHLW to Prepare List of Priority Infectious Diseases by March-End, Set Up Study Group in December
December 7, 2021
- Japan Panels Agree to Add Myocarditis as ADRs for Pfizer, Moderna Vaccines
December 6, 2021
Remember what it was like back in March, when we all started working from home? There was a distinct change in the air - a sense of freedom and excitement about the novelty of being able to work from home.…
The average ratio of female employees at managerial posts stood at just 12.5% at pharmaceutical companies operating in Japan, a Jiho survey revealed. While foreign drug makers had an average 25.0%, the ratio came to as low as 9.8% for…
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…
Japan will go ahead with the introduction of a cost-effectiveness assessment (CEA) scheme for drugs and medical devices in April…