Japan’s health ministry approved a slew of new medicines on September 25 including multiple “first of its kind” products, among them being GlaxoSmithKline’s respiratory syncytial virus (RSV) vaccine Arexvy as well as Eisai’s Alzheimer’s therapy Leqembi (lecanemab).Arexvy became the first…
REGULATORY
PMDA Will Prosper by Promoting Review Work, Research, and Training Together: Chief Executive
With 2014 marking 10 years since the inception of the Pharmaceuticals and Medical Devices Agency (PMDA), Jiho interviewed Tatsuya Kondo, who has served as chief executive since 2008. Initially, his appointment to the post was met with surprise as he…
To read the full story
Related Article
- PMDA Chief Kondo to Step Down after 11 Years in Charge
March 25, 2019
REGULATORY
- NHO Data Now Available through PMDA’s MID-NET Database
October 3, 2023
- As Copay Debate Picks Up Steam, MHLW Floats 4 Ideas for Coverage Reform
October 2, 2023
- Japan Seeking Solutions as Lab Monkey Shortage, Price Surge Threaten to Stymie Drug Development
October 2, 2023
- MHLW Proposes Setting Key Drugs as Category Separated from Bundled Trades
September 29, 2023
- Guidelines Should Urge Drug Makers to Explain Solo-Wholesaler Decisions: Panel Members
September 29, 2023
“Time is the scarcest resource, and unless it is managed, nothing else can be managed.” - Peter DruckerSearching for the right candidate takes time… but how much time?The last thing you want is to waste time searching for the wrong…
A doctor member of the Central Social Insurance Medical Council (Chuikyo) on September 20 traded barbs with pharma leaders over…
The Ministry of Health, Labor and Welfare (MHLW) on September 19 proposed restructuring the Japanese generic industry by restricting the…
The Ministry of Health, Labor and Welfare (MHLW) plans to no longer require the implementation of additional PI clinical studies…
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…