REGULATORY

MHLW Orders Label Revisions for SGLT2 Inhibitors, COVID Drugs, and More

By Takashi Ebisawa December 19, 2024
The Ministry of Health, Labor and Welfare (MHLW) on December 17 issued a notification ordering label revisions regarding safety risks for a slew of medicines, including a batch of SGLT2 inhibitors. Ketoacidosis has been a known side effect of SGLT2…

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REGULATORY

By Ken Yoshino

The Ministry of Health, Labor and Welfare (MHLW) on December 18 presented a proposal to define the scope of products…

By Ken Yoshino

Eli Lilly’s Kisunla (donanemab) will join the Japanese reimbursement list on November 20, with a health ministry panel giving the…

By Yoshinori Sagehashi

Will an “off-year” drug price revision happen in April 2025 or not? Over the last week, expectations have been up…

By Philip Carrigan

For 25 years, Morunda has been interviewing leaders in Japan’s pharmaceutical and medical device industry. Most country managers typically come from a commercial background, rooted in sales and marketing. It’s rare to find country managers who come from finance or…

A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…

A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…

Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…

By Yoshinori Sagehashi

The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…

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…