A total of 43 innovative new medicines are anticipated to be approved or listed in Japan this year, according to a survey by Jiho. At the center of attention are some highly innovative, but probably ultra-expensive, gene therapies, as well…
REGULATORY
MHLW Issues ICH E19-Based Guideline on Selective Approach to Safety Data Collection in Clinical Trials
The Ministry of Health, Labor and Welfare (MHLW) has issued a new guideline on safety data collection from late-stage and post-registration clinical trials. Based on the ICH’s E19 Guideline, the new guidance is expected to facilitate the efficient conduct of…
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REGULATORY
- Minimum NHI Prices to Be Raised by 3% Across the Board on April 1
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- Govt Must Not Let Pro-Innovation Reform of 2024 Go to Waste: Sr Vice Minister
January 15, 2025
- Nothing Decided on Drug Discovery Support Fund: Minister
January 15, 2025
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A Japanese health ministry panel on December 26 wrapped up its discussions on the next amendment of the Pharmaceuticals and…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
In a recent conversation with James Feliciano, former president of AbbVie Japan, we delved into the intricacies of leadership in the Japanese pharmaceutical industry. Feliciano, a seasoned industry veteran, shared valuable insights into his experiences, challenges, and successes.Navigating the Abbott…
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…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…