REGULATORY
Japan OKs Honebuto Paper with Softened Phrasing on CEA, Sign of Change to Social Security Budgeting
By Ken Yoshino June 16, 2025
Japan’s Cabinet approved the 2025 Basic Policy on Economic and Fiscal Management and Reform (honebuto) on June 13. The final paper kept the previous draft’s toned-down language on reforming the cost-effectiveness assessment (CEA) scheme, as…

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June 16, 2025
The Federation of Pharmaceutical Manufacturers’ Associations of Japan (FPMAJ) is urging the government to expand the scope of drugs that can be selected as comparators in the initial pricing of newly approved medicines as the…
June 16, 2025
The Federation of Pharmaceutical Manufacturers’ Associations of Japan (FPMAJ) is set to push for the exclusion of medicines qualified for the price maintenance premium (PMP) from drug price revisions as part of its requests towards…
June 16, 2025
Mitsubishi Tanabe Pharma said on June 13 that it has initiated a US PI/II trial of its novel bromodomain-containing protein 4 (BRD4) degrader MT-4561 for the treatment of advanced solid tumors. The company plans for…
By Philip Carrigan

The Japanese pharmaceutical industry, a vital component of global innovation, faces a talent gap that resonates across multinational corporations. While Japan possesses a wealth of highly skilled professionals, a notable communication disparity impedes recruitment and career advancement, particularly in global…

By Shinya Sato

Following the launch of two new therapies since last year, Japan has seen fresh moves in drug development for amyotrophic…

The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…

Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…

By Ken Yoshino

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…

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

The Ministry of Health, Labor and Welfare (MHLW) posted the final report compiled by its pharmaceutical regulation panel on its website on April 24, providing cases of drugs that could be exempted from all-case post marketing surveillance (PMS).The MHLW plans…

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…

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