Japan’s recent Upper House election delivered a stinging defeat for the ruling Liberal Democratic Party (LDP) and junior coalition partner…
REGULATORY
Roughly 60 Products Submitted as Candidates for Review under Sakigake Designation System
Drug makers have put forward around 60 products as candidates for review under what the Ministry of Health, Labor and Welfare (MHLW) calls the “sakigake” designation system, Jiho has learned. The products that ultimately receive designation are expected to be…
To read the full story
Related Article
- Commentary: 1st Sakigake Drugs Picked via “Comparative Evaluation”, Will All Qualified Products Get Designated in the Future?
October 28, 2015
- Keytruda, Novel Anti-Flu Drug Join Japan’s First Sakigake Designation List
October 28, 2015
- 6 Drugs Get Sakigake Designation for Fast-Track Review
October 27, 2015
- MHLW Likely to Announce 5 or So Sakigake Products Next Week
October 22, 2015
- 51 Products Officially Filed for Sakigake Designation after MHLW Screening
September 18, 2015
- LDP Eyes Filing of 15 Sakigake Designated Products by FY2018
June 9, 2015
REGULATORY
- Japan Panel OKs Taisho’s Insomnia Med, 2 Other NMEs for Approval
August 1, 2025
- MHLW Selects 20 Organizations to Bolster Drug Discovery Clusters
August 1, 2025
- MHLW Orders Label Revisions for Semaglutide, Tirzepatide to Include Ileus Risk
July 31, 2025
- 23 Suspected Promotional Violations Identified for 18 Drugs in FY2024: MHLW
July 31, 2025
- MHLW Panel to Further Review Positioning of Susmed’s Insomnia App
July 31, 2025
A recent conversation with a US biopharma senior director highlighted a critical talent gap: a strong demand for individuals with strategic management, critical thinking, and advanced business acumen-skills beyond traditional operational excellence. After the conversation, I rushed home and picked…
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…
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…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…