Japan’s recent Upper House election delivered a stinging defeat for the ruling Liberal Democratic Party (LDP) and junior coalition partner…
REGULATORY
PMDA’s Next 5-Year Plan to Embrace New Generic Unit, Benchmarks for Review Time
The Pharmaceuticals and Medical Devices Agency (PMDA) intends to stipulate the establishment of a generic review unit and targets for the overall review time for generics and new drugs in its next five-year plan starting in April. A draft for…
To read the full story
Related Article
- PMDA Looks to New Pre-Application Meetings to Shed Review Time
November 14, 2014
REGULATORY
- PMDA Stresses Science-Based Decisions on Japanese PI Waivers: Symposium
August 5, 2025
- MHLW Trial Office Head Vows to Make Japan a Preferred Site for Clinical Studies
August 5, 2025
- MHLW Official Urges Use of New Fund to Drive Reorganization of Generic Sector
August 4, 2025
- MHLW Issues Guidance on Clinical Trial Design for Radiopharmaceuticals
August 4, 2025
- Wage-Based Price Premiums on Drugs Not an Option, Says MHLW Insurance Chief
August 4, 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…