REGULATORY

PMDA’s Next 5-Year Plan to Embrace New Generic Unit, Benchmarks for Review Time

February 5, 2014

- Only subscribers can save articles.
  
  Sign In
  
  Subscribe

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

PMDA Looks to New Pre-Application Meetings to Shed Review Time
November 14, 2014

REGULATORY

874 Defects or Health Damages Reported for Regenerative Medical Products in 1H FY2025
March 13, 2026
Chuikyo OKs Listing of J&J’s Rybrofaz, Peak Sales Seen at 43.8 Billion Yen
March 12, 2026
GSK’s Exdensur, Lilly’s Inluriyo Missing from March Listing Roster
March 12, 2026
Truqap Price Cut Set at 10.7% from June under CEA Scheme
March 12, 2026
Avelox Gains Coverage for MDR-TB via Public Knowledge Filing
March 12, 2026

Chuikyo Debate on FY2026 Drug Pricing Reform

Chuikyo OKs New CEA Handling, with Third-Party Verification Ahead

Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

COMMENTARY

Beyond Elevidys: Next-Generation DMD Therapies Advance through Multiple Approaches

By Shinya Sato

The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…

COLUMN

The Strategic MSL: Beyond Data Delivery, It’s About Impact

By Philip Carrigan

I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…