REGULATORY

PMDA Certified as APEC’s Training Center of Excellence for Regulatory Science

March 6, 2017

- Only subscribers can save articles.
  
  Sign In
  
  Subscribe

The Pharmaceuticals and Medical Devices Agency (PMDA) has been certified as an APEC Training Center of Excellence (CoE) for Regulatory Science in the areas of multi-regional clinical trials (MRCT)/GCP inspections and pharmacovigilance. The PMDA was given the title at a…

To read the full story

Kobe Univ. Aims to Become APEC “Center of Excellence”; Could Promote Stronger Japanese Role in Regulatory Harmonization
May 17, 2019

REGULATORY

MOF Pushes for Full-Scale FY2027 Off-Year Drug Price Revision Ahead of “Spring” Proposal
April 28, 2026
Japan Panel Backs Boehringer’s IPF Drug, Moderna COVID Vaccine
April 28, 2026
Japan Allows Flexibility on Pharmacopoeia Test Differences in Supply Crunch
April 28, 2026
Zepbound in Line for OSA Approval after Key Panel Nod
April 27, 2026
LDP Team Urges Patent-Period Price Maintenance, CEA Review in Growth Strategy Proposal
April 27, 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

Gene Therapies Expand into AMD, Raising Promise and Cost Concerns

By Shinya Sato

AAV (adeno-associated virus) gene therapies are moving beyond rare diseases into more prevalent conditions, with neovascular, or wet, age-related macular…

COLUMN

The Patient North Star: How Gilead Japan Redefined Innovation

By Philip Carrigan

In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…