REGULATORY

Japan Wants to Spur Regulatory Use of RWD, but Still Puts Weight on RCTs

By Ken Yoshino July 10, 2024

- Only subscribers can save articles.
  
  Sign In
  
  Subscribe

The regulatory filing based solely on real-world data (RWD) has been a major topic of the next amendment of the Pharmaceuticals and Medical Devices (PMD) Act. At this time, however, the health ministry does not believe that new drug submissions…

To read the full story

New ICH Topic on RWD to Be Proposed towards Its Use in Regulatory Review
July 2, 2024
MHLW Proposes Creating Legal Provision on RWD-Only Drug Submissions
June 10, 2024

REGULATORY

Japan to Delist 387 Drugs from NHI Price List, Including Renivace
February 16, 2026
Chuikyo Payers Signal Mixed Views on Off-Year Drug Price Revisions
February 16, 2026
Chuikyo Issues FY2026 Fee Revision Recommendation, Creates New Premiums for Generics and Biosimilars
February 16, 2026
Japan Panel to Review Sumitomo, Cuorips iPSC Products on Feb. 19
February 16, 2026
Update: DMD Gene Therapy Elevidys Cleared for NHI Listing at 305 Million Yen
February 13, 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

Is Calling for an Abolition the Right Play? Rethinking Japan’s FY2027 Off-Year Drug Price Revision

By Ken Yoshino

Japan’s health and finance ministers agreed late last year to go ahead with an “off-year” drug price revision in FY2027,…

COLUMN

AI in Healthcare Hiring: Leveling the Playing Field & Unlocking Human Potential

By Philip Carrigan

The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…