REGULATORY

Certified Review Boards Will Be Required “at Around 50 Institutions” if Clinical Research Bill Passes: MHLW Director

July 15, 2016

- Only subscribers can save articles.
  
  Sign In
  
  Subscribe

The Ministry of Health, Labor and Welfare (MHLW) expects that “certified clinical research review boards” will need to be established at around 50 medical institutions around the country if a clinical research bill being discussed in the Diet passes into…

To read the full story

MHLW to Work with PMDA from an Early Stage to Build Clinical Innovation Network: Division Head
July 28, 2016

REGULATORY

Japan Approves AbbVie’s Aquipta, Novo’s IcoSema, Pfizer’s Tukysa, and More
February 20, 2026
Health Minister Signals Early March Approval for iPSC Products
February 20, 2026
Takaichi Urges Public-Private Investment Push in Drug Discovery
February 20, 2026
Two iPSC-Derived Products Now in Line for Conditional Approval
February 20, 2026
PM Takaichi Keeps Cabinet Intact after Lower House Vote
February 18, 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…

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…

COMMENTARY

Hisamitsu’s MBO: Is Shareholder Accountability Trust-Building or a Shackle?

By Hayate Horiguchi

Following Hisamitsu Pharmaceutical’s decision to go private through a roughly 400 billion yen management buyout (MBO), industry observers are weighing…