REGULATORY

MHLW Issues Q&A on Conditional Approval System

May 1, 2026
Japan’s health ministry has issued a Q&A document clarifying how the country’s revised conditional approval system for drugs will be operated, following earlier guidance on the amended Pharmaceuticals and Medical Devices (PMD) Act, which took effect on May 1. Under…

To read the full story

Related Article

REGULATORY

Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…

By Kohei Hori

Japan’s pharmaceutical industry could be on the verge of gaining a stronger voice in the Central Social Insurance Medical Council…

By Philip Carrigan

Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…

Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…

By Ken Yoshino

The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…

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 all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…