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
- MHLW Details New Operational Rules for Conditional Approvals from May
March 3, 2026
- Japan’s Parliament Enacts Bill to Amend PMD Act
May 15, 2025
- PMD Act Set for Amendments Covering Issues Unaddressed over Past Decade: MHLW Official
February 4, 2025
- Panel OKs Withdrawal Rule for Conditional Nod, 2-Year Extension for Pediatric Data Protection towards PMD Act Amendment
October 4, 2024
REGULATORY
- Japan to Launch CEA “Technical Discussions” under MHLW Research Group
May 14, 2026
- Mounjaro Hit with 25% Price Cut under Japan’s “SPA-SSS” Re-Pricing
May 14, 2026
- Japan OKs Listing of Ambelvist, Dojolvi, Sohonos, and Finally Inrebic
May 14, 2026
- Chuikyo Clears NHI Listing for Amchepry, Akuugo, and Zolgensma Intrathecal
May 14, 2026
- Tepezza, Trodelvy Headed for NHI Price Cuts after CEAs
May 14, 2026
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…





