REGULATORY
Panel OKs Withdrawal Rule for Conditional Nod, 2-Year Extension for Pediatric Data Protection towards PMD Act Amendment
A Japanese health ministry panel on October 3 endorsed a list of seven proposals related to regulatory reviews towards the next amendment of the Pharmaceuticals and Medical Devices (PMD) Act. At the centerpiece of the plans are measures to facilitate…
To read the full story
Related Article
- Japan Sets Up “Moderate-Risk” Post-Approval Change for Shorter Review
October 1, 2024
- Japan Eyes Withdrawal Rule for Conditional Approval, More Flexible Nods
June 10, 2024
- JPA Wary of FPMAJ Pitch to Allow Non-Pharmacists as Drug Production Managers
May 21, 2024
- Allow Use of OOS Autologous Cell Products via PMD Act Amendment: FIRM
May 21, 2024
- Pharma Industry Wants “Internationally Harmonized” Rules under PMD Act
May 20, 2024
- MHLW Panel Sets Topics for PMD Act Amendment; Pediatrics, Drug Loss on Agenda
April 19, 2024
- MHLW Panel to Draw Up Report by Year-End towards Amendment of PMD Act
February 13, 2024
REGULATORY
- Trump Signs Off on Up to 100% Tariffs on Drugs; Japan Rate Set at 15%
April 3, 2026
- Japan Launches Task Force to Secure Critical Supplies amid Middle East Crisis
April 3, 2026
- MHLW Streamlines Lot Release Procedures for Vaccines, Blood Products
April 3, 2026
- MHLW Allows Outer Packaging Labeling for Regenerative Medicine Products
April 3, 2026
- MHLW’s Drug Supply Monitoring System Now Up and Running
April 3, 2026
Strategic Talent Acquisition in the Japanese Life Sciences Sector: Your Market Intelligence Briefing
Focus: How to Get the Talent You Need in a Tough MarketThe Japanese life sciences sector presents a challenging landscape for global companies. To succeed, you must move beyond reactive hiring and adopt a truly strategic talent acquisition model. Our…





