Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
JPA Wary of FPMAJ Pitch to Allow Non-Pharmacists as Drug Production Managers
The pharmaceutical industry has put forward a legal change to allow non-pharmacists to be designated as production managers at manufacturing sites, but a group of pharmacists urge caution on the proposal. The Federation of Pharmaceutical Manufacturers’ Associations of Japan (FPMAJ)…
To read the full story
Related Article
- Advisory Panel Backs Transfer of GMP Inspection Authority for New Generics to PMDA
November 5, 2024
- Panel OKs Withdrawal Rule for Conditional Nod, 2-Year Extension for Pediatric Data Protection towards PMD Act Amendment
October 4, 2024
- PMDA-Led Inspections Will Help Straighten Up Generic Makers: MHLW Councilor
September 6, 2024
- MHLW Panel to Draw Up Report by Year-End towards Amendment of PMD Act
February 13, 2024
REGULATORY
- Japan to Designate International Clinical Trial Hubs in FY2027
August 28, 2026
- MHLW Tax Reform Requests Cover Support for MCM Preparedness
August 28, 2026
- Patient Group Flags Risks of Inconsistent Decisions on OTC-Like Drug Charges
August 28, 2026
- MHLW Pharma Bureau Eyes 12 Billion Yen to Boost Plasma Product Production
August 28, 2026
- Novo, Lilly Want Reimbursement Support for Obesity Care: LDP Hearing
August 28, 2026
More than a year after Dupixent (dupilumab) became the first antibody therapy approved for COPD in Japan, drug makers are…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…