Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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REGULATORY
- Minister Touts “Balanced” Off-Year Revision after USCC Letter
February 19, 2025
- Espha’s Januvia Generic on Approval Roster towards June Listing
February 18, 2025
- “Annual Reports” Allowed for CMC Changes with Minimal Impact: MHLW
February 17, 2025
- Japan to Approve EquMet Generics, More Copycats toward June Listing
February 17, 2025
- MHLW Lays Out Procedures for Transition to Trivalent Flu Shots
February 17, 2025
- J&J’s Lazcluze, Genmab’s Tivdak, and More Up for MHLW Panel Review on Feb. 27
February 14, 2025
- Japan Cabinet Approves Bill to Amend PMD Act
February 13, 2025
- MHLW Not Yet Able to Examine Letters of Protest by US Lobbies: Minister
February 13, 2025
- Set Deadline for Non-Prescription Pilot of Morning-After Pill: Panel Members
February 13, 2025
- MHLW Panel Wary of Non-Prescription Switches for Diquas, Mucosta
February 13, 2025
- More Flu Drugs Returned than Supplied in Japan: Final Week of January
February 12, 2025
- PMDA to Modify Onsite GCP Inspections Based on Facility Track Records
February 10, 2025
- PMDA Reviewing Safety Risks for Immune Checkpoint Inhibitors, CAR-Ts
February 10, 2025
- Shionogi’s ADHD Game Therapy, CureApp’s Alcoholism App in Line for Approval
February 7, 2025
- Drug Ecosystem Budget Project Is for Private Sector: Minister
February 7, 2025
- Japan’s 1st Hemophilia B Gene Therapy Up for Panel Review on Feb. 19
February 6, 2025
- PMD Act Set for Amendments Covering Issues Unaddressed over Past Decade: MHLW Official
February 4, 2025
- Council OKs Public Knowledge Application for CellCept Label Expansion
February 3, 2025
- LDP OKs Govt’s 5-Year Healthcare Strategy with “Expanding Ecosystems” as Main Pillar
February 3, 2025
- Lixiana Now Set for Label Expansion; 11 Drugs to Get Orphan Tags
February 3, 2025
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