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
- MHLW’s Pharma Bureau to Request Budget to Promote RWD Use in Regulatory Filing for FY2023
August 26, 2022
- MHLW to Seek 400 Million Yen for AI-Powered Drug Discovery for Cancer: FY2023 Budget Request
August 26, 2022
- MHLW Seeks 2-Year Extension of Raise on R&D Tax Credit Ceiling: FY2023 Reform Request
August 26, 2022
- MHLW’s Health Policy Bureau Eyes COI Management System, Upgraded Clinical Research Database: FY2023 Budget Request
August 26, 2022
- MHLW to Request a 33.26 Trillion Yen General Account Budget for FY2023
August 26, 2022
- Lilly’s Tirzepatide in Line for Approval as Early as September as Japan’s 1st GIP/GLP-1 Agent
August 26, 2022
- Japan Approves Label Expansions for Lynparza, Ultomiris, Keytruda, Tagrisso, and More
August 25, 2022
- 1st Meeting of New Drug Distribution and Pricing Panel Set for Aug. 31
August 25, 2022
- AstraZeneca’s COVID Cocktail Up for Aug. 29 PAFSC Session; Comirnaty Pediatric Booster Too
August 23, 2022
- MHLW to Seek Budget for Integrated Drug Supply Info System for FY2023
August 23, 2022
- MHLW to Boost Orphan Program to Fuel New Drug Development: FY2023 Budget Request
August 23, 2022
- After Repeated Scandals, PMDA Sets Up New Division to Provide GMP Inspection Know-How to Prefectures
August 22, 2022
- Study Group Agrees on Need to Craft Transparent Rules for Use of Pseudonymized Info
August 22, 2022
- Operational Issues of Emergency Approval Scheme Will Be Addressed If Needed: Pharma Bureau Chief
August 19, 2022
- New Panel on Drug Distribution and Pricing Likely to Launch on Aug. 31
August 18, 2022
- AZ’s Asthma Drug Tezepelumab Up for MHLW Panel Review on August 29
August 17, 2022
- Generic Makers Flock to Samsca’s Heart Failure Market after Patent Invalidated; Gx Listing Expected in December
August 16, 2022
- Authorized Generics Approved for Nexium, Samsca, Lipitor, Careram
August 16, 2022
- First Generics for 5 APIs Approved towards December Listing, with 8 Firms for Nexium
August 16, 2022
- MHLW Leaks Personal Info on Intractable Disease Patients
August 16, 2022
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