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REGULATORY
- Legal Changes Needed to Push Use of Pseudonymized Data in Drug R&D: MHLW Working Group
January 16, 2024
- MHLW’s Planned Bill Would Exclude Certain Programs from “Specified Clinical Trials”
January 16, 2024
- MHLW Plans to Submit 4 Bills to This Year’s Ordinary Diet Session
January 16, 2024
- New LLP Coverage Rule Aimed to Transform Industry Rather Than Eke Out Savings: LDP Social Security Chief
January 15, 2024
- MHLW Issues Notification on Pediatric Development Plans
January 15, 2024
- Pharma Regulation Panel to Explore Potential Criteria for All-Case PMS Requirement
January 15, 2024
- Nobelpharma’s Hypozincemia Med, Jardiance’s CKD Use Up for PAFSC Review
January 15, 2024
- Japan Designates Noto Peninsula Quake as Severe Disaster
January 12, 2024
- MHLW Study Underway on Lab Monkey Shortage, Research Team Frets Dependence on Specific Sources
January 11, 2024
- MHLW Orders Label Revisions for Keytruda, Tecentriq, and More
January 11, 2024
- Handling of Big-Seller Candidates Is Top Priority as Japan Seeks Good Budget Balance: Minister
January 10, 2024
- Drugs Being Delivered to Quake-Hit Areas Day after Request: Minister
January 10, 2024
- Panels Urge OTC Switches “within 3 Years” for Drugs Sold Over the Counter in 2 or More Other Countries
January 5, 2024
- MHLW Unveils Draft Guidelines on Access to Intractable, Pediatric Disease Databases
January 5, 2024
- FY2024 Reform Heralds Shift to Funding Cycle within Drug Budget: MHLW Pharma Director
December 28, 2023
- Japan Sets Up New Pharma Forum to Fight Drug Lag/Loss, Aims to Reflect Proposals in Honebuto
December 28, 2023
- Payers Reiterate Their Push for “1/2” LLP Copay Scenario for Price Gap from Generics
December 28, 2023
- Chuikyo Officially OKs Application of Elective Care for Off-Patent Branded Drugs
December 28, 2023
- Japan Maps Out Fresh 10-Year Strategy for Cancer Research
December 28, 2023
- Regulatory Panel Members Want Clearer Standard for SaMD Efficacy in 2-Stage Approval Scheme
December 27, 2023
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Discussions by the Ministry of Health, Labor and Welfare’s (MHLW) study group on the generic industry structure are reaching the last lap. Its final report - a draft of which will be presented later this month - is expected to…
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