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REGULATORY
- Make Onsite GMP Inspections Mandatory for Patented Meds and New Generics: MHLW Proposal
June 10, 2024
- MHLW Proposes Creating Legal Provision on RWD-Only Drug Submissions
June 10, 2024
- Japan Eyes Withdrawal Rule for Conditional Approval, More Flexible Nods
June 10, 2024
- LDP Policy Board Endorses Fiscal Consolidation HQ’s Proposal to Extend CEAs
June 10, 2024
- Japan Grants Orphan Tag to Cannabidiol, 6 More APIs
June 10, 2024
- Health-Savvy Lawmakers Urge Revamp of Off-Year Revisions: LDP Policy Panel
June 7, 2024
- Abolish Off-Year Revisions, No to Broader CEA Use: Eto Group to Ministers
June 7, 2024
- LDP League on Medical Patches Urges Clarification of “Medical Necessity” as New Coverage Rule Looms
June 7, 2024
- Japan Eases Rule on Regulatory Submissions for Combination Therapies
June 6, 2024
- Japan Health Ministry Panel Gives Blessing to Novartis’ PNH Drug Iptacopan and More
June 4, 2024
- Make Single IRB Mandatory in Multi-Center Trials That Use Competitive Funds: Deregulation Panel
June 4, 2024
- Finance Minister Acknowledges Wholesalers’ Plight with Frequent Drug Price Revisions
May 31, 2024
- Nitrosamine Guideline to Be Proposed as New Topic for ICH at Fukuoka Confab
May 31, 2024
- Expand Mixed-Billing Scheme to Cover Gene Panel Test: LDP Committee Proposal
May 31, 2024
- Japan Selects JN.1 for COVID-19 Vaccine Formula in 2024-2025 Season
May 30, 2024
- PMDA Cuts Fees for Pediatric, Orphan Drug Consultations
May 30, 2024
- LDP Lawmakers’ League on Generics Prods Minister to Rethink Off-Year Revisions
May 29, 2024
- Health Minister Acknowledges Changes after 2016 Decision on Off-Year Revisions
May 28, 2024
- MHLW Panel OKs Avigan for SFTS with Strings Attached, Shionogi COVID Jab Only for Primary Use
May 27, 2024
- LDP’s Social Security Commission Urges Govt to Revisit Off-Year Drug Price Revisions
May 24, 2024
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