In late January, a bill to amend the Pharmaceuticals and Medical Devices Act cleared key legislation review processes by the…
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REGULATORY
- PMDA Reviewing Safety Risks for Duvroq, Opdivo, and More
June 24, 2024
- Japan Panel Raises No Objection to Public Coverage of Shingles Vaccines
June 21, 2024
- SanBio’s Lead Cell Therapy in Line for Conditional Nod but Can’t Be Shipped Until Comparability Is Confirmed
June 20, 2024
- Xevinapant Earns Sakigake Tag, 6 APIs Get Orphan Status
June 20, 2024
- Opposition Party Urges Health Minister to Scrap Off-Year Drug Price Revision
June 19, 2024
- MHLW to Bankroll Up to 50 Billion Yen Each to KM, Daiichi for Vaccine Trials
June 19, 2024
- Nitrosamine Risk Communication Guidance Issued, Effective Immediately
June 19, 2024
- LDP Tweaks Honebuto Text on Off-Year Revision, Waters Down Push for CEA Expansion
June 18, 2024
- ICH Agrees to Draft Nitrosamine Guideline, Aims to Set Acceptable Intakes
June 18, 2024
- PMDA Chief Strenuously Delivering Info on Japan Regulations at Overseas Confabs
June 17, 2024
- First Generics Joining NHI Price List in June Hits Record Low, Bridion is Only Target
June 14, 2024
- MHLW Proposes Supply Info System for All Prescription Drugs, FY2027 Launch Eyed
June 14, 2024
- SanBio’s Lead Cell Therapy Up for Review Again on June 19
June 14, 2024
- Tezspire Braced for CEA Price Cut, AstraZeneca's Appeal Dismissed
June 13, 2024
- LDP Members Urge Modification of Honebuto Draft to Push Rethink of Off-Year Drug Price Cuts
June 13, 2024
- Social Security Budget Ceiling Looks Set to Continue 3 More Years: Honebuto Draft
June 12, 2024
- Honebuto Draft Equivocal on Off-Year Price Cuts, but Focuses on FY2025 Revision
June 12, 2024
- Label Revisions Ordered for Brimonidine, Finerenone, and More
June 12, 2024
- MHLW to Issue Nitrosamine Risk Communication Guidance by June-End; Draft Now Ready
June 11, 2024
- Govt’s New Capitalism Council Proposes Extending Scope of Mixed-Billing Scheme
June 11, 2024
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