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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- PMDA to Discuss Optimal Use of Xofluza amid Concerns over Resistant Viruses
June 17, 2019
- 10 More Hospitals to Join MID-NET Database, Covering Data on 6 Million Patients
June 17, 2019
- PMDA Reviewing Risks for Ibrance, Opdivo, Keytruda and More
June 17, 2019
- LDP’s Pharma Study Group Submits Proposal to Health Minister, Calls for PMP Revamp in 2020 Reform
June 13, 2019
- Nesp Biosame to Join NHI Price List, Launch Due by September; Symbicort Generics, Teribone AG Skip Listing
June 13, 2019
- Govt’s Draft Policy Blueprint Prods Continued Debates on Pricing Reform Proposals; Expanded HTA Use, Handling of PMP-Granted Comparators and More
June 12, 2019
- PMDA Chief Mulls Requiring Few-Year Clinical Background for Reviewers
June 12, 2019
- PMDA to Form Panel on Relief System to Ensure Access, Quick Remedy
June 11, 2019
- MHLW Study Group Drafting Guidelines for New Dyslipidemia Drug Development, First in 30 Years
June 11, 2019
- Deregulation Panel Proposes Giving Private Companies Access to National Health Database to Promote New Drug Development
June 10, 2019
- MHLW Vaccine Panel Discusses Inclusion of Rotavirus Vaccine in Public Vaccination Programs; Has “Enough Data”
June 7, 2019
- Shock, Anaphylaxis Added to Xofluza’s ADR List; Label Changes for Checkpoint Blockers
June 5, 2019
- MHLW Panel Approves to Contraindicate Metformin in Impaired Kidney Function Patients with eGFR less than 30
June 4, 2019
- Reborn PMDA Boots Up under New Skipper, Bolstering “Patient First” Initiatives
June 4, 2019
- Kampo Industry Expresses Concerns over Copay Hikes, Narrow Definition of Essential Drugs: LDP League
June 3, 2019
- Bayer’s Larotrectinib, Novartis’ Capmatinib Get Orphan Status in Japan
June 3, 2019
- June Approval Likely for Chugai’s NTRK-Gene Targeting Entrectinib, 2nd Tumor-Agnostic Drug
May 31, 2019
- LDP Junior Politicians Set Up Vaccine Study Group
May 31, 2019
- “Drugs for Specific Use” Might Include NTD Medicines: MHLW Official
May 30, 2019
- Chuikyo Subcommittee Agrees on Discussion Timeline, Topics for 2020 Drug Pricing Reform
May 30, 2019
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International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…