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
- New Pharma Industry Vision to Set Out Roles of Wholesalers: MHLW Director
July 16, 2021
- Snap Inspections at Generic Plants Conducted in 46 Prefectures, Results Due Out in August
July 16, 2021
- Japan to Lower Moderna Vaccine’s Minimum Age to 12
July 16, 2021
- MHLW Unmet Needs Council OKs Public Knowledge-Based Filings for 2 Antiemetics
July 15, 2021
- ICMRA Discussing Substitutes for Placebo-Controlled Trials of COVID Vaccines: MHLW
July 15, 2021
- Forxiga’s CKD Indication Up for PAFSC Review on July 28, Possible OK in August
July 15, 2021
- Chugai’s Antibody Cocktail Up for PAFSC Review on July 19, 4th COVID-19 Drug If Approved
July 13, 2021
- No Major Safety Concerns for Moderna, Pfizer COVID-19 Vaccines: MHLW
July 9, 2021
- Japan PM “Watching Expert Discussions” on AstraZeneca Vaccine Use
July 9, 2021
- Japan OKs FY2022 Budget Guidelines, 660 Billion Yen Cap for Social Security Cost Rise
July 8, 2021
- MHLW Announces 1st Revision of Dyslipidemia Drug Development Guidelines in 30 Years
July 8, 2021
- Label Revisions Ordered for Myocarditis/Pericarditis Risks of Pfizer, Moderna’s COVID Vaccines
July 8, 2021
- MHLW’s COVID-19 Guide Recommends against Camostat after Trial Failures
July 7, 2021
- Health Minister Hints at Priority Vaccine Supply to Municipalities Making Headway
July 7, 2021
- MHLW Ups Ante for Regulatory Reviews of Jointly Developed Generics
July 7, 2021
- Leigh Syndrome Drug PTC743 Gets Orphan Status
July 6, 2021
- Draft Revision of MHLW’s Distribution Guidelines Stresses Compliance with Antitrust Act
July 5, 2021
- Govt to Provide Vaccines for All Workplace Programs Requested
July 5, 2021
- MHLW Urges Wholesalers to Strictly Enforce Legal Compliance after Bid-Rigging Ruling
July 2, 2021
- Sakigake Tag Revoked for Eisai’s E7090 after Pemazyre Approval
July 1, 2021
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Chugai Pharmaceutical’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys has finally reached the Japanese market after months of safety reviews…
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…