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
- Administrative Penalty on Nichi-Iko Possible by March-End over Recalls
January 15, 2021
- Special Mitigation Margin for COVID-19 Up for Debate towards FY2022 Drug Price Revision: MHLW Bureau Chief
January 15, 2021
- MHLW Initiates Discussions on Amendment of Clinical Research Law
January 15, 2021
- Thaled Up for PAFSC Review for POEMS Syndrome on Jan. 27
January 15, 2021
- Chuikyo to Discuss Health Coverage for Fertility Treatments from This Summer
January 14, 2021
- Chuikyo OKs Revised NHI Pricing Rules for FY2021 Drug Re-Pricing
January 14, 2021
- MHLW to Run Fresh Survey on Drug Makers’ Responses to Promotion Guidelines
January 13, 2021
- PMDA Updates Veklury Label to Allow Its Use in Moderate COVID-19
January 8, 2021
- MHLW Compiles New Clinical Assessment Guidelines on Neuropathic Pain Drugs
January 7, 2021
- MHLW Informs of New Guideline on Exemption from Bioequivalence Studies for Oral Drugs
January 7, 2021
- Govt Eager to Roll Out 1st COVID-19 Vaccine by Late February; PM Says Pfizer’s Japan Data Ready by Month-End
January 5, 2021
- AMED to Fund 14 Projects under CiCLE Program
January 5, 2021
- 3 API Manufacturing Repatriation Projects by Meiji, Nipro, Shionogi Adopted for MHLW Funding
January 5, 2021
- MHLW Approves Label Expansions for Olumiant, Gardasil, Lynparza and More
December 28, 2020
- MHLW Grants Orphan Status to 5 APIs
December 28, 2020
- Japan’s Drug Production Swells 37.3% to 9.5 Trillion Yen in 2019: MHLW Survey
December 28, 2020
- MHLW Drafts Guidelines for Use of Patient Registry Data in Regulatory Filing
December 25, 2020
- Japan Prepping to Expand Veklury Label beyond Severe COVID-19: PMDA
December 25, 2020
- Coronavirus Panel Draws Up Plan for Vaccination System, Priority
December 25, 2020
- Results of On-Site Probe into Kobayashi Kako Due Out Early Next Year, MHLW Eyes Biz Suspension
December 24, 2020
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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…