Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Biosimilar Efficacy Trials Can Be Waived under Certain Conditions: MHLW
Japan’s health ministry has clarified that comparative clinical efficacy trials for biosimilars can be omitted if sufficient data demonstrate biosimilarity to the reference biologic through pharmacokinetic (PK) or pharmacodynamic (PD) studies. The Ministry of Health, Labor and Welfare (MHLW) clarified…
To read the full story
Related Article
- PMDA Urges Quality-Driven Biosimilar Development as CES Waivers Take Hold
August 18, 2026
- CES Waivers Could Slow Biosimilar Uptake without Better Communication: Industry
July 23, 2026
- ICH Weighs Need for Biosimilar Efficacy Trials as Regulators Move Away from Routine Use
March 9, 2026
- English Versions of MHLW Biosimilar Trial Guidance, Q&As Now Available
March 13, 2024
- MHLW No Longer Requires Japanese Comparability Data for Certain Biosimilars: Q&A Update
January 26, 2024
- Biosimilar Guidelines Nearing 1st Revision in 10 Years, MHLW Taking Public Comments
July 2, 2019
REGULATORY
- 679 Safety Reports Logged for Regenerative Medical Products in 2H FY2025
August 21, 2026
- Japan Panel to Discuss Approval of 6 NMEs, Leqembi SC on Aug. 26
August 20, 2026
- DPP Lawmaker Calls for Inflation Relief in 2027 Off-Year Drug Price Revision
August 19, 2026
- CEA Review Group Wraps Up Technical Debate, Urges More Company Access
August 19, 2026
- Japan Panel to Weigh Keytruda SC, J&J Psoriasis Pill among 6 NMEs on Aug. 24
August 18, 2026
Japan’s pharmaceutical policy appears to be entering a new phase. The government’s newly approved honebuto policy and growth strategy both…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
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…