Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Emergency Approval Plan Clears Lower House Panel; Opposition Bills Rejected, but Some Ideas Make It into Resolution
A draft bill to amend the Pharmaceuticals and Medical Devices (PMD) Law, which embraces the introduction of an emergency approval scheme, sailed through the Lower House’s health committee on April 15. Three opposition bills were voted down, but some elements…
To read the full story
Related Article
- Japan’s Emergency Approval System Comes into Force, Nod Based on Presumed Efficacy
May 23, 2022
- Japan Clears Bill to Create Emergency Approval System, Enforcement Slated by Month-End
May 13, 2022
- Products Filed for Conditional OK Can Be Switched to Emergency Approval: MHLW Official
April 27, 2022
- Upper House Starts Deliberations on PMD Law Amendment Bill
April 25, 2022
- Japan’s Lower House OKs PMD Law Amendment Bill
April 20, 2022
- Shionogi COVID Pill Doesn’t Meet “Presumed Efficacy” Criteria: HSC Subcommittee Chair
April 13, 2022
- Extension of Emergency Approval Period Would Be Allowed Only Once: MHLW Official
April 7, 2022
- Japan PM Touts Proposed Emergency Approval Scheme as Bill Enters Diet Deliberations
April 1, 2022
- PMD Law Amendment Bill to Enter Diet Debate March 31, CDP’s Counter-Legislation Too
March 30, 2022
- Opposition Party Mulls Counter-Legislation against PMD Law Amendment Bill
March 24, 2022
- Japan Cabinet OKs Draft Bill to Amend PMD Law
March 2, 2022
- Bill to Amend PMD Law Set for Cabinet Approval as Early as March 1
February 24, 2022
- LDP Health Committee OKs Bill to Amend PMD Law
February 18, 2022
- LDP Health Committee to Review PMD Law Amendment Bill Mid-February
February 10, 2022
REGULATORY
- Japan Panel to Weigh Keytruda SC, J&J Psoriasis Pill among 6 NMEs on Aug. 24
August 18, 2026
- PMDA Urges Quality-Driven Biosimilar Development as CES Waivers Take Hold
August 18, 2026
- Japan Calls for APOE Testing before Leqembi, Kisunla Treatment
August 18, 2026
- Label Revised for DMD Drug Viltepso Based on PIII Miss
August 18, 2026
- Trazenta Draws 8 Generic Entrants as Japan Clears New DPP-4 Copies
August 17, 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…