PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…
REGULATORY
Amended PMD Law Promulgated, 3-Step Enforcement to Begin Next Year
The Japanese government promulgated the amended Pharmaceuticals and Medical Devices (PMD) Law in the official gazette on December 4, which is slated to be executed in three steps within one, two, and three years. The first implementation eyed for next…
To read the full story
Related Article
- Japan Sets 1st Rollout of Amended PMD Law for Sept. 1
March 9, 2020
- Amended PMD Law Set for 3-Step Enforcement, 1st Execution Eyed Next Autumn
November 28, 2019
- Japan Enacts Amended Pharmaceuticals and Medical Devices Law
November 27, 2019
- Upper House Panel Discusses PMD Law Amendment Bill, Another Session Set for Nov. 26
November 22, 2019
- Lower House OKs PMD Law Amendment Bill
November 15, 2019
- PMD Law Amendment Bill Clears Lower House Health Panel
November 14, 2019
- Substantive Diet Discussions Get Underway for PMD Law Amendment
November 7, 2019
- Discussions on PMD Law Amendment Bill Start in Extraordinary Diet
October 24, 2019
- Health Minister Keen on Passage of PMD Law Amendment in Extra Diet Session
October 8, 2019
- As Curtain Rises on Diet, MHLW Aims to Get Amended PMD Bill Enacted in Early November
October 7, 2019
- MHLW Pharma Bureau Chief Keen on Early Enactment of PMD Amendment Bill
August 5, 2019
REGULATORY
- Japan Eyes Priority Review for MCMs, Bill Submission Planned for 2027
October 28, 2026
- Panel Member Urges Review of Tavneos Blue Letter Timing
October 28, 2026
- Japan Orders Label Revisions for Leqvio, Amenalief, 2 Other Drugs
October 28, 2026
- AbbVie’s Fast-Acting Botulinum Toxin Boey Wins Japan Panel Backing
October 27, 2026
- LDP Lawmakers Renew Push for Routine HPV Shots for Males by April 2027
October 27, 2026
Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
Global drug makers are forging ahead with therapies targeting lipoprotein(a), or Lp(a), a promising new approach to reducing cardiovascular risks.…
Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…