Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
In a Flip-Flop, LDP Aims to Enact Clinical Research Bill in Current Diet Session
The ruling Liberal Democratic Party (LDP) has reversed its course, and now says it aims to enact a bill on the legal regulation of clinical research during the current ordinary session of the Diet, which will run through June 1.…
To read the full story
Related Article
- Clinical Research Law Promulgated
April 17, 2017
- Clinical Research Bill Passed into Law
April 7, 2017
- Clinical Research Bill Passes Lower House
March 23, 2017
- Clinical Research Bill Clears Lower House Health Panel
March 21, 2017
- Clinical Research Bill Set to Sail through Extra Diet with Opposition Backing
September 27, 2016
- Clinical Research Bill Didn’t Clear Diet, Now under Continued Review
June 2, 2016
- Clinical Research Bill Unlikely to Clear Diet in Current Session
May 27, 2016
- Clinical Research Bill to Enter Diet Deliberations on May 20, Might Be Enacted June 1
May 19, 2016
- Clinical Research Bill OK’ed by Cabinet, Now Up for Diet Deliberations
May 13, 2016
- Clinical Research Bill Won’t Be Enacted in Current Diet Session: LDP Health Panel Chief
March 30, 2016
- Difficult to Enact Clinical Research Bill in Current Diet Session: LDP Health Panel Chief
March 9, 2016
- Diet Submission of Clinical Research Bill Expected for Next Year: Panel Member
December 15, 2015
- MHLW Mulls Legal Disclosure of Drug Makers’ Clinical Research Payments
May 13, 2015
- LDP Legislators Discuss Legal Regulation of Clinical Research
April 1, 2015
- Will Legal Regulation Propel or Stymie Clinical Research? “Risk-Based” Approach Holds Key
January 13, 2015
REGULATORY
- MHLW Issues Q&A on Conditional Approval System
May 1, 2026
- Panel Backs Proposal to Allow Antibody Drugs Like Beyfortus in NIP
May 1, 2026
- METI Clarifies Naphtha Comments, Reaffirms Medical Priority
April 30, 2026
- Japan Minister Rules Out Full Self-Pay for OTC-Like Drugs
April 30, 2026
- Govt’s Bio-WG Wraps Up Biopharma Investment Roadmap Draft
April 30, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…