Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
HOME > REGULATORY
REGULATORY
- CSIMC Approves Listing of Samtirel Without Restriction on Prescription Period
April 12, 2012
- CSIMC Approves 12 APIs/21 Products; Listing Scheduled for April 17
April 12, 2012
- Life Innovation Subcommittee to Recommence Activities, Including 5-Year Strategy: DPJ Project Team
April 12, 2012
- 16 Add’l Prefectures to Participate in Introductory GMP Training Course in Kinki Region
April 11, 2012
- Personnel Exchange Between PMDA, Universities to Facilitate Drafting of GL for Reviewing Innovative Drugs: Deputy Director Miyata of ELD
April 11, 2012
- PMDA to Establish Forum for Discussions Between Reviewers and Outside Researchers to Upgrade Its Ability to Review Cutting-Edge Drugs
April 10, 2012
- MHLW Issues Development Requests for 80 Drugs/Indications with Unmet Medical Needs
April 10, 2012
- MHLW Issues Safety Guidance for First-in-Human Trials
April 10, 2012
- PAFSC to Discuss Approval for Products Including Astellas’s Prostate Cancer Treatment Degarelix
April 9, 2012
- PMDA to Exchange Personnel with Universities, Research Institutes in the Field of Cutting Edge Technologies
April 9, 2012
- MHLW Urges Generic Drug Makers to Ensure Availability of Products for All Indications Approved for Original Drugs
April 6, 2012
- MHLW to Issue 80 Requests for Development of Unapproved Drugs/Indications This Week
April 5, 2012
- Japan to Maintain Drug Pricing System in TPP Talks: Health Minister Komiyama
April 4, 2012
- MHLW Presents Standard Time Frames for Drug Approval Process by Individual Procedure
April 3, 2012
- PMDA Strengthens Consultation System to Support Biomarker Development
April 3, 2012
- MHLW Prepares Q&A to Address Healthcare Professionals’ Concerns About Generic Drugs
April 3, 2012
- DPJ’s PAL Subcommittee to Hold Off Final Recommendation on PAL Amendment Until Late April
April 2, 2012
- MHLW Approves 10 Products Including Pfizer Japan’s Xalkori
April 2, 2012
- CSIMC Recommends Approval of Insurance Coverage for Diagnosis for Xalkori Administration
March 30, 2012
- MHLW Proposes Pricing of Long-Listed Products to Be Concluded in FY2013: CSIMC Meeting
March 30, 2012
ページ
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 FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
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…