Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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REGULATORY
- 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
- CSIMC to Discuss Introduction of Medicoeconomic Assessment in FY2014
March 30, 2012
- MHLW Issues Safety Warning on Use of Afinitor in HBV Carriers
March 30, 2012
- Office of Medical Innovation Begins Discussions on “Five-year Strategy for Medical Innovation”, Compiles Interim Report by Mid-April
March 29, 2012
- “MHLW Ideal” Placement for Drug Discovery Support Organization: Medical Innovation Office Counselor Hachiyama
March 28, 2012
- Handling of Adverse Reaction Data an Issue in Access System Adaptation: MHLW Deputy Director Miyata
March 28, 2012
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