Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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REGULATORY
- PAL Amendment: Proposal Emerges to Submit Legislation by Diet Members for Third Party Organization
April 19, 2012
- Discussions on Use of Cost-Effectiveness Assessments to Begin with Advanced but Costly Technologies: MED Director Suzuki
April 19, 2012
- DPJ Working Team to Hold Hearings on Cost-Effectiveness Assessments, Pricing of Long-Listed Drugs on April 20
April 19, 2012
- Risk Management Plans to Be Required from April 2013 to Strengthen Post-Marketing Safety Measures
April 18, 2012
- PAFSC’s 1st Committee to Discuss Approval for MTPC’s DPP-4 Inhibitor Tenelia at Meeting on April 27
April 17, 2012
- Members of Non-Partisan Study Group Support Generic Drug Use Requirement for Welfare Recipients
April 16, 2012
- CSIMC Expert Subcommittee to Begin Discussion on Long-Listed Drugs in June, Also Deliberate on Targets for Generic Products
April 13, 2012
- CSIMC to Set Up New Subcommittee on Medicoeconomic Assessments
April 13, 2012
- 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
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