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
- New Basic Guidelines for Hepatitis Measures to Push IFN-Free Therapies, Hep B Vaccines
March 18, 2016
- MHLW Official Asks Industry to Discuss Candidates for Essential Medicines
March 18, 2016
- Kamoya Prods Regulatory Science Society to Compile Essential Drug List
March 17, 2016
- Whether to Draw Line between 15 Billion and 100 Billion Yen Sales Thresholds for Re-Pricing Will Hold Key: Kamoya, Nakai
March 17, 2016
- Coefficient for New Generic Pricing “Will Decline Further” if Business Practices Are Not Changed: JGA Official
March 17, 2016
- Opdivo Gets Orphan Status for Hodgkin’s Lymphoma
March 17, 2016
- Nobelpharma CEO Says Sakigake System “Very Helpful”
March 17, 2016
- PMDA Had 43 Advanced Regulatory Advisory Sessions with Startups, Academia in FY2015
March 16, 2016
- Vaccine Panel Wary about Including Synflorix in Public Immunization Program
March 16, 2016
- Oculomucocutaneous Syndrome, Erythema Multiforme Added to ADR List for Halaven
March 16, 2016
- MHLW to Require CTD-Based Submissions for Generics, Effective March 2017
March 15, 2016
- Sales Thresholds for Re-Pricing Rule to Be Key Point of Future Discussions: MHLW Pharma Management Director
March 15, 2016
- MHLW Panel Launches Discussions on New Basic Plan against Cancer
March 14, 2016
- MHLW Panel Roughly OKs Use of MID-NET Database by Drug Makers
March 14, 2016
- No Licensing Deal Clinched for First AMED-Backed Drug Seed
March 14, 2016
- MHLW’s Info Gathering System for Pediatric Drugs Goes Live
March 14, 2016
- Japan to Lead Initiatives to Disseminate Regulatory Submission, Review Rules in APEC
March 14, 2016
- MHLW Wants to Continue Price Maintenance Scheme for On-Patent Drugs: Shiozaki
March 11, 2016
- Shiozaki Seeks Understanding for “Huge-Seller” Drug Re-Pricing
March 11, 2016
- Drug Makers Should Have Freewheeling Discussions towards 2018 Reform, MHLW Wants to Pick Their Brains: Official
March 10, 2016
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