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
- MHLW Official Positive about Seeking Budgets to Boost PMDA Reviewers
July 29, 2016
- Pricy Meds Issue Takes a Step Forward with 2-Faceted Proposal
July 29, 2016
- Chuikyo OKs Plan to Compile “Optimal Use Guidelines,” Beginning with Opdivo, Repatha
July 28, 2016
- Chuikyo to Discuss Out-of-Cycle Re-Pricing for Opdivo, but JMA Turns Wary
July 28, 2016
- MHLW to Work with PMDA from an Early Stage to Build Clinical Innovation Network: Division Head
July 28, 2016
- MHLW to Canvass Drug Makers’ Opinions on Real-World Roles of “3 Key Officers”: Pharma Safety Head
July 27, 2016
- Expert Taskforce Roughly OKs Report on Genomic Medicine
July 26, 2016
- ICH Clinical Trial Guidelines Allow Flexibility on Number of Japanese Subjects Needed: PMDA Official
July 26, 2016
- Revised GCP Ordinances Open Ways for Compassionate Use of Medical Devices, Regenerative Medicines
July 25, 2016
- MHLW Panel to Review ASKA’s Hepatic Encephalopathy Drug, Opdivo’s RCC Indication on Aug. 5
July 25, 2016
- Intractable Neurological, Psychiatric Diseases Initially Eyed for PMDA-NCNP Drug Development Guidelines
July 25, 2016
- MHLW Alerts on Use of EGFR TKIs in Opdivo-Treated Patients after 3 Deaths
July 25, 2016
- MRSA Infections Add 190 Billion Yen Annually to Medical Expenditure at DPC Hospitals: MHLW Study Group
July 25, 2016
- MHLW Advisory Panel to Discuss Novartis’s Acromegaly Drug on August 4
July 22, 2016
- MHLW Panel OKs Basic Policies for Next JP Edition, Due Out 2021
July 21, 2016
- ICH Guidelines on Multi-Regional Clinical Trials Up for Public Comments: MHLW
July 21, 2016
- Ono Issues Red Flag over Use of Immunotherapies Together with Opdivo
July 21, 2016
- PMDA to Announce Evaluation Policy on Diagnosis Using Next-Generation Sequencers
July 21, 2016
- PMDA Working Group to “Feed Back Experiences in Reviews” toward Creation of Clinical Innovation Network
July 20, 2016
- 14-Day Prescription Limit Won’t Be Eased: MHLW
July 19, 2016
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