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
- Pharmacists Will Be Required to Explain Reasons for Not Dispensing Generics in Case of Generic Name Prescriptions from FY2014
March 7, 2014
- MHLW to Set Up Study Group to Discuss Legislation to Regulate Clinical Research “by April at the Latest”
March 6, 2014
- Market Share of Generics Stood at 46.9% Based on New Calculation Method as of September Last Year: MHLW
March 6, 2014
- Januvia/Glactiv to See 10.1% Price Cut Due to Re-Pricing Following Market Expansion
March 6, 2014
- MHLW to Conduct Hearings with Takeda on Blopress Research Data
March 5, 2014
- Pfizer No. 1 Premium Getter in FY2014 Revision, Non-Japanese Makers Sweep Top 10 List
March 5, 2014
- FY2014 NHI Revision Sees Price Cut of 5.64% without Tax Surcharges, 1,118 Long-Listed Products Subject to New Rule
March 5, 2014
- MHLW to Draft Guidelines to Prevent Misuse of Research Funding, Improper Research Activities
March 5, 2014
- Planned Japanese NIH is Research Supporting Agency, Different from Original: Gov't
March 4, 2014
- MHLW Requests University of Tokyo to Investigate SIGN Trial Issues
March 4, 2014
- Drugs Under Ongoing Review for Risk by PMDA Include Mirtazapine for QT Prolongation and Ventricular Tachycardia
March 4, 2014
- PMDA Kansai Branch Poised to Offer More Regulatory Affairs Advice, Inspection Unit to Go Live in April
March 4, 2014
- MHLW Approves 31 APIs for New Ethical Drugs in 2013
March 3, 2014
- PAFSC’s Second Committee Recommends Approval for H5N1 Vaccines
March 3, 2014
- PFSB Issues Safety Information on Thrombosis Associated with YAZ Combination Tablets
March 3, 2014
- MHLW Stresses the Importance of Maintaining Quality of GMP Inspections Following Japan’s Accession to PIC/S
March 3, 2014
- PMDA Begins Disclosing Information on ADRs Reported by Patients through Online Patient ADR Reporting System
February 28, 2014
- Ministry Joint Panel Says Evidence Linking HPV Vaccine Adjuvant with Side Effects Weak
February 27, 2014
- Ethics Code for Epidemiological, Clinical Research to Call for COI Management, Whistle-Blowing: Draft
February 27, 2014
- PFSB Issues Notification on Marketing Authorization Applications for In Vitro Companion Diagnostics
February 27, 2014
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