The Ministry of Health, Labor and Welfare (MHLW) on September 19 proposed restructuring the Japanese generic industry by restricting the…
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REGULATORY
- CSIMC General Assembly Establishes Premium for Prescriptions by Generic Name
January 31, 2012
- PAFSC’s First Committee Recommends Designation of Pasireotide Pamoate as Orphan Drug
January 30, 2012
- JPO Decides Lipitor Crystal Form “Valid”, Sandoz Calls for Appeal
January 30, 2012
- PAFSC’s First Committee Recommends Approval for Zyprexa for Depression in Bipolar Disorders
January 30, 2012
- MHLW Grants Fast Track Review Status for Applications for Generic Brand Name Change
January 27, 2012
- MHLW Presents New 5-Year Plan to Promote Clinical Trials
January 27, 2012
- CSIMC Recommend Approval for Basic Proposal for FY2012 NHI Pricing; 0.86% Price Cut for Long-Listed Drugs, 0.33% for Generics
January 26, 2012
- NHI Price Reduction Method Changed for Aricept, Flolan
January 26, 2012
- Rule Review in Similar Drug Re-Pricing Yields 50 Exemptions Based on Competitiveness
January 26, 2012
- Correct Dosage, Administration for Lamictal Asked: Pharmaceuticals Safety Info
January 26, 2012
- Companies Should Be Required to File Notifications for Package Inserts: Subcommittee
January 26, 2012
- HSC Subcommittee Approves Revised Ethical GL for Genomics Research
January 26, 2012
- PMDA Considering Review Procedure Policy for IVD Agents Based on FDA Guidance Draft
January 25, 2012
- 16 APIs Including Aricept, Lyrica to Be Re-Priced for Market Expansion
January 25, 2012
- MHLW to Issue Revised Notifications in Preparation for Application to PIC/S
January 25, 2012
- Revised Basic Plan Against Cancer to Include Pediatric Cancer Measures
January 24, 2012
- Senior Vice Minister Tsuji to Actively Support Creation of 3rd-Party Organization
January 23, 2012
- Proposed Amendment of PAL Would Require Submission of Package Inserts: Mr Kikura
January 23, 2012
- Huge Drop in Compliance Rate for “Explanations in Writing” in Sales of Class 1 OTC Drugs: MHLW Undercover Survey
January 20, 2012
- PMDA to Introduce Direct ADR Reporting System for Patients on Trial Basis
January 20, 2012
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As Japan moves into elaborate discussions on the potential reform of its cost-effectiveness assessment (CEA) in FY2024, members of a…
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The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…