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REGULATORY
- Updated Rules OK’ed for FY2024 Reform, 5-10% Rate Set for New Premium to Counter Lag/Loss
January 18, 2024
- 9 APIs to Earn Increased Premiums in FY2024 Price Revision; Jakavi Gets Multiple Premiums
January 18, 2024
- MHLW Publishes Report on Drug Marketing System towards PMD Law Amendment
January 17, 2024
- MHLW Issues Notification to Clarify Orphan Designation Criteria
January 17, 2024
- FY2024 Reform Will Bolster Rewards for Innovation to Eradicate Drug Lag/Loss: LDP Policy Bigwig
January 16, 2024
- Legal Changes Needed to Push Use of Pseudonymized Data in Drug R&D: MHLW Working Group
January 16, 2024
- MHLW’s Planned Bill Would Exclude Certain Programs from “Specified Clinical Trials”
January 16, 2024
- MHLW Plans to Submit 4 Bills to This Year’s Ordinary Diet Session
January 16, 2024
- New LLP Coverage Rule Aimed to Transform Industry Rather Than Eke Out Savings: LDP Social Security Chief
January 15, 2024
- MHLW Issues Notification on Pediatric Development Plans
January 15, 2024
- Pharma Regulation Panel to Explore Potential Criteria for All-Case PMS Requirement
January 15, 2024
- Nobelpharma’s Hypozincemia Med, Jardiance’s CKD Use Up for PAFSC Review
January 15, 2024
- Japan Designates Noto Peninsula Quake as Severe Disaster
January 12, 2024
- MHLW Study Underway on Lab Monkey Shortage, Research Team Frets Dependence on Specific Sources
January 11, 2024
- MHLW Orders Label Revisions for Keytruda, Tecentriq, and More
January 11, 2024
- Handling of Big-Seller Candidates Is Top Priority as Japan Seeks Good Budget Balance: Minister
January 10, 2024
- Drugs Being Delivered to Quake-Hit Areas Day after Request: Minister
January 10, 2024
- Panels Urge OTC Switches “within 3 Years” for Drugs Sold Over the Counter in 2 or More Other Countries
January 5, 2024
- MHLW Unveils Draft Guidelines on Access to Intractable, Pediatric Disease Databases
January 5, 2024
- FY2024 Reform Heralds Shift to Funding Cycle within Drug Budget: MHLW Pharma Director
December 28, 2023
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Earlier this month, Health Minister Keizo Takemi called on the top executives of 13 major generic makers to restructure the industry with a product consolidation target of “around five companies per API.” While a variety of restructuring options are conceivable,…
The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
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…