Discussions by the Ministry of Health, Labor and Welfare’s (MHLW) study group on the generic industry structure are reaching the last lap. Its final report - a draft of which will be presented later this month - is expected to…
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REGULATORY
- 3 Ex-Officials of MHLW, NHO Affiliated with Novartis in 2010, Govt Says
August 15, 2013
- PMDA Meets All Targets for FY2012 with Exception of Time Spent by Applicants for Non-Priority Products
August 15, 2013
- Can Japan Become the Global Leader in Drug Discovery? New Vision for Pharmaceutical Industry Drops Company Categories Included in the Previous One
August 15, 2013
- PAFSC 2nd Committee to Review GSK’s Combination Asthma Drug on Aug. 26
August 14, 2013
- MHLW Compiles Report on Expert Council on Future Cancer Research
August 14, 2013
- EAD Director Visits 5 Hospital HQ to Urge Early Price Settlements, Greeted with Mixed Enthusiasm
August 13, 2013
- 41,254 ADR Reports Received from Marketing Authorization Holders in FY2012: MHLW
August 13, 2013
- Japan NIH HQ to Orchestrate Allocation of 100 Billion Yen for R&D Budgets, Starting with FY2014 Requests
August 12, 2013
- 1st Committee on Drugs to Discuss Pediatric Indication for Kyowa Kirin’s Nesp
August 12, 2013
- MHLW Diovan Committee: 3 More Universities Give 1st Probe Updates, SMART Data Rapped “Sloppy”
August 12, 2013
- MHLW Taps 12 Experts to Serve on Diovan Study Committee; J-CLEAR’s Kuwajima, JAMS’s Sone on the List
August 9, 2013
- PMDA to Make Public Adverse Reactions Reported by Patients by Year-End
August 8, 2013
- US FDA Advisory Committee Votes Against Approval of Tolvaptan for Treatment of ADPKD
August 8, 2013
- Education Ministry Set Up Task Force for Prevention of Misconduct in Research, Will Discuss Diovan Issue
August 7, 2013
- Gov’t to Establish “Headquarters to Promote Health and Healthcare Strategy” as HQ for Japanese Version of NIH
August 6, 2013
- First Committee on Drugs Recommends Approval for Long-Acting Injectable Schizophrenia Treatment Xeplion
August 6, 2013
- Health Ministry’s Diovan Study Committee to Start on Aug 9, Minister Expects Attendance of Ex-Novartis Employee
August 5, 2013
- EAD Director to Personally Visit Hospitals to Urge Early Price Agreement
August 5, 2013
- Distribution Reform and Perpetuation of Premium for New Drug Development Are Immediate Top-Priority Issues: EAD Director Jo
August 2, 2013
- CSIMC Subcommittee Discusses Revisions of Drug Pricing Rules; Some Reps Oppose Proposed Rewards for Innovation
August 1, 2013
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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…