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
- TPP Partners Likely to Accept Japanese Proposal on Data Exclusivity Period: Mr Eto of LDP
September 30, 2013
- Japan Health Minister Meets Exec of Swiss Novartis, Seeks Cooperation in Diovan Probe
September 27, 2013
- Global Simultaneous Development Likely to Expand with Premium for New Drug Development: PhRMA
September 27, 2013
- CSIMC Subcommittee Recommends Addition of Consumption Tax to Actual Market Prices, Will Continue Discussing Method for Clearly Specifying Added Tax
September 27, 2013
- JPWA Seeks Generic Name Listing for Wider Range of Generics
September 27, 2013
- FPMAJ Opposes Removing Exceptions for 80% Pricing Rule for Racemic Body-Derived Drugs
September 26, 2013
- Mixed Healthcare Using Unapproved Drugs Proposed for Special Zone
September 26, 2013
- Health Ministry Approves 28 Products including Oblean, Kadcyla
September 26, 2013
- Discussions on Reform of the High-cost Healthcare Benefit System on the Horizon; Will It Be Possible to Reduce Drug Copayments?
September 25, 2013
- Japan Needs Generic Drug Makers that Can Compete in the Global Market: Director Jo of EAD
September 25, 2013
- Regulatory Reform Council Sets Out Policies to Monitor Ministries’ Deregulation Efforts
September 24, 2013
- MHLW to Introduce E2B (R3) Format in April 2016
September 24, 2013
- FTC’s Legal Intervention in Diovan Issue Possible, but Only with New Facts: Lawyer
September 20, 2013
- MHLW Requests Revision of Package Inserts for Losartan, Celecoxib, 9 Other Drugs
September 19, 2013
- MHLW Plans to Establish Ethics Committee Certification System to Improve the Quality of Clinical Research
September 18, 2013
- Diovan Scandal Undermined National Interests, Health Ministry Official Says
September 18, 2013
- Director Jo of EAD Urges Drug Makers to Go on the Offensive
September 18, 2013
- PAFSC Second Committee Supports Hepatitis C Treatment Simeprevir, Plasma Fraction Product Hizentra
September 17, 2013
- Intussusception to Be Added to Adverse Reaction Section of Package Insert of RotaTeq
September 17, 2013
- Regulatory Reform Council Puts Off Concluding Discussion on Use of Clinical Intervention Study Data for Drug Applications
September 13, 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…