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
- Panel Backs Approval of Add’l Indication for J-TEC’s Cell Sheet JACE
September 21, 2016
- Combo Use of 2 Different Hep B Vaccines Produced Necessary Antibody Titer, No Serious ADRs: Report
September 21, 2016
- AMED Official Outlines Pre-Orphan Designation Support Scheme
September 20, 2016
- 3 Major Regulators Will Cooperate on Common Guidelines for Development of Antibacterial Drugs: PMDA Official
September 20, 2016
- As Personal Info Law Amendment Looms, Govt Official Tells Drug Makers to Review Info in Hand
September 16, 2016
- International Meeting of World Pharmacopoeias OKs GPhP Draft
September 16, 2016
- In-Kind Research Support Would Be Effective in Commercializing Drug Seeds: Paper
September 15, 2016
- FY2015 Japan Drug Spending Up 11% on Hep C Meds
September 15, 2016
- Industry Chiefs, Chuikyo Panelists Trade Barbs over Market Expansion on Add’l Indications
September 15, 2016
- 3 Pharma Groups Firmly Oppose Out-of-Cycle Re-Pricing at Chuikyo
September 15, 2016
- G-CSF Preparations Ordered to Add Anaphylaxis in ADR List
September 14, 2016
- Blue Book “Will Be Used as Reference When Selecting Generics”: Panel Chair
September 14, 2016
- PMDA, FDA, EMA Agree on 6 Regulatory Approaches on AMR
September 13, 2016
- G7 Health Ministers Adopt Kobe Communique
September 13, 2016
- Generics from 5 Companies Enough When Major Products Lose Patent Protection: Top Bureaucrat
September 13, 2016
- Kaketsuken “Should Seriously Reflect” on Its Conduct before Asking for Permission to Continue Business: Health Minister
September 12, 2016
- MHLW Panel Backs Approval of Pembrolizumab, Some Voice Concerns for Its High NHI Price
September 12, 2016
- MHLW Panel OKs Humira for Uveitis
September 12, 2016
- Kaketsuken’s Business Transfer Necessary: MHLW Official
September 9, 2016
- MHLW Reports Partial Modifications of Approval for 3 Drugs Including Polidocasklerol to Advisory Panel
September 9, 2016
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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…