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
- Foreign Price Adjustment Doesn’t Make Much Sense for Drugs with Similar Meds in Japan: Industry
February 23, 2017
- Overhaul Rules to Pick Comparator Meds in Similar Drug Pricing Method: Chuikyo Rep
February 23, 2017
- Council Drafts Scheme to Provide Unapproved Drugs in Response to Infectious Disease Outbreaks in Developing Countries
February 23, 2017
- Use of Generic Drugs Increases, Lingering Concerns Over Quality: Survey
February 23, 2017
- CEFP Working Group to Go Full Throttle on Policy Guidelines Debate in March
February 22, 2017
- New Formats for Package Inserts to Be Announced in April, Enforced from FY2019 with Transition Period: MHLW
February 21, 2017
- MHLW to Strike Balance between Pricing Reform and Generic Promotion: Official
February 20, 2017
- MHLW Advisory Committee to Discuss Ninlaro on March 3
February 20, 2017
- MHLW Advisory Panel to Review Shionogi’s ADHD Drug on March 2
February 17, 2017
- MHLW Ups Ante on Drug Distribution after Fake Harvoni Issue
February 17, 2017
- Council OKs Public Knowledge-Based Applications for Rituxan, Ovisot
February 17, 2017
- MHLW Council Recognizes High Medical Need for 4 APIs/5 Products Including Extended-Release Levodopa/Carbidopa Combo
February 17, 2017
- MHLW Council Discusses Issue of Development Requests for Drugs with Low NHI Prices, Few Patients
February 17, 2017
- With Eye to June Listing, 24 Generic Makers Flock to Micardis Family, 15 to Abilify
February 16, 2017
- Optimal Use Guidelines Issued for Opdivo, Keytruda for Melanoma, NSCLC Use
February 15, 2017
- Label Changes Ordered for Atarax, Zelboraf on New ADRs
February 15, 2017
- MHLW Mulls Administrative Penalties, Tighter Regulations after Counterfeit Harvoni Case
February 14, 2017
- Ex-LDP Health Panel Chief Calls for Changing Copay Rates for Different Drugs
February 13, 2017
- Zoster Vaccine’s Add’l Use, DPT Vaccine’s Booster Dose Put Under Continued Discussion for Public Immunization Program
February 13, 2017
- PMDA Eyes 15-20% New Drug Review Fee Raise in April, Plan Now Up for Public Comments
February 13, 2017
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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…