Japan’s ruling coalition sustained a crushing blow in the Lower House election last month, only managing to win 215 seats,…
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REGULATORY
- First Generics of Livalo, Glivec Added to NHI Price List: MHLW
December 13, 2013
- No Diovan, Livalo AGs for December Generic NHI Listing
December 13, 2013
- PFSB Begins Discussions Toward Lifting Ban on Subcontracting of Safety Management Tasks
December 12, 2013
- MHLW Notifies Authorities of Expiration Date Extension for Relenza from 7 to 10 Years
December 12, 2013
- 3-Drug Therapy Including Simeprevir for Chronic Hepatitis C to Be Eligible for Medical Expense Assistance: MHLW
December 11, 2013
- September Price Settlement Rate at 73.5%; Low Figure Blamed on Pharmacy Chains
December 10, 2013
- Japan Diet Enacts Bill to Open Door for Online OTC Drug Sales
December 10, 2013
- FPMAJ OKs Concession Plan on Key Premium; Bill Payers Stick to Opposition
December 9, 2013
- Average Drug Price Discrepancy Rate at 8.2%: Health Ministry
December 9, 2013
- PMDA Aims to Solidify Partnerships with Overseas Regulators via February Symposium
December 9, 2013
- MHLW to Make Additional Appeal for Applicants for Special Grants to Produce Vaccines for New Strains of Influenza
December 6, 2013
- MHLW Calls for Caution on ADRs Associated with Axitinib, Bevacizumab
December 6, 2013
- Revision of Notification on Advanced Healthcare Introduces New Rules for Anticancer Drugs
December 5, 2013
- Would Proposed New Rule for Repricing Long-Listed Drugs Create Winners and Losers? Bill Payers Opposed, Industry Watching Closely
December 5, 2013
- PAFSC’s First Committee Backs Japan’s 1st SGLT-2 Inhibitor
December 2, 2013
- 11 APIs/33 Products Including ComPlavin Added to NHI Price List
December 2, 2013
- PFSB Issues Notification Calling for Revisions of Package Inserts for Drugs Including Aricept, Cravit
December 2, 2013
- Toned-Down Proposal on “Precursor” Premium Still Leaves CSIMC Wary; 10% Tabled with Strings Attached
November 29, 2013
- New Proposals by Regulatory Reform Council Include Elimination of 14-Day Prescription Limit
November 29, 2013
- New Combination Drugs Containing Non-Innovative APIs Should Be Priced Based on Prices of Other APIs Contained: CSIMC Subcommittee
November 29, 2013
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For over two decades, Morunda has been at the forefront of interviewing and understanding leaders within Japan’s dynamic healthcare industry, particularly in pharmaceuticals and medical devices. What sets apart successful country managers in this competitive arena isn’t just their professional…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
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…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…
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…