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
- PAFSC 1st Committee Recommends Approval for Social Anxiety Disorder for Lexapro
November 4, 2015
- MHLW Weighs Another Business Improvement Order to Novartis
November 4, 2015
- Fiscal System Council Approves MOF’s Proposal for NHI Pricing System Reform
November 2, 2015
- MOF Proposes Full Implementation of Cost-Effective Assessments as Precondition for Full-Scale Introduction of Premium for New Drug Development
November 2, 2015
- Takeda’s Hib Vaccine to Be Reported to PAC in December
November 2, 2015
- PAFSC’s 2nd Committee Receives Report on Add’l Indication for Xeloda, Elplat
November 2, 2015
- MOF Asks Fiscal System Council to Issue Conclusion on Market Price Survey for FY2017 Revision “by Mid-2016 at Latest”
November 2, 2015
- 30% of Generic Companies Unable to Prepare Stable Supply Manuals by End of FY2014; MHLW Official Calls for Early Preparation
October 30, 2015
- Chuikyo Agrees to Tweak “Cost per Course of Treatment” Rule for Combo Drugs after Harvoni Debate
October 29, 2015
- Chuikyo Subcommittee Discusses Envisaged HTA Organization
October 29, 2015
- Chuikyo Sees Big Chorus for Further Reforms in Generic Pricing
October 29, 2015
- Some Chuikyo Subcommittee Members Call for Revision of Rules for Pricing of Biosimilars
October 29, 2015
- Commentary: 1st Sakigake Drugs Picked via “Comparative Evaluation”, Will All Qualified Products Get Designated in the Future?
October 28, 2015
- Thrombopenia Added to Clinically Significant ADR List for Daklinza, Sunvepra
October 28, 2015
- MHLW Eager to Expedite Commercialization of Sakigake Products: New Bureau Head
October 28, 2015
- Keytruda, Novel Anti-Flu Drug Join Japan’s First Sakigake Designation List
October 28, 2015
- MHLW to Talk with MIC about Local Tax Grants to Deal with Increased Costs of Flu Vaccines: Health Service Bureau Chief
October 28, 2015
- 6 Drugs Get Sakigake Designation for Fast-Track Review
October 27, 2015
- New Chief of MHLW Health Policy Bureau Vows to Balance Generic Push and Innovation
October 27, 2015
- ICH Revamped as Legal Entity, PMDA’s Tominaga Picked as Vice Assembly Chair
October 27, 2015
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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…