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
- MHLW to Draft Guidelines to Prevent Misuse of Research Funding, Improper Research Activities
March 5, 2014
- Planned Japanese NIH is Research Supporting Agency, Different from Original: Gov't
March 4, 2014
- MHLW Requests University of Tokyo to Investigate SIGN Trial Issues
March 4, 2014
- Drugs Under Ongoing Review for Risk by PMDA Include Mirtazapine for QT Prolongation and Ventricular Tachycardia
March 4, 2014
- PMDA Kansai Branch Poised to Offer More Regulatory Affairs Advice, Inspection Unit to Go Live in April
March 4, 2014
- MHLW Approves 31 APIs for New Ethical Drugs in 2013
March 3, 2014
- PAFSC’s Second Committee Recommends Approval for H5N1 Vaccines
March 3, 2014
- PFSB Issues Safety Information on Thrombosis Associated with YAZ Combination Tablets
March 3, 2014
- MHLW Stresses the Importance of Maintaining Quality of GMP Inspections Following Japan’s Accession to PIC/S
March 3, 2014
- PMDA Begins Disclosing Information on ADRs Reported by Patients through Online Patient ADR Reporting System
February 28, 2014
- Ministry Joint Panel Says Evidence Linking HPV Vaccine Adjuvant with Side Effects Weak
February 27, 2014
- Ethics Code for Epidemiological, Clinical Research to Call for COI Management, Whistle-Blowing: Draft
February 27, 2014
- PFSB Issues Notification on Marketing Authorization Applications for In Vitro Companion Diagnostics
February 27, 2014
- US FDA, EMA Hold Monthly Regulatory Working-Level Talks, with Participation of PMDA as Observer
February 27, 2014
- EMA Recommends Approval for Fixed-Dose Combination of Canagliflozin, Metformin
February 27, 2014
- Cabinet OKs Bill to Merge NIBIO, NIHN to Create New Institute
February 26, 2014
- PAFSC’s First Committee Supports Approval of Novel Antiplatelet Agent Prasugrel
February 25, 2014
- Penalty for Lengthy Drug Delivery Talks Will Lift Price Settlement Rates: Minister
February 25, 2014
- MHLW May Take Harsh Action against Novartis over Diovan Raids: Minister Tamura
February 25, 2014
- LDP Closes Discussions on Fee Cuts to Be Imposed on Hospitals, Pharmacies with Low Price Settlement Rates
February 25, 2014
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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…