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
- Novartis Pharma Taking Steps to “Clean Up Its Act” in Wake of Diovan Scandal: Minister of Health Tamura
June 5, 2013
- Study Group Fails to Reach Agreement on Online Sales of OTC Drugs; Final Report to Collate Different Views
June 4, 2013
- Provisional Measure Allowing Online Sales of Class 2 and 3 OTC Drugs to Be Extended to End of 2013: MHLW
June 4, 2013
- MHLW to Look into Correlations of Pediatric Drug Intakes and Adverse Reactions
June 3, 2013
- 14 APIs/26 Products Including Third Domestic Biosimilar Receive Listing
June 3, 2013
- FDA Approves World’s First MEK Inhibitor Discovered by JT
May 31, 2013
- Members of Study Group Say Ban on Use of Medical Information Database by Drug Makers Should Be Reconsidered After Trial Period Ends
May 31, 2013
- Expert Subcommittee to Begin Discussing Cost-Effective Assessments for Specific Medical Technologies
May 31, 2013
- H. pylori Eradication Could Greatly Reduce Medical Expenditure; Manufacturers of PPIs Will Need to Educate the Public
May 31, 2013
- Outline of Growth Strategy Embraces Japan-Version NIH, Promotion of Special System for Mixed Healthcare
May 30, 2013
- 45 Face-to-Face Consultation Meetings Provided through PMDA’s Regulatory Strategy Consultation Service as of March 2013
May 30, 2013
- MHLW Reprimands Novartis over Diovan Papers
May 29, 2013
- Report of MOF’s Fiscal System Council Calls for 100% Generic Share Target
May 29, 2013
- PAFSC’s Second Committee Recommends Approval for IV Preparation of Acetaminophen
May 28, 2013
- First Committee Recommends Approval for Third GLP-1 Receptor Agonist Lyxumia, Others
May 27, 2013
- “Strong Guidance Will Be Required” in Diovan Case: Health Minister Tamura
May 27, 2013
- Citations in Guidelines to Be Prerequisite for Health Coverage of Off-Label Drugs under 1980 Notification
May 24, 2013
- New Rules to Promote Generic Drug Use by Welfare Recipients to Take Effect This Year
May 23, 2013
- MOF Official Expresses Caution on Perpetuation of New Drug Premium, Citing “Need for Continual Verification”
May 22, 2013
- MHLW Orders Marketing Authorization Holders of Careram/Kolbet to Issue a “Blue Letter”
May 21, 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…