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
- Chuikyo to Discuss Exclusion of Long-Listed Biologics from New Coverage Scheme
January 29, 2024
- Japan’s Diet Kicks Off 150-Day Regular Session, MHLW Plans 4 Bills
January 29, 2024
- Jardiance’s CKD Indication in Line for Japan Approval with Key Panel Nod
January 29, 2024
- Break-Up of LDP Factions Won’t Have Major Impact on Pharma Policy, but Could Make Lobbying Tougher
January 26, 2024
- MHLW Holds 1st Meeting to Consider Structure of Japan CDC
January 26, 2024
- MHLW No Longer Requires Japanese Comparability Data for Certain Biosimilars: Q&A Update
January 26, 2024
- Cases of Xocova Use in Pregnant Women Now Total 34: MHLW
January 24, 2024
- As Japan Sees Uptick in COVID Cases, Minister Says to Watch Situations
January 24, 2024
- PMDA Sets 6-Month Target for All SaMD Products under Priority Review
January 23, 2024
- Label Expansion for Opdivo, Olumiant, Dupixent Up for PAFSC Review on Feb. 5
January 23, 2024
- MHLW Urges Prioritized Delivery of Drugs under Shipment Control to Ishikawa
January 22, 2024
- Requests Raised on LLP Coverage Rule, Supply Issue: Chuikyo Public Hearing
January 22, 2024
- PMDA Reviewing Safety Risks for 12 Drugs including Kinase Inhibitors
January 22, 2024
- Japan Approves Pfizer’s RSV Jab, Ultragenyx’s Evkeeza, and More
January 19, 2024
- Market Expansion Re-Pricing to Hit 23 Meds in April, Opdivo Faces Yet Another Cut in Spillover
January 18, 2024
- Updated Rules OK’ed for FY2024 Reform, 5-10% Rate Set for New Premium to Counter Lag/Loss
January 18, 2024
- 9 APIs to Earn Increased Premiums in FY2024 Price Revision; Jakavi Gets Multiple Premiums
January 18, 2024
- MHLW Publishes Report on Drug Marketing System towards PMD Law Amendment
January 17, 2024
- MHLW Issues Notification to Clarify Orphan Designation Criteria
January 17, 2024
- FY2024 Reform Will Bolster Rewards for Innovation to Eradicate Drug Lag/Loss: LDP Policy Bigwig
January 16, 2024
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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…