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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- Japan to Allow Submissions without Japanese Data If All Requirements Met
February 9, 2024
- FPMAJ Supports Generic Industry Consortia Concept but Frets Antitrust Issues
February 9, 2024
- Health Minister Admits Antitrust Challenge in Generic Industry Revamp
February 9, 2024
- Takeda’s Acquired Hemophilia A Drug Up for Panel Review on February 22
February 9, 2024
- New Govt Forum Moots US-Level Trial Environment, Priority Review Vouchers
February 9, 2024
- Generic Panel to Issue Report in Spring-Summer to Drive Manufacturing Efficiency towards Stable Supplies: Official
February 8, 2024
- Japan to Revamp Scheme for Drug Maker’s Reporting of Supply Concerns in April
February 7, 2024
- Legal Changes on Horizon for GMP Inspection Authorities, Other Regulation Panel Topics?
February 7, 2024
- Govt Eyes Boosted Manpower at AMED towards Next 5-Year Plan from FY2025
February 7, 2024
- AMED Needs More Manpower to Fulfill Its Role as Funding Agency: President
February 6, 2024
- Opdivo, Olumiant, Dupixent Now in Line for Label Expansions
February 6, 2024
- CSL’s Hemophilia Gene Therapy to Get Orphan Tag in Japan
February 6, 2024
- Truvada Clears Preliminary Review for PrEP Use, but Coverage Not Granted
February 6, 2024
- Generic Firms Required to Disclose Supply Info from June after Pilot Rollout of Company Indicators
February 5, 2024
- Will Truvada Win Health Coverage as Japan’s First Drug for HIV Prevention?
February 5, 2024
- MHLW to Kick Off Debates on PMD Act Amendment on Feb. 9
February 5, 2024
- Physician Meals Costs, Seminar Expenses Newly Subject to Disclosure under Clinical Trials Act from April
February 2, 2024
- Annual Drug Price Revisions Based on 4-Minister Agreement: Japan PM
February 2, 2024
- Japan to Introduce Fee Premium for Inpatient Biosimilar Use, Covering 13 APIs
February 1, 2024
- Drug Pricing, LLP Rule in MHLW’s Draft Supplementary Opinions for FY2024 Reform
February 1, 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…