HOME > REGULATORY
REGULATORY
- PMDA’s New Mid-Term Plan to Push Pediatric, Orphan Drug Development to Counter Losses
October 23, 2023
- Japan to Continue Accepting GLP Data from UK under New Bilateral Deal: MHLW
October 23, 2023
- Chuikyo Wants Sakigake Premium Review as a Package with Regulatory Reform
October 23, 2023
- China Formally Arrests Astellas Employee, Japan Urges Immediate Release
October 20, 2023
- Japan to Buy 10 Million More Doses of Pfizer/Moderna COVID Jabs
October 19, 2023
- Health Minister Requests 8 Makers to Bolster Supplies of Antitussive, Expectorant Agents
October 19, 2023
- Leqembi’s Initial Pricing Won’t Factor in Benefits in Long-Term Care
October 19, 2023
- Chuikyo at Odds over Handling of Startups in PMP, Timing of Deferred Price Cuts
October 19, 2023
- Medipharma Might Face Administrative Penalty over Trial Data Tampering
October 18, 2023
- Average Price Gap for 2024 Revision Looks to Be Lower than 7.0%: Wholesalers
October 18, 2023
- AMED Group to Draft Master Protocols Guidelines by March-End, Frets Further Drug Lag/Loss
October 17, 2023
- MHLW Sets Up Hotline for Production Site Change for Supply-Crippled Drugs
October 17, 2023
- Health Minister Laments Drug Lag/Loss, Stresses Need for Govt-Driven Innovation Ecosystem
October 16, 2023
- MHLW Regulatory Panel OKs New Procedures for Post-Approval Manufacturing Changes
October 16, 2023
- Japan’s New Economic Package to Include Dementia Measures: PM
October 16, 2023
- Xarelto’s Label Expansion Up for Japan Panel Review on Oct. 27
October 16, 2023
- MHLW to Swiftly Deliberate Additional Purchase of COVID Jabs: Minister
October 16, 2023
- Label Revisions Ordered for G-CSF Agents, Yervoy and More
October 13, 2023
- MHLW Preparatory Council Boots Up for Japan-Version of CDC
October 13, 2023
- MHLW Panel Proposes Assessing Generic Makers’ Efforts toward Stable Supplies, Reflecting Results in Pricing
October 12, 2023
ページ
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…
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…
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…