For 25 years, Morunda has been interviewing leaders in Japan’s pharmaceutical and medical device industry. Most country managers typically come from a commercial background, rooted in sales and marketing. It’s rare to find country managers who come from finance or…
HOME > REGULATORY
REGULATORY
- Komeito Lawmakers Call for Assessing Shionogi’s Pill for Circulating Strains
July 22, 2022
- Japan Plans Smaller Drug Price Survey for 2023 Revision, Just Like 2 Years Ago
July 21, 2022
- Imfinzi, Bavencio to Add Encephalitis Risks in Label Revision
July 21, 2022
- Janssen’s CAR-T Therapy, Kymriah Label Expansion Up for Review on Aug. 3
July 21, 2022
- Novo’s Rybelsus in for Price Cuts as Chuikyo OKs CEA Results
July 21, 2022
- Nuvaxovid Gets Label Update to Allow Primary Inoculations in Ages 12 and Older
July 21, 2022
- Japan Again Takes Pass on Emergency Approval for Shionogi’s COVID Pill as Panels Nix Presumed Efficacy
July 21, 2022
- Guidelines for Securing Key Resources Endorsed by LDP, Up for Cabinet Approval
July 20, 2022
- MHLW Official Sees More “Specified Clinical Research” Data Used in Regulatory Submissions to Fill Industry-Academia Void
July 20, 2022
- PMDA Head Fujiwara Re-Elected as ICMRA Vice Chair
July 20, 2022
- Taisho/Ablynx’s RA Med, BI’s Psoriasis Drug Up for MHLW Panel Review on July 29
July 19, 2022
- Japan Panel to Discuss 4th COVID Shot to Healthcare Providers: Health Minister
July 19, 2022
- MHLW Eyes Expert Panel Launch This Summer for Drug Distribution and Pricing: Official
July 19, 2022
- Japan Plans to Lower Minimum Age for Novavax Jab to 12
July 19, 2022
- MHLW Mulls Data Collection Policy for Conditionally Approved MSC Therapies
July 14, 2022
- Shionogi’s COVID-19 Pill Up for Expert Redeliberation on July 20
July 14, 2022
- Govt Council Calls for Steps to Beef Up Japan’s Clinical Trial System for Vaccines
July 13, 2022
- Accelerate Social Implementation of Genomic Medicine: Study Group
July 13, 2022
- 92 Defects/Health Damages Reported for Kymriah in October-March
July 13, 2022
- All 10 Pharma-Backed Candidates Grab Upper House Seats
July 12, 2022
ページ
Earlier this month, the Ministry of Finance (MOF) unveiled a long list of social security proposals towards the FY2025 budgeting,…
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…