Will an “off-year” drug price revision happen in April 2025 or not? Over the last week, expectations have been up…
ORGANIZATION
Japan Citizens’ Group Opposes RWD-Only Drug Submissions
A citizens drug damage watchdog, Medwatcher Japan, issued a statement to the health minister on December 12 opposing the amendment of the Pharmaceuticals and Medical Devices (PMD) Act to allow regulatory submissions based solely on real-world data (RWD). The statement…
To read the full story
Related Article
ORGANIZATION
- Japan Citizens’ Group Opposes RWD-Only Drug Submissions
December 16, 2024
- EFPIA Japan Issues Joint Statement for Resolving Drug Lags/Losses
December 12, 2024
- Pharma Labor Group Petitions MHLW to Scrap Off-Year Revisions
December 3, 2024
- DPP Head, Industry Leaders United towards Stopping Off-Year Price Revisions
November 29, 2024
- PhRMA Wants No Off-Year Price Cuts, Urges Japan Not to Backslide: Chair
November 28, 2024
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…
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…