The average gap between NHI prices and the market prices of listed medicines in Japan stood at a preliminary 5.2%…
REGULATORY
Japan to Require Drug Makers to Set Up Legal Post of “Stable Supply Manager”
A Japanese health ministry panel on November 28 agreed on a plan to legally require pharma companies to set up the post of “stable supply manager” through the next amendment of the Pharmaceuticals and Medical Devices (PMD) Act. The plan…
To read the full story
Related Article
- Advisory Panel Backs Transfer of GMP Inspection Authority for New Generics to PMDA
November 5, 2024
- Panel OKs Withdrawal Rule for Conditional Nod, 2-Year Extension for Pediatric Data Protection towards PMD Act Amendment
October 4, 2024
- MHLW Lays Out Updated Discussion Timeline for PMD Act Amendment
September 13, 2024
- MHLW Panel Discusses Ways to Rationalize Ethical Narcotics Distribution
July 30, 2024
- MHLW Panel Sets Topics for PMD Act Amendment; Pediatrics, Drug Loss on Agenda
April 19, 2024
REGULATORY
- CDP OKs Bill to Scrap Off-Year Revisions, Aims for Diet Submission Soon
December 13, 2024
- Chuikyo Doctor Rep Positive on Industry’s Behavioral Changes after 2024 Reform
December 12, 2024
- JGA to Compile Interim Report on Generic Industry Revamp in May
December 12, 2024
- Hearing Leaves Chuikyo Mixed on Off-Year Scheme, Political Decision Ever More Likely
December 12, 2024
- Ex-Minister Takemi to Set Up Nonprofit to Bolster Pharma Innovation
December 11, 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…