Japan’s ruling coalition sustained a crushing blow in the Lower House election last month, only managing to win 215 seats,…
REGULATORY
Accession Requirements for ICH Assembly Hammered Out at Fukuoka Confab
The International Conference on Harmonization (ICH) agreed on the eligibility requirements for members of a newly set up ICH assembly at its meeting in Fukuoka, southwestern Japan. At the meeting, held for six days through June 11, the ICH agreed…
To read the full story
Related Article
- Q&A Document on GMP for APIs Reaches Step 4: ICH Meeting in Fukuoka
July 13, 2015
- ICH Likely to OK Brazil, China as Assembly Members at Fukuoka Confab
May 26, 2015
- MHLW Releases Discussion Outline of ICH Lisbon Meeting
December 18, 2014
- Outline of New Global Clinical Trial Guidelines Agreed On at ICH Confab in Lisbon
December 12, 2014
- ICH Makes Progress Toward Greater Inclusivity, Agrees to Establish Assembly at November Meeting in Lisbon
December 4, 2014
- Can a More-Open ICH Maintain “Tri-Polar” Leadership? - Key Focus at Lisbon Meeting
November 5, 2014
- ICH M7 Guideline Reaches Step 4; MHLW to Issue Notification
July 22, 2014
- ICH to Facilitate Participation of Regulatory Authorities from Non-ICH Regions in Future Activities
July 30, 2013
- eCTD Progresses to Step 4 at ICH in Brussels
July 18, 2013
- What Next for a “Mature” ICH? What More Can Be Done Beyond Regulatory Harmonization?
January 22, 2013
REGULATORY
- MHLW Proposes Upping Copay Limits in High-Cost Medical Expense Scheme
November 25, 2024
- Japan’s New Economic Package Covers Pharma-Related Steps, but Not Repeal of Off-Year Revisions
November 25, 2024
- AstraZeneca’s COVID Antibody, Daiichi’s TROP2 ADC, and More Up for Review on Dec. 6
November 25, 2024
- Pharma Renews Call for Abolishing Off-Year Revisions, but MHLW Stays Put with Honebuto
November 22, 2024
- Pharma Pushes to Scrap Off-Year Revisions; LDP Members Urge Fresh Talks by 4 Ministers
November 22, 2024
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…