A total of 43 innovative new medicines are anticipated to be approved or listed in Japan this year, according to a survey by Jiho. At the center of attention are some highly innovative, but probably ultra-expensive, gene therapies, as well…
REGULATORY
Commentary: 1st Sakigake Drugs Picked via “Comparative Evaluation”, Will All Qualified Products Get Designated in the Future?
The designation of six drugs was announced for what is called the “sakigake” fast-track review system. With the system being rolled out on a pilot basis this year and regulators’ review structure short-handed, however, some products slipped out of the…
To read the full story
Related Article
- Keytruda, Novel Anti-Flu Drug Join Japan’s First Sakigake Designation List
October 28, 2015
- 6 Drugs Get Sakigake Designation for Fast-Track Review
October 27, 2015
- MHLW Likely to Announce 5 or So Sakigake Products Next Week
October 22, 2015
- One-Month Lag in Regulatory Filing Accepted for Sakigake Designation
September 24, 2015
- 51 Products Officially Filed for Sakigake Designation after MHLW Screening
September 18, 2015
- PMDA to Select Products for Sakigake Review; “Probably 5 to 10” Will Be Designated: Official
September 3, 2015
- Roughly 60 Products Submitted as Candidates for Review under Sakigake Designation System
June 8, 2015
REGULATORY
- Astellas’ Xtandi on 2nd Drug List Up for IRA Price Negotiations
January 21, 2025
- Lixiana Label Expansion on Agenda for MHLW Panel Session on Jan. 31
January 20, 2025
- MHLW Preparing to Submit Bill to Amend PMD Act in Mid-February
January 17, 2025
- CSL’s HAE Drug, Tecentriq Up for Panel Review on Jan. 30; 1st Cases of Expedited Approval
January 17, 2025
- Minimum NHI Prices to Be Raised by 3% Across the Board on April 1
January 16, 2025
A Japanese health ministry panel on December 26 wrapped up its discussions on the next amendment of the Pharmaceuticals and…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
In a recent conversation with James Feliciano, former president of AbbVie Japan, we delved into the intricacies of leadership in the Japanese pharmaceutical industry. Feliciano, a seasoned industry veteran, shared valuable insights into his experiences, challenges, and successes.Navigating the Abbott…
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…
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…