Use of the Conditional and Time-Limited Approval System
First written in FY2023. 3 of 8 entries say "Achieved", first in 2026-05-15. Latest entry: 2026-08-13.
0 other companies' latest entry also says "Advanced".
- 2026-08-13AdvancedEarnings presentation
「We aim to collect at least 75 post-marketing cases within 3 years and apply for full approval.」
条件及び期限付き承認後について、75例以上の市販後データ収集と本承認申請までの期間が具体的に示された。 - FY2026AchievedAnnual report
「For Reheart, the conditions and time limit require a post-marketing approval-conditions assessment through post-marketing surveillance and other measures covering all cases in which the product is used, 75 cases, during the 7-year period before resubmission of the marketing-approval application after conditional and time-limited approval.」
The company obtained approval under the conditional and time-limited approval system. Following approval, post-marketing surveillance and other assessments covering 75 cases over 7 years remain as approval conditions. - FY2025RestatedAnnual report
「Because our human iPS cell-derived cardiomyocyte sheet has these characteristics, we expect to use this system to obtain marketing approval.」
The company continued to aim for early approval through the conditional and time-limited approval system. - FY2024RestatedAnnual report
「Given these characteristics of our human iPS cell-derived cardiomyocyte sheet, we expect to use the conditional and time-limited approval system.」
The company continued to plan to use the conditional and time-limited approval system and to establish post-approval use-results surveillance and clinical-trial systems. - FY2023First statedAnnual report
「Given these characteristics of our human iPS cell-derived cardiomyocyte sheet, we expect to use the conditional and time-limited approval system.」
The company planned to use a system under which safety and a certain level of efficacy are confirmed using data from a small number of clinical-trial cases, followed by post-marketing verification of efficacy and safety, and planned to establish the required post-approval surveillance and clinical-trial systems.