Legal, Regulatory and Licensing Risks Relating to Regenerative Medical Products
First written in FY2023. 1 of 2 entries say "Worsened", first in FY2026. Latest entry: FY2026.
Cuorips moved to the "Worse" side of this theme in 2026, the same year as the typical company in this theme.
The whole theme swung hardest in 2022: 3 of 16 companies on the "Worse" side.
3 other companies' latest entry also says "Worsened".
- FY2026WorsenedAnnual report
「To develop, manufacture and sell regenerative medical products, including the cardiomyocyte sheet marketed under the name Reheart, the Group is subject to numerous domestic and overseas legal and regulatory requirements, including the Pharmaceuticals and Medical Devices Act, the Act on the Safety of Regenerative Medicine, the Product Liability Act, and the Waste Management and Public Cleansing Act.」
In addition to domestic manufacturing and marketing following approval, the company must address domestic and overseas regulations in anticipation of international expansion, broadening the scope of regulatory exposure. - FY2023First statedAnnual report
「To develop, manufacture and sell human iPS cell-derived cardiomyocyte sheets, we are subject to numerous legal and regulatory requirements, including the Pharmaceuticals and Medical Devices Act, the Act on the Safety of Regenerative Medicine, the Product Liability Act, and the Waste Management and Public Cleansing Act.」
The company states that violations could result in cancellation of licenses, suspension of operations, reputational damage, and additional costs arising from legal amendments or new regulations.