Risk of Changes to the Pharmaceuticals and Medical Devices Act and Other Regulations
First written in FY2024. 1 of 2 entries say "Restated". Latest entry: FY2026.
The whole theme swung hardest in 2022: 3 of 16 companies on the "Worse" side.
17 other companies' latest entry also says "Restated".
- FY2026RestatedAnnual report
「If, as a result of revisions to laws and regulations not initially anticipated during the research and development period, the regulatory authorities do not recognize the product as a pharmaceutical or medical device, approval may not be obtained as planned, making commercialization difficult.」
The risk that changes to the Act on Pharmaceuticals and Medical Devices and other regulations could affect approval, commercialization and licensing-out continues to be disclosed. - FY2024First statedAnnual report
「If, as a result of revisions to laws and regulations not initially anticipated during the research and development period, the regulatory authorities do not recognize the product as a pharmaceutical or medical device, approval may not be obtained as planned, making commercialization difficult.」
For the first time, the risk that changes to the Act on Pharmaceuticals and Medical Devices, pharmaceutical regulatory guidance, the health insurance system and other regulations could affect approval, commercialization and licensing-out terms has been disclosed as a separate item.