Regulatory Changes and Approval Delays for Pharmaceuticals and Regenerative Medicine Products
First written in FY2023. 2 of 3 entries say "Restated". Latest entry: FY2025.
The whole theme swung hardest in 2022: 3 of 16 companies on the "Worse" side.
17 other companies' latest entry also says "Restated".
- FY2025RestatedAnnual report
「Regulators may require additional testing or approval may be delayed, and if a product is not accepted by the regulator as a pharmaceutical or other regulated product, commercialization itself may become difficult.」
The company reiterates the risks of regulatory changes, additional testing, approval delays, difficulty commercializing products and changes to out-licensing terms. - FY2024RestatedAnnual report
「Regulators may require additional testing or approval may be delayed, and if a product is not accepted by the regulator as a pharmaceutical or other regulated product, commercialization itself may become difficult.」
The company reiterates the risks of regulatory changes, additional testing, approval delays, difficulty commercializing products and changes to out-licensing terms. - FY2023First statedAnnual report
「Regulations may be revised during the research and development period, and regulators may require additional testing or approval may be delayed because of factors not anticipated when the plan was prepared.」
The company identifies the risks of pharmaceutical regulations in various countries, additional testing, approval delays and uncertainty over reimbursement listing.