Uncertainty over New Product Development Discontinuation and Timing of Regulatory Approval in Each Country
First written in FY2016. 3 of 4 entries say "Restated". Latest entry: FY2024.
The whole theme swung hardest in 2022: 20 of 40 companies on the "Worse" side.
28 other companies' latest entry also says "Restated".
- FY2024RestatedAnnual report
「During the development period for new products, there is a risk that development may be discontinued if the expected efficacy and safety cannot be confirmed. In addition, regulatory approval must be obtained in each market before sales of a developed product can begin, but there is a risk that approval may not be obtained or may take longer than planned.」
The discontinuation of research and development and the uncertainty over the timing and feasibility of regulatory approval in each market continue to be disclosed. - FY2020RestatedAnnual report
「During the development period for new products, development may be discontinued if the expected efficacy and safety cannot be confirmed. In addition, regulatory approval must be obtained in each market before sales of a developed product can begin, but there is a risk that approval may not be obtained or may take longer than planned.」
The possibility of discontinuing research and development and the uncertainty over whether and how long it will take to obtain regulatory approval in each market are restated. - FY2017RestatedAnnual report
「Research and development of new products takes time, but development may be discontinued if the expected utility cannot be confirmed during that period. Medical devices are subject to the laws and regulations of each country and cannot be sold without obtaining approval in each market. It is also difficult to accurately predict whether approval will be obtained and when.」
The possibility of discontinuing research and development and the uncertainty over whether and when approvals can be obtained in each country are restated. - FY2016First statedAnnual report
「Research and development of new products takes time, but development may be discontinued if the expected utility cannot be confirmed during that period. Medical devices are subject to the laws and regulations of each country and cannot be sold without obtaining approval in each market. It is also difficult to accurately predict whether approval will be obtained and when.」
The ability to confirm the usefulness of research and development and the feasibility and timing of obtaining approvals are identified as uncertainties.