Risk of Changes in Pharmaceutical Regulations and Healthcare Insurance Systems
First written in FY2021. 3 of 4 entries say "Restated". Latest entry: FY2025.
The whole theme swung hardest in 2018: 20 of 65 companies on the "Worse" side.
47 other companies' latest entry also says "Restated".
- FY2025RestatedAnnual report
「As noted above, drug development requires a long period of time, and these standards, regulations, systems and other requirements may be revised or changed during that period.」
This reconfirms the risk that revisions to pharmaceutical regulations, the medical insurance system and other requirements may affect the research and development structure, clinical trials and funding needs. - FY2023RestatedAnnual report
「These standards, regulations, systems and other requirements may be revised or changed.」
This reconfirms the risk that revisions or changes to drug approval standards, pharmaceutical regulations, the medical insurance system and other requirements may affect research and development and earnings. - FY2022RestatedAnnual report
「Depending on developments in future policies to control medical costs, marketed drugs may not receive the appropriate reimbursement prices assumed, and expected royalties may not be obtained, which could affect the Company's operating results and financial position.」
This reconfirms, in the form of specific medical cost-containment policies, the risk that changes in pharmaceutical regulations and the medical insurance system may affect drug prices and royalties. - FY2021First statedAnnual report
「These standards, regulations, systems and other requirements may be revised or changed.」
This indicates that changes in regulations or systems may require changes to manufacturing methods, development approaches, clinical trial procedures or additional testing.