Unpredictable post-marketing adverse-event risk
First written in FY2016. 3 of 5 entries say "Mitigated", first in FY2020. Latest entry: FY2024.
The whole theme swung hardest in 2026: 6 of 22 companies on the "Worse" side.
10 other companies' latest entry also says "Mitigated".
- FY2024MitigatedAnnual report
「The Group works to minimize pharmaceutical risks and promote appropriate use by collecting and evaluating safety information from Japan and overseas, including adverse-event information, and taking necessary safety measures in a timely manner, such as revising precautions for use. It has also established a committee to respond promptly to serious safety incidents and internal rules covering procedures to follow when a product recall occurs, creating a framework under which the relevant departments coordinate their response if a risk materializes.」
The disclosure systematically describes the collection and evaluation of information from Japan and overseas, revisions to precautions, a committee for responding to serious incidents and recall procedures as measures addressing adverse-event risk. - FY2023MitigatedAnnual report
「To minimize risks related to adverse events, the Group continually assesses the benefit-risk profile of its medicines and takes timely measures, including revising precautions for use. It has also established internal rules covering a committee that responds to health damage caused by adverse events and procedures to follow when a product recall occurs, creating a framework under which the relevant departments coordinate their response if a risk materializes.」
The company explicitly describes its response to adverse-event risk, including benefit-risk assessments, revisions to precautions for use, a response committee and recall procedures. - FY2021RestatedAnnual report
「The Group maintains appropriate insurance to cover various liabilities, including product liability, in preparation for risks such as adverse events. It has also established and operates a response committee and set out operating procedures, creating a framework under which the relevant departments coordinate their response, led by the committee, if a risk materializes.」
The company reiterates its insurance coverage and response framework centered on a response committee for adverse-event risk. - FY2020MitigatedAnnual report
「The Group maintains appropriate insurance to cover various liabilities, including product liability, in preparation for risks such as adverse events. It has also established and operates a response committee and set out operating procedures, creating a framework under which the relevant departments coordinate their response, led by the committee, if a risk materializes.」
The disclosure describes insurance coverage and a response framework centered on a response committee for post-marketing adverse-event risk. - FY2016First statedAnnual report
「However, if previously unanticipated adverse events emerge after marketing, forcing the company to discontinue sales and recall the product, the Group's operating results could be affected.」
The company identifies the emergence of post-marketing adverse events as a risk even after pre-approval testing and review.