Risk of New Adverse Reactions Arising After Marketing
First written in FY2016. 1 of 3 entries say "Restated". Latest entry: FY2020.
The whole theme swung hardest in 2026: 6 of 20 companies on the "Worse" side.
8 other companies' latest entry also says "Mitigated".
- FY2020MitigatedAnnual report
「The Group formulates a risk management plan for each pharmaceutical product and continuously collects and evaluates safety information, including adverse reactions. After assessing the seriousness of the information collected and the need for warnings, the Group implements safety measures as necessary, such as revising the “Precautions for Use” section of package inserts and providing notices concerning the proper use of pharmaceuticals.」
In response to the risk of new post-marketing adverse reactions, the Group details measures including product-specific risk management plans, information collection and assessment, and revisions to package inserts. - FY2018RestatedAnnual report
「New adverse reactions that were not experienced during the clinical trial stage may be reported after a pharmaceutical product is marketed.」
The possibility of new adverse reactions arising after marketing has again been identified as a risk specific to the pharmaceutical business. - FY2016First statedAnnual report
「New adverse reactions that were not experienced during the clinical trial stage may be reported after a pharmaceutical product is marketed.」
New post-marketing adverse reactions that cannot be identified during clinical trials are identified as a risk specific to the pharmaceutical business.