Licenses, Permits and Regulations under the Act on Pharmaceuticals and Medical Devices and Other Applicable Laws
First written in FY2016. 3 of 5 entries say "Restated". Latest entry: FY2020.
The whole theme swung hardest in 2021: 2 of 14 companies on the "Worse" side.
0 other companies' latest entry also says "Mitigated".
- FY2020MitigatedAnnual report
「Our group has established a compliance charter, provides thorough employee training and works to ensure compliance with laws and regulations.」
The compliance charter and employee training addressing legal and licensing risks are clearly described. - FY2019RestatedAnnual report
「The Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices and Other Products (the Pharmaceuticals and Medical Devices Act), together with related laws and regulations, requires the registration and designation of licenses and permits, as well as various approvals and permits relating to development, manufacturing and imports.」
The risk that licensing, permitting and regulatory requirements under the Pharmaceuticals and Medical Devices Act and other laws could affect performance remains in place. - FY2018RestatedAnnual report
「The Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices and Other Products (the Pharmaceuticals and Medical Devices Act), together with related laws and regulations, requires the registration and designation of licenses and permits, as well as various approvals and permits relating to development, manufacturing and imports.」
The possibility that licensing, permitting and regulatory requirements under the Pharmaceuticals and Medical Devices Act and other laws could affect operating results is reiterated. - FY2017RestatedAnnual report
「In conducting business activities, the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices and Other Products (the Pharmaceuticals and Medical Devices Act), together with related laws and regulations, requires the registration and designation of licenses and permits, as well as various approvals and permits relating to development, manufacturing and imports.」
The possibility that licensing, permitting and regulatory requirements under the Pharmaceuticals and Medical Devices Act and other laws could affect operating results is reiterated. - FY2016First statedAnnual report
「In conducting business activities, the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices and Other Products (the Pharmaceuticals and Medical Devices Act), together with related laws and regulations, requires the registration and designation of licenses and permits, as well as various approvals and permits relating to development, manufacturing and imports.」
The status of licenses, permits and regulatory authorities could affect operating results.