Risk of regulation and revocation of regulatory approvals and licenses under the Pharmaceuticals and Medical Devices Act and other laws and regulations
First written in FY2016. 11 of 13 entries say "Restated". Latest entry: FY2020.
The whole theme swung hardest in 2026: 4 of 7 companies on the "Worse" side.
1 other company's latest entry also says "Other".
- FY2020Classifies regulatory risks as particularly important risksAnnual report
「Regulatory and Legal Compliance ※ Particularly important risk ・If any business license under the PMD Act or similar laws in countries where the Company operates is violated and revoked, products subject to regulation may be recalled, sales may be suspended, and the relevant business activities may be suspended」
Classifies the existing regulatory risk under the PMD Act and other laws, including overseas laws and regulations, as a particularly important risk, and identifies review procedures by the regulatory affairs, quality assurance and legal departments as countermeasures. - FY2020-Q3RestatedAnnual report
「There were no newly arising business or other risks during the cumulative consolidated period for the third quarter. Nor were there any material changes to the business or other risks described in the securities report for the previous fiscal year.」
States that there have been no significant changes regarding the risk of regulations under the PMD Act and other laws or the revocation of approvals and licenses. - FY2020-Q2RestatedAnnual report
「During the six-month period ended the second quarter of the current consolidated fiscal year, there were no new business risks or material changes to the business risks described in the previous fiscal year's Annual Securities Report.」
States that there have been no significant changes regarding the risk of regulations under the PMD Act and other laws or the revocation of approvals and licenses. - FY2020-Q1RestatedAnnual report
「There were no newly arising business or other risks during the cumulative consolidated period for the first quarter. Nor were there any material changes to the business or other risks described in the securities report for the previous fiscal year.」
States that there have been no significant changes regarding the risk of regulations under the PMD Act and other laws or the revocation of approvals and licenses. - FY2019-Q3RestatedAnnual report
「There were no newly arising business or other risks during the cumulative consolidated period for the third quarter. Nor were there any material changes to the business or other risks described in the securities report for the previous fiscal year.」
States that there have been no significant changes regarding the risk of regulations under the PMD Act and other laws or the revocation of approvals and licenses. - FY2019-Q2RestatedAnnual report
「During the six-month period ended the second quarter of the current consolidated fiscal year, there were no new business risks or material changes to the business risks described in the previous fiscal year's Annual Securities Report.」
States that there have been no significant changes regarding the risk of regulations under the PMD Act and other laws or the revocation of approvals and licenses. - FY2019-Q1RestatedAnnual report
「There were no newly arising business or other risks during the cumulative consolidated period for the first quarter. Nor were there any material changes to the business or other risks described in the securities report for the previous fiscal year.」
States that there have been no significant changes regarding the risk of regulations under the PMD Act and other laws or the revocation of approvals and licenses. - FY2018-Q3RestatedAnnual report
「There were no newly arising business or other risks during the cumulative consolidated period for the third quarter. Nor were there any material changes to the business or other risks described in the securities report for the previous fiscal year.」
States that there have been no significant changes regarding the risk of regulations under the PMD Act and other laws or the revocation of approvals and licenses. - FY2018-Q2RestatedAnnual report
「During the six-month period ended the second quarter of the current consolidated fiscal year, there were no new business risks or material changes to the business risks described in the previous fiscal year's Annual Securities Report.」
States that there have been no significant changes regarding the risk of regulations under the PMD Act and other laws or the revocation of approvals and licenses. - FY2018-Q1RestatedAnnual report
「During the first quarter of the current consolidated fiscal year, there were no newly arising business or other risks, and no material changes to the business or other risks described in the securities report for the previous fiscal year.」
States that there have been no significant changes regarding the risk of regulations under the PMD Act and other laws or the revocation of approvals and licenses. - FY2017-Q3RestatedAnnual report
「There were no newly arising business or other risks during the cumulative consolidated period for the third quarter. Nor were there any material changes to the business or other risks described in the securities report for the previous fiscal year.」
States that there have been no significant changes regarding the risk of regulations under the PMD Act and other laws or the revocation of approvals and licenses. - FY2017-Q1RestatedAnnual report
「During the first quarter of the current consolidated fiscal year, there were no newly arising business or other risks, and no material changes to the business or other risks described in the securities report for the previous fiscal year.」
States that there have been no significant changes regarding the risk of regulations under the PMD Act and other laws or the revocation of approvals and licenses. - FY2016First statedAnnual report
「The contact lens and lens care products business involves highly controlled medical devices and quasi-drugs and is subject to regulations under the PMD Act and other laws. Depending on the nature of amendments to those laws, the amendments could have a material impact on the operating results and financial position of the Company's group.」
States that amendments to laws and regulations or revocation of approvals and licenses could lead to product recalls, suspension of sales, or suspension of business activities.