Pharmaceutical Regulations and Ongoing Licensing Requirements
First written in FY2016. 24 of 25 entries say "Restated". Latest entry: FY2024.
The whole theme swung hardest in 2021: 2 of 14 companies on the "Worse" side.
16 other companies' latest entry also says "Restated".
- FY2024RestatedAnnual report
「Although we take thorough measures to comply with the Pharmaceuticals and Medical Devices Act and other applicable laws and regulations, our business activities may be restricted if our marketing authorization is revoked, we are ordered to suspend operations or improve our operations, or new or revised laws and regulations are introduced.」
The risks of pharmaceutical regulations, revocation of licenses and permits, and suspension of operations continue to be disclosed. - FY2024-Q3RestatedAnnual report
「During the cumulative period of the third quarter, there were no occurrences of the major risks that management recognizes as potentially having a material impact on the company's financial position, operating results or cash flows, among matters concerning the business and accounting conditions described in this quarterly report, nor were there any material changes to the section entitled "Business and Other Risks" in the annual securities report for the previous fiscal year.」
It states that there have been no material changes in the key risks, including the continuation of pharmaceutical regulations, licenses and permits. - FY2024-Q1RestatedAnnual report
「During the cumulative period of the first quarter, there were no occurrences of the major risks that management recognizes as potentially having a material impact on the company's financial position, operating results or cash flows, among matters concerning the business and accounting conditions described in this quarterly report, nor were there any material changes to the section entitled "Business and Other Risks" in the annual securities report for the previous fiscal year.」
It states that there have been no material changes in the key risks, including the continuation of pharmaceutical regulations, licenses and permits. - FY2023-Q3RestatedAnnual report
「During the cumulative period of the third quarter, there were no occurrences of the major risks that management recognizes as potentially having a material impact on the company's financial position, operating results or cash flows, among matters concerning the business and accounting conditions described in this quarterly report, nor were there any material changes to the section entitled "Business and Other Risks" in the annual securities report for the previous fiscal year.」
It states that there have been no material changes in the key risks, including the continuation of pharmaceutical regulations, licenses and permits. - FY2023-Q2RestatedAnnual report
「During the cumulative period of the second quarter, there were no occurrences of the major risks that management recognizes as potentially having a material impact on the company's financial position, operating results or cash flows, among matters concerning the business and accounting conditions described in this quarterly report, nor were there any material changes to the section entitled "Business and Other Risks" in the annual securities report for the previous fiscal year.」
It states that there have been no material changes in the key risks, including the continuation of pharmaceutical regulations, licenses and permits. - FY2023-Q1RestatedAnnual report
「During the cumulative period of the first quarter, there were no occurrences of the major risks that management recognizes as potentially having a material impact on the company's financial position, operating results or cash flows, among matters concerning the business and accounting conditions described in this quarterly report, nor were there any material changes to the section entitled "Business and Other Risks" in the annual securities report for the previous fiscal year.」
It states that there have been no material changes in the key risks, including the continuation of pharmaceutical regulations, licenses and permits. - FY2022-Q3RestatedAnnual report
「During the cumulative period of the third quarter, there were no occurrences of the major risks that management recognizes as potentially having a material impact on the company's financial position, operating results or cash flows, among matters concerning the business and accounting conditions described in this quarterly report, nor were there any material changes to the section entitled "Business and Other Risks" in the annual securities report for the previous fiscal year.」
It states that there have been no material changes in the key risks, including the continuation of pharmaceutical regulations, licenses and permits. - FY2022-Q2RestatedAnnual report
「During the cumulative period of the second quarter, there were no occurrences of the major risks that management recognizes as potentially having a material impact on the company's financial position, operating results or cash flows, among matters concerning the business and accounting conditions described in this quarterly report, nor were there any material changes to the section entitled "Business and Other Risks" in the annual securities report for the previous fiscal year.」
It states that there have been no material changes in the key risks, including the continuation of pharmaceutical regulations, licenses and permits. - FY2021-Q3RestatedAnnual report
「During the cumulative period of the third quarter, there were no occurrences of the major risks that management recognizes as potentially having a material impact on the company's financial position, operating results or cash flows, among matters concerning the business and accounting conditions described in this quarterly report, nor were there any material changes to the section entitled "Business and Other Risks" in the annual securities report for the previous fiscal year.」
It states that there have been no material changes in the key risks, including the continuation of pharmaceutical regulations, licenses and permits. - FY2021-Q2RestatedAnnual report
「During the cumulative period of the second quarter, there were no occurrences of the major risks that management recognizes as potentially having a material impact on the company's financial position, operating results or cash flows, among matters concerning the business and accounting conditions described in this quarterly report, nor were there any material changes to the section entitled "Business and Other Risks" in the annual securities report for the previous fiscal year.」
It states that there have been no material changes in the key risks, including the continuation of pharmaceutical regulations, licenses and permits. - FY2021-Q1RestatedAnnual report
「During the cumulative period of the first quarter, there were no occurrences of the major risks that management recognizes as potentially having a material impact on the company's financial position, operating results or cash flows, among matters concerning the business and accounting conditions described in this quarterly report, nor were there any material changes to the section entitled "Business and Other Risks" in the annual securities report for the previous fiscal year.」
It states that there have been no material changes in the key risks, including the continuation of pharmaceutical regulations, licenses and permits. - FY2020-Q2RestatedAnnual report
「During the cumulative second quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes in existing risks, including ongoing pharmaceutical regulations and licensing requirements. - FY2020-Q1RestatedAnnual report
「During the cumulative first quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes in existing risks, including ongoing pharmaceutical regulations and licensing requirements. - FY2019RestatedAnnual report
「The company strictly complies with the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and related regulations. However, if it violates that Act, other laws and regulations concerning pharmaceutical affairs, the Poisonous and Deleterious Substances Control Act or other applicable laws, its permits could be revoked, or it could be ordered to suspend all or part of its operations for a specified period.」
It continues to disclose the risk of pharmaceutical regulatory violations resulting in the revocation of permits or suspension of operations. Permits are renewed every 5 years. - FY2019-Q3RestatedAnnual report
「During the cumulative third quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes in existing risks, including ongoing pharmaceutical regulations and licensing requirements. - FY2019-Q2RestatedAnnual report
「During the cumulative second quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes in existing risks, including ongoing pharmaceutical regulations and licensing requirements. - FY2019-Q1RestatedAnnual report
「During the cumulative first quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes in existing risks, including ongoing pharmaceutical regulations and licensing requirements. - FY2018-Q3RestatedAnnual report
「During the cumulative third quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes in existing risks, including ongoing pharmaceutical regulations and licensing requirements. - FY2018-Q2RestatedAnnual report
「During the cumulative second quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes in existing risks, including ongoing pharmaceutical regulations and licensing requirements. - FY2018-Q1RestatedAnnual report
「During the cumulative first quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes in existing business and other risks, including ongoing pharmaceutical regulations and licensing requirements. - FY2017RestatedAnnual report
「As of now, no event has occurred that would hinder the continuation of the company's business activities.」
It describes the continuing risk associated with pharmaceutical regulations and licensing requirements and states that no event currently exists that would hinder business continuity. - FY2017-Q3RestatedAnnual report
「During the cumulative third quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes in existing risks, including ongoing pharmaceutical regulations and licensing requirements. - FY2017-Q2RestatedAnnual report
「During the cumulative second quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It explicitly states that there have been no material changes in the risks described in the previous fiscal year, including ongoing pharmaceutical regulations and licensing requirements. - FY2017-Q1RestatedAnnual report
「During the cumulative first quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It explicitly states that there have been no material changes in the risks described in the previous fiscal year, including ongoing pharmaceutical regulations and licensing requirements. - FY2016First statedAnnual report
「Although we strictly comply with the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and related regulations, if we violate that Act or other pharmaceutical-related laws, or the Poisonous and Deleterious Substances Control Act, our licenses could be revoked or we could be ordered to suspend all or part of our operations for a specified period.」
Recognizes regulatory risks that could result in license revocation or suspension of operations.