Risk of Obtaining Regulatory Approval Due to Pharmaceutical Regulations and Clinical Trials
First written in FY2016. 11 of 13 entries say "Restated". Latest entry: FY2023-Q3.
The whole theme swung hardest in 2022: 3 of 16 companies on the "Worse" side.
17 other companies' latest entry also says "Restated".
- FY2023-Q3RestatedAnnual report
「During the cumulative third-quarter period, there were no new business risks and no material changes in the business risks described in the annual securities report for the preceding fiscal year.」
The Company has disclosed that there have been no material changes regarding the risk of failure to obtain approval due to pharmaceutical regulations and clinical trials. - FY2022WorsenedAnnual report
「The current Pharmaceuticals and Medical Devices Act permits the outsourced manufacture of active pharmaceutical ingredients. However, if regulations on such outsourced manufacturing or on the import of products from overseas are revised in the future, this could have a material impact on the Company's business activities.」
The Company explicitly states that, in addition to the existing approval risk, revisions to regulations governing outsourced manufacturing and the import of products from overseas could affect its business activities, thereby broadening the scope of regulatory risk. - FY2020RestatedAnnual report
「Accordingly, if the Company is unable to demonstrate the quality, efficacy and safety required of a pharmaceutical product in clinical trials or otherwise, it may be unable to obtain approval or launch the product, which could have a material impact on its business plan.」
The Company continues to disclose the risk of failure to obtain approval, subject to pharmaceutical regulations, clinical trials, and the demonstration of quality, efficacy and safety. - FY2019RestatedAnnual report
「Accordingly, if the Company is unable to demonstrate the quality, efficacy and safety required of a pharmaceutical product in clinical trials or otherwise, it may be unable to obtain approval or launch the product, which could have a material impact on its business plan.」
The Company continues to disclose the risk of failure to obtain approval, subject to pharmaceutical regulations, clinical trials, and the demonstration of quality, efficacy and safety. - FY2019-Q1RestatedAnnual report
「During the cumulative first-quarter period, there were no new business or other risks and no material changes to the business or other risks described in the annual securities report for the previous fiscal year.」
The Company has disclosed that there have been no material changes regarding the risk of failure to obtain approval due to pharmaceutical regulations and clinical trials. - FY2018RestatedAnnual report
「Accordingly, if the Company is unable to demonstrate the quality, efficacy and safety required of a pharmaceutical product in clinical trials or otherwise, it may be unable to obtain approval or launch the product, which could have a material impact on its business plan.」
The Company continues to disclose the risk of failure to obtain approval, subject to pharmaceutical regulations, clinical trials, and the demonstration of quality, efficacy and safety. - FY2018-Q3RestatedAnnual report
「During the nine months ended September, there were no new business or other risks, nor any material changes to the business or other risks described in the securities report for the prior fiscal year.」
The Company has disclosed that there have been no new developments or material changes regarding the risk of failure to obtain approval due to pharmaceutical regulations and clinical trials. - FY2018-Q2RestatedAnnual report
「During the six months ended June, there were no new business or other risks, nor any material changes to the business or other risks described in the securities report for the prior fiscal year.」
The Company has disclosed that there have been no new developments or material changes regarding the risk of failure to obtain approval due to pharmaceutical regulations and clinical trials. - FY2017RestatedAnnual report
「If the Company is unable to demonstrate the quality, efficacy and safety required of a pharmaceutical product in clinical trials or otherwise, it may be unable to obtain approval or launch the product, which could have a material impact on its business plan.」
The annual report continues to disclose the risk that domestic and overseas pharmaceutical regulations, the demonstration of quality, efficacy and safety, and obtaining approval are prerequisites for the business plan. - FY2017-Q3RestatedAnnual report
「During the nine months ended September, there were no new business or other risks, nor any material changes to the business or other risks described in the securities report for the prior fiscal year.」
The Company has disclosed that there have been no new developments or material changes regarding the risk of failure to obtain approval due to pharmaceutical regulations and clinical trials. - FY2017-Q2RestatedAnnual report
「During the six months ended June, there were no new business or other risks, nor any material changes to the business or other risks described in the securities report for the prior fiscal year.」
The Company has disclosed that there have been no new developments or material changes regarding the risk of failure to obtain approval due to pharmaceutical regulations and clinical trials. - FY2017-Q1RestatedAnnual report
「During the three months ended March, there were no new business or other risks, nor any material changes to the business or other risks described in the securities report for the prior fiscal year.」
The Company has disclosed that there have been no material changes regarding the risk of failure to obtain approval due to pharmaceutical regulations and clinical trials. - FY2016First statedAnnual report
「If the Company is unable to demonstrate the quality, efficacy and safety required of a pharmaceutical product in clinical trials or otherwise, it may be unable to obtain approval or launch the product, which could have a material impact on its business plan.」
Domestic and overseas pharmaceutical laws and guidelines, approval applications, and the demonstration of quality, efficacy and safety are prerequisites for the development plan.