Risks Relating to Pharmaceutical Regulations, Revocation of Licenses and Permits, and Drug Price Reductions
First written in FY2016. 16 of 19 entries say "Restated". Latest entry: FY2026.
The whole theme swung hardest in 2018: 20 of 65 companies on the "Worse" side.
47 other companies' latest entry also says "Restated".
- FY2026RestatedAnnual report
「As of the present time, no grounds for revoking these licenses and approvals have arisen. However, if they are revoked due to violations of laws or regulations, the Group may be required to recall regulated products or discontinue their manufacture and sale.」
Continues to disclose the risks of license and approval revocations, recalls, the discontinuation of manufacturing and sales, and declining sales due to drug price revisions, while stating that no grounds for revocation have arisen as of the present time. - FY2024-Q3RestatedAnnual report
「During the cumulative third quarter under review, there were no significant changes in the matters described in this quarterly report regarding the business and accounting conditions that could materially affect investors’ decisions, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
Reconfirms that there were no material changes to the business and other risks, including pharmaceutical regulations, license and approval revocations, and drug price reductions. - FY2024-Q2RestatedAnnual report
「During the cumulative second quarter under review, there were no significant changes in the matters described in this quarterly report regarding the business and accounting conditions that could materially affect investors’ decisions, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
Reconfirms that there were no material changes to the business and other risks, including pharmaceutical regulations, license and approval revocations, and drug price reductions. - FY2023-Q2MaterialisedAnnual report
「The Company had submitted an application for marketing approval to Brazil's National Health Surveillance Agency (ANVISA) in December 2020, but the application was rejected in August 2022.」
The existing risks relating to pharmaceutical approvals include the fact that JR-141's application for approval in Brazil was rejected. - FY2022-Q2RestatedAnnual report
「During the cumulative second quarter under review, there were no significant changes in the matters described in this quarterly report regarding the business and accounting conditions that could materially affect investors’ decisions, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
Reconfirms that there were no material changes to the business and other risks, including pharmaceutical regulations, license and approval revocations, and drug price reductions. - FY2021-Q1RestatedAnnual report
「During the first quarter of the current consolidated cumulative period, there were no occurrences of matters that could materially affect investors’ investment decisions among the matters relating to the business and financial position described in this quarterly report, nor were there any material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
Reconfirms that there were no material changes to the business and other risks, including pharmaceutical regulations, license and approval revocations, and drug price reductions. - FY2020RestatedAnnual report
「The Company is working to comply with the various conditions for obtaining these licenses and approvals and with applicable laws and regulations, and as of the present time, no grounds for revoking them have arisen.」
Continues to disclose the risks of license and approval revocations, product recalls, the discontinuation of manufacturing and sales, and fluctuations in selling prices due to drug price revisions, while stating that no grounds for revocation have arisen as of the present time. - FY2020-Q3RestatedAnnual report
「During the cumulative third quarter under review, there were no significant changes in the matters described in this quarterly report regarding the business and accounting conditions that could materially affect investors’ decisions, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
Reconfirms that there were no material changes to the business and other risks, including pharmaceutical regulations, license and approval revocations, and drug price reductions. - FY2020-Q2RestatedAnnual report
「During the cumulative second quarter under review, there were no significant changes in the matters described in this quarterly report regarding the business and accounting conditions that could materially affect investors’ decisions, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
Reconfirms that there were no material changes to the business and other risks, including pharmaceutical regulations, license and approval revocations, and drug price reductions. - FY2020-Q1RestatedAnnual report
「During the first quarter of the current consolidated cumulative period, there were no occurrences of matters that could materially affect investors’ investment decisions among the matters relating to the business and financial position described in this quarterly report, nor were there any material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
Reconfirms that there were no material changes to the business and other risks, including pharmaceutical regulations, license and approval revocations, and drug price reductions. - FY2019RestatedAnnual report
「As of the present time, no grounds for revoking these licenses and approvals have arisen. However, if they are revoked due to violations of laws or regulations, the Group may be required to recall regulated products or discontinue their manufacture and sale, which could have a material impact on the Group's business.」
Continues to disclose the risks of license and approval revocations, product recalls, the discontinuation of manufacturing and sales, and drug price reductions. - FY2019-Q3RestatedAnnual report
「During the cumulative third quarter under review, there were no significant changes in the matters described in this quarterly report regarding the business and accounting conditions that could materially affect investors’ decisions, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
Reconfirms that there were no material changes to the business and other risks, including pharmaceutical regulations, licenses and approvals, and drug prices. - FY2019-Q2RestatedAnnual report
「During the cumulative second quarter under review, there were no significant changes in the matters described in this quarterly report regarding the business and accounting conditions that could materially affect investors’ decisions, or in the “Business and Other Risks” described in the securities report for the previous fiscal year.」
States that there were no material changes to the business and other risks and reaffirms the existing risks relating to pharmaceutical regulations, licenses and approvals, and drug prices. - FY2019-Q1RestatedAnnual report
「During the first quarter of the current consolidated cumulative period, there were no occurrences of matters that could materially affect investors’ investment decisions among the matters relating to the business and financial position described in this quarterly report, nor were there any material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
States that there were no material changes to the business and other risks and reaffirms the existing risks relating to pharmaceutical regulations, licenses and approvals, and drug prices. - FY2018RestatedAnnual report
「The Group is working to comply with the various conditions for obtaining these licenses and approvals and with applicable laws and regulations, and as of the present time, no grounds for revoking them have arisen. However, if the licenses and approvals are revoked due to violations of laws or regulations, the Group may be required to recall regulated products or discontinue their manufacture and sale, which could have a material impact on the Group's business.」
Continues to disclose the risks of license and approval revocations, recalls, the discontinuation of manufacturing and sales, and drug price reductions, while stating that no grounds for revocation have arisen as of the present time. - FY2018-Q1RestatedAnnual report
「During the first quarter of the current consolidated cumulative period, there were no occurrences of matters that could materially affect investors’ investment decisions among the matters relating to the business and financial position described in this quarterly report, nor were there any material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
States that there were no material changes to the business and other risks, including pharmaceutical regulations, license and approval revocations, and drug price reductions. - FY2017-Q3RestatedAnnual report
「During the cumulative third quarter under review, the business environment for the pharmaceutical industry became increasingly challenging as the government's policies to contain medical costs continued and drug prices were revised in April last year.」
Reaffirms the challenging business environment resulting from drug price revisions and policies to contain medical costs. States that there were no material changes to the business and other risks themselves. - FY2017-Q1MaterialisedAnnual report
「During the cumulative first quarter under review, the business environment for the pharmaceutical industry became increasingly challenging as the government's policies to contain medical costs continued and drug prices were revised in April this year.」
States that the existing risk of drug price reductions materialized as drug prices were revised in April 2016, affecting the business environment. - FY2016First statedAnnual report
「If the Group's licenses and approvals are revoked due to violations of laws or regulations, it may be required to recall regulated products or discontinue their manufacture and sale, which could have a material impact on the Group's business. In addition, revisions to the National Health Insurance drug price schedule, including price reductions, put downward pressure on supply prices at the distribution stage and may cause fluctuations in the Group's selling prices.」
States that license and approval revocations, product recalls, the discontinuation of manufacturing and sales, and drug price reductions may affect financial results.