Risks from Amendments to Pharmaceutical and Medical Device Regulations
First written in FY2016. 24 of 30 entries say "Restated". Latest entry: 2026-08-10.
3 other companies' latest entry also says "Restated".
- 2026-08-10RestatedEarnings
「In the pharmaceutical industry, measures to optimize medical costs, including pharmaceutical-system reforms and the further strengthening of policies to promote the use of generic drugs, continue to advance. As companies are required to further strengthen their management, the earnings environment is becoming increasingly challenging due to factors including higher R&D expenses and greater development risks.」
The company reiterated the challenging pharmaceutical earnings environment resulting from pharmaceutical-system reforms, stronger generic-drug promotion measures, higher R&D expenses and greater development risks. - FY2026-H1RestatedAnnual report
「In the pharmaceutical industry, measures to optimize medical costs, including pharmaceutical-system reforms and the further strengthening of policies to promote the use of generic drugs, continue to advance. As companies are required to further strengthen their management, the earnings environment is becoming increasingly challenging due to factors including higher R&D expenses and greater development risks.」
The Company continues to recognize that the challenging earnings environment will persist due to drug pricing system reforms, measures to encourage the use of generic drugs, and higher research and development expenses and development risks. - FY2024RestatedAnnual report
「As part of measures to contain healthcare costs, policies have been adopted to reduce the prices of prescription drugs and encourage the use of generic drugs, and such healthcare policies may have a material impact on the Company's business performance.」
The disclosure continues to describe the risks of prescription drug price reductions, promotion of generic drug use, revocation of approvals and licenses, and product recalls and discontinued sales resulting from legal violations. - FY2024-Q3RestatedAnnual report
「During the first three quarters of the current fiscal year, there were no new occurrences of the major risks that management recognises could materially affect the filing company's financial position, operating results or cash flows among the matters relating to business conditions, financial conditions and other matters described in the quarterly report, and no material changes to the "Business and Other Risks" described in the annual securities report for the previous fiscal year.」
The disclosure states that there have been no material changes in major risks, including those relating to the drug pricing system and approvals and licenses. - FY2024-Q2RestatedAnnual report
「In the pharmaceutical industry, measures to optimize medical costs, including pharmaceutical-system reforms and the further strengthening of policies to promote the use of generic drugs, continue to advance. As companies are required to further strengthen their management, the earnings environment is becoming increasingly challenging due to factors including higher R&D expenses and greater development risks.」
The Company continues to recognize that the earnings environment is challenging due to higher research and development expenses and increased development risks as drug pricing system reforms and measures to encourage the use of generic drugs continue. - FY2024-Q1RestatedAnnual report
「There were no new major risks during the three months ended 30 June, and no material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
The disclosure states that there have been no material changes in major risks, including those relating to the drug pricing system and approvals and licenses. - FY2023-Q3RestatedAnnual report
「During the first three quarters of the current fiscal year, there were no new occurrences of the major risks that management recognises could materially affect the filing company's financial position, operating results or cash flows among the matters relating to business conditions, financial conditions and other matters described in the quarterly report, and no material changes to the "Business and Other Risks" described in the annual securities report for the previous fiscal year.」
The disclosure states that there have been no material changes in major risks, including those relating to the drug pricing system and approvals and licenses. - FY2023-Q2RestatedAnnual report
「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including drug pricing system reforms and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses and increased development risks.」
The disclosure continues to describe the challenging earnings environment resulting from drug pricing system reforms, measures to encourage the use of generic drugs, and higher research and development expenses and development risks. - FY2023-Q1RestatedAnnual report
「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including drug pricing system reforms and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses and increased development risks.」
The Company continues to recognize that the earnings environment is challenging due to higher research and development expenses and increased development risks as drug pricing system reforms and measures to encourage the use of generic drugs continue. - FY2022The impact of legal violations and revocation of approvals and licenses has been specified.Annual report
「The pharmaceutical business is subject to various regulations under pharmaceutical administration. As part of measures to contain healthcare costs, policies have been adopted to reduce the prices of prescription drugs and encourage the use of generic drugs, and such healthcare policies may have a material impact on the Company's business performance. In addition, the pharmaceutical business operates subject to approvals and licenses from the relevant authorities and other bodies. The Company works to comply with relevant laws and regulations through regular training and the establishment of an internal reporting system. However, if approvals or licenses are revoked due to violations of laws or regulations, the Company's business performance may be materially affected by product recalls, the discontinuation of sales and other consequences.」
In addition to reductions in prescription drug prices and measures to encourage the use of generic drugs, the disclosure explicitly describes the impact of product recalls and discontinued sales resulting from legal violations or revocation of approvals and licenses, and identifies training and the internal reporting system as response measures. - FY2022-Q2RestatedAnnual report
「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including drug pricing system reforms and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」
The disclosure indicates that healthcare cost containment measures, including drug pricing system reforms and measures to encourage the use of generic drugs, continue and that the challenging earnings environment will persist. It states that there have been no material changes in business and other risks. - FY2021ReframedAnnual report
「The pharmaceutical business is subject to various regulations under pharmaceutical administration. As part of measures to contain healthcare costs, policies have been adopted to reduce the prices of prescription drugs and encourage the use of generic drugs, and such healthcare policies may have a material impact on the Company's business performance. In addition, the pharmaceutical business operates subject to approvals and licenses from the relevant authorities and other bodies.」
The previously stated risk from revisions to pharmaceutical regulations has been reorganized to include measures to contain healthcare costs, such as reductions in prescription drug prices and promotion of generic drug use, as well as the risk of losing approvals and licenses. - FY2021-Q3RestatedAnnual report
「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including drug pricing system reforms and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」
The disclosure continues to describe the challenging earnings environment resulting from higher research and development expenses, increased development risks and intensifying competition as drug pricing system reforms and strengthened measures to encourage the use of generic drugs continue. - FY2021-Q2RestatedAnnual report
「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including drug pricing system reforms and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」
The disclosure continues to describe the challenging earnings environment as drug pricing system reforms and measures to encourage the use of generic drugs continue. - FY2021-Q1RestatedAnnual report
「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including drug pricing system reforms and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」
The disclosure continues to describe the challenging earnings environment resulting from research and development expenses, development risks and intensifying competition as drug pricing system reforms and measures to encourage the use of generic drugs continue. - FY2020-Q3RestatedAnnual report
「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including drug pricing system reforms and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」
The Company continues to recognize that the earnings environment is challenging as drug pricing system reforms and strengthened measures to encourage the use of generic drugs continue to advance. It states that there have been no material changes in business and other risks. - FY2020-Q2RestatedAnnual report
「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including fundamental reform of the drug pricing system and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」
The Company continues to recognize that the earnings environment is challenging as drug pricing system reforms and strengthened measures to encourage the use of generic drugs continue to advance. It states that there have been no material changes in business and other risks. - FY2020-Q1RestatedAnnual report
「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including fundamental reform of the drug pricing system and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」
The disclosure indicates that drug pricing system reforms and strengthened measures to encourage the use of generic drugs continue to advance. It states that there have been no material changes in business and other risks. - FY2019RestatedAnnual report
「Various approval, licensing and monitoring systems are in place for pharmaceuticals and medical devices at each stage of development, manufacturing, importation, distribution and use by end users. Revisions to these systems and related regulations may affect business performance.」
The Company continues to identify revisions to pharmaceutical-related systems as a risk that may affect business performance. - FY2019-Q3RestatedAnnual report
「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including fundamental reform of the drug pricing system and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」
The Company continues to recognize that the earnings environment is challenging as drug pricing system reforms and strengthened measures to encourage the use of generic drugs continue to advance. It states that there have been no material changes in the risk that system revisions may affect business performance. - FY2019-Q2RestatedAnnual report
「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including fundamental reform of the drug pricing system and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」
The Company continues to recognize that the earnings environment is challenging as drug pricing system reforms and strengthened measures to encourage the use of generic drugs continue to advance. - FY2019-Q1RestatedAnnual report
「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including fundamental reform of the drug pricing system and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」
The Company continues to recognize that the earnings environment is challenging due to higher research and development expenses, increased development risks and intensifying competition, as drug pricing system reforms and strengthened measures to encourage the use of generic drugs continue to advance. - FY2018WorsenedAnnual report
「In the pharmaceutical industry, measures to contain healthcare costs have been promoted, including annual drug price revisions and fundamental reforms aimed at improving the quality of healthcare, in order to curb steadily rising social security costs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」
The disclosure states that the earnings environment is becoming increasingly challenging as annual drug price revisions and measures to contain healthcare costs progress. - FY2018-Q3WorsenedAnnual report
「In the pharmaceutical industry, based on the government's "Basic Policy for Fundamental Reform of the Drug Pricing System" published in December 2016, the main details of the reform were compiled in December 2017. Policies for fundamental reforms, including annual drug price revisions and improvements in the quality of healthcare, were presented, and measures to contain healthcare costs were promoted. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」
The disclosure specifies the main details based on the basic policy for fundamental reform of the drug pricing system and the policy of annual drug price revisions, and states that the earnings environment in the pharmaceutical industry is becoming increasingly challenging. - FY2018-Q1WorsenedAnnual report
「In the pharmaceutical industry, measures to contain healthcare costs have been promoted under the government's basic policy for fundamental reform of the drug pricing system published in December 2016, including a policy of revising drug prices annually. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」
The disclosure specifically describes the government's policy for fundamental reform of the drug pricing system and its policy of revising drug prices annually, and states that the earnings environment is becoming increasingly challenging. - FY2017RestatedAnnual report
「Various approval, licensing and monitoring systems are in place for pharmaceuticals and medical devices at each stage of development, manufacturing, importation, distribution and use by end users. Revisions to these systems and related regulations may affect business performance.」
The Company continues to identify revisions to pharmaceutical-related systems as a risk that may affect business performance. - FY2017-Q3RestatedAnnual report
「In the pharmaceutical industry, the environment surrounding healthcare continued to change rapidly, including ongoing discussions by the Council on Economic and Fiscal Policy regarding annual revisions to drug prices. As companies were required to further strengthen management in order to respond appropriately to changes in the market environment, the business environment remained challenging, with many issues to address, including higher research and development expenses, increased development risks and intensifying competition.」
The disclosure describes specific changes in the healthcare environment, including discussions regarding annual revisions to drug prices. Meanwhile, the business and other risks section states that there have been no material changes. - 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.」
The disclosure states that there have been no material changes to business and other risks, including the risk of revisions to pharmaceutical regulations, described in the previous fiscal year. - 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.」
The document states that there were no material changes to the business and other risks described in the previous fiscal year. - FY2016First statedAnnual report
「Various approval, licensing and monitoring systems are in place for pharmaceuticals and medical devices at each stage of development, manufacturing, importation, distribution and use by end users. Revisions to these systems and related regulations may affect business performance.」
The disclosure identifies as a risk the possibility that revisions to approval, licensing and monitoring systems may affect business performance.