Risks Associated with Changes to and Revocation of Laws, Regulations, Permits and Approvals Related to Regenerative Medicine
First written in FY2019. 4 of 5 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
「The license to manufacture specified cell-processed products is essential to the continuation of our principal business activities. Article 49 of the Act on Ensuring Safety of Regenerative Medicine specifies the grounds for revocation of the license, including when the structure or equipment of the cell culture processing facility covered by the license no longer conforms to the standards prescribed by the Ministry of Health, Labour and Welfare, when any of the grounds for refusal of a license under the items of Article 35, paragraph 4 of the Act on Ensuring Safety of Regenerative Medicine applies, or when laws and regulations, including the Act on Ensuring Safety of Regenerative Medicine, are violated. None of these grounds for revocation had arisen as of the date of submission of this document. However, if the license is revoked or otherwise becomes unavailable in the future, our business activities could be significantly affected, including by making it necessary to suspend our services.」
The validity periods and grounds for revocation of various licenses and registrations, including the license to manufacture specified cell-processed products, were disclosed in detail. No grounds for revocation had arisen as of the submission date, but the risk of service suspension following future revocation remains. - FY2022RestatedAnnual report
「If the company were subject to administrative action, such as revocation of permits or registrations, on the grounds that it had violated these laws or regulations, if it were subject to administrative sanctions such as suspension of operations or surcharge payments, or if it incurred liability for damages under the Product Liability Act or other laws」
Risks relating to regenerative medicine regulations, revocation of permits and approvals, suspension of operations, surcharge payments and damages liability continue. - FY2021RestatedAnnual report
「If the company were subject to administrative action, such as revocation of permits or registrations, on the grounds that it had violated these laws or regulations, if it were subject to administrative sanctions such as suspension of operations or surcharge payments, or if it incurred liability for damages under the Product Liability Act or other laws」
Risks relating to regenerative medicine regulations, revocation of permits and approvals, suspension of operations, surcharge payments and damages liability continue. - FY2020RestatedAnnual report
「If the company were subject to administrative action, such as revocation of permits or registrations, on the grounds that it had violated these laws or regulations, if it were subject to administrative sanctions such as suspension of operations or surcharge payments, or if it incurred liability for damages under the Product Liability Act or other laws」
Risks relating to regenerative medicine regulations, revocation of permits and approvals, suspension of operations and surcharge payments continue. - FY2019First statedAnnual report
「If the company were subject to administrative action, such as revocation of permits or registrations, on the grounds that it had violated these laws or regulations, or if its operating results and financial condition were affected by a loss of confidence in the company arising from such an event, this could have an impact.」
The company identifies violations of the Act on the Safety of Regenerative Medicine and the Pharmaceuticals and Medical Devices Act, changes to the regulatory framework, and revocation of permits and approvals as risks.