Risks from Amendments to and Strengthening of Laws and Regulations, and the Revocation of Licenses and Permits
First written in FY2021. 3 of 5 entries say "Restated". Latest entry: FY2026.
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- FY2026MitigatedAnnual report
「The manufacturing license for specified cell-processed products is essential to the continuation of the company's principal business activities, and no grounds for revocation had arisen as of the filing date of this document.」
The manufacturing licenses for specified cell-processed products in Tokyo and Yokohama were renewed and maintained with validity periods through 2031, respectively, and no grounds for revocation had arisen as of the filing date. The regulatory risk itself continues. - FY2025RestatedAnnual report
「As countermeasures, the company monitors information from relevant government authorities and academic societies and conducts company-wide internal audits, ISO 9001 internal audits covering the Cell Technology Division, and internal audits related to the PrivacyMark system, thereby regularly verifying compliance with legal and regulatory requirements.」
The company continues to address the risks related to amendments to or tightening of laws and regulations, non-compliance, and revocation of the manufacturing license for specified cell-processed products through internal audits and other measures. - FY2023RestatedAnnual report
「As countermeasures, the company monitors information from relevant government authorities and academic societies and conducts company-wide internal audits, ISO 9001 internal audits covering the Cell Technology Division, and internal audits related to the PrivacyMark system, thereby regularly verifying compliance with legal and regulatory requirements.」
The company continues to address the risks of amendments to or tightening of laws and regulations and revocation of permits and licenses by gathering information from relevant government authorities and academic societies and conducting various internal audits. - FY2022RestatedAnnual report
「The manufacturing license for specified cell-processed products is essential to the continuation of the company's principal business activities, and no grounds for revocation had arisen as of the filing date of this document. However, if the license were revoked or otherwise lost in the future, the company's principal business activities could be disrupted.」
The company continues to disclose the risk of amendments to or tightening of laws and regulations and revocation of permits and licenses, and identifies compliance checks through ISO 9001 internal audits, AABB inspections and company-wide internal audits as countermeasures. - FY2021First statedAnnual report
「However, if these laws and regulations are amended or tightened, new laws or regulations are enacted, or the company fails to comply with them, additional measures or other restrictions on the business may arise and affect the company's business and performance.」
Compliance with laws, regulations and standards is verified through ISO 9001 internal audits, AABB inspections and company-wide internal audits. The validity period of the manufacturing license for specified cell-processed products is also disclosed.