Strengthening Global Regulatory Affairs and Clinical Development Functions
First written in FY2020. 6 of 11 entries say "Advanced", first in FY2022-Q1. Latest entry: FY2026.
0 other companies' latest entry also says "Advanced".
- FY2026AdvancedAnnual report
「In fiscal 2025, the company established the Global QARA Division to oversee quality assurance and regulatory governance across the group.」
In addition to its existing global regulatory approval framework, the company established an organization in fiscal 2025 to oversee quality assurance and regulatory governance across the group. - FY2026-H1AdvancedAnnual report
「June 2025: The company obtained marketing approval for the PrismGuideTMAPOE Genotype Test Kit, which determines APOE genotype from genomic DNA in blood and had been submitted for approval in September 2024. September 2025: The company's subsidiary 株式会社理研ジェネシス obtained marketing approval for the OncoGuide OncoScreen Plus CDx System. September 2025: The company's subsidiary Oxford Gene Technology obtained marketing authorization from the U.S. Food and Drug Administration (FDA) under the De Novo pathway for the CytoCell KMT2A Breakapart FISH Probe Kit PDx.」
As specific achievements in global regulatory and clinical development, the company obtained marketing approval in Japan for the APOE Genotype Test Kit and the OncoScreen Plus CDx System, and FDA De Novo authorization in the United States for the CytoCell KMT2A FISH Probe Kit. - FY2025-H1AdvancedAnnual report
「June 2024: 株式会社理研ジェネシス, our subsidiary, obtained domestic manufacturing and marketing approval for the in vitro diagnostic product OncoGuide™ EpiLight™ Methylation Detection Kit, jointly developed with Tohoku University Hospital, for use in assisting the selection of treatments for colorectal cancer.」
As a specific achievement in regulatory and clinical development functions, the company obtained marketing approval in Japan for the OncoGuide™ EpiLight™ methylation detection kit. - FY2024-Q2AdvancedAnnual report
「August 2023: The PrismGuide™ IRD Panel System, which provides information useful for identifying the causative genes of IRD by obtaining a comprehensive genomic profile from the blood of patients with or suspected of having inherited retinal dystrophy (IRD), and which received domestic manufacturing and marketing approval in May 2023, became the first IRD genetic panel testing system in Japan to receive reimbursement coverage.」
As a specific achievement in global regulatory and clinical development, the PrismGuide™ IRD Panel System obtained Japan's first health insurance coverage following its marketing approval. - FY2024-Q1AdvancedAnnual report
「The PrismGuide™ IRD Panel System obtained Japan's first marketing approval as an IRD genetic panel testing system.」
Regarding regulatory and clinical development functions, the company disclosed the specific approval achievement of obtaining Japan's first marketing approval for an IRD genetic panel testing system. - FY2023RestatedAnnual report
「Accordingly, the company seeks to keep abreast of the latest regulatory information by participating in industry associations in each country and through other means, while working to obtain and maintain regulatory approvals promptly and accurately through a global regulatory approval framework that leverages its network.」
The company has reiterated its efforts to gather regulatory information through industry associations and to obtain and maintain approvals promptly through its global regulatory approval framework. - FY2022Establishing a global framework for obtaining regulatory approvalsAnnual report
「Accordingly, the company seeks to keep abreast of the latest regulatory information by participating in industry associations in each country and through other means, while working to obtain and maintain regulatory approvals promptly and accurately through a global regulatory approval framework that leverages its network.」
In addition to its existing policy of strengthening a global product performance evaluation framework, the company describes gathering information from industry associations and establishing a regulatory approval framework that leverages its network. - FY2022-Q3RestatedAnnual report
「June 2021: The company obtained European In Vitro Diagnostic Medical Device Regulation (IVDR) certification for LYNOAMP™ CK19 E, a genetic amplification detection reagent based on the OSNA™ method.」
As part of its European regulatory compliance efforts, the company has reiterated its achievement in obtaining IVDR certification for LYNOAMP™ CK19 E. - FY2022-Q2RestatedAnnual report
「The Company obtained European In Vitro Diagnostic Medical Devices Regulation (IVDR) certification for LYNOAMP™ CK19 E, a gene amplification detection reagent based on the OSNA™ method.」
As part of its European regulatory compliance efforts, the company has reiterated its achievement in obtaining its first IVDR certification. - FY2022-Q1AdvancedAnnual report
「In the life sciences field, LYNOAMP™ CK19 E, a gene amplification detection reagent based on the OSNA™ method developed independently by the Company, obtained European In Vitro Diagnostic Medical Devices Regulation (IVDR) certification (Class C), the first such certification among the Company's products. The Company will continue activities to enhance the clinical value of cancer lymph node metastasis testing and pursue IVDR certification for its IVD products in each field supplied in Europe.」
Regarding European regulatory compliance, the company obtained its first IVDR Class C certification for LYNOAMP™ CK19 E and set out a specific policy of expanding certification to IVD products in each field offered in Europe. - FY2020First statedAnnual report
「To introduce new products to the market in a timely manner and capture business opportunities early, even amid increasingly stringent laws and regulations, the Company will work to strengthen its global product performance evaluation framework and take other measures.」
The company has separately identified the need to strengthen its regulatory and clinical development functions, including a global product performance evaluation framework, with the aim of bringing products to market earlier.