OncoTherapy Science (4564) · RiskFirst stated

Legal and licensing risks in the clinical testing business

First written in FY2018. . Latest entry: FY2018.

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Regulatory and Licensing Compliance for In Vitro Diagnostic ProductsA theme 4 companies write about · 4 as a headwind · 0 as a tailwind

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Full recordFilings, disclosures and news, newest first

FY2018First statedAnnual report
「The clinical testing business conducted by our group, including large-scale cancer genetic analysis testing, requires the permission of the prefectural governor of the prefecture where the health and sanitation laboratory is located under the Act on Clinical Laboratory Technicians, or, where the laboratory is located in a city with a public health center or a special ward, the permission of the mayor of that city or the ward mayor.」
The company disclosed new risks related to regulatory approvals and regulations governing facilities and management structures in the clinical testing business, including large-scale cancer genetic analysis testing.

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