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HiroPharmaConsulting (R) Granted Patent for AI-enabled Reliability Assurance Method for Pharmacovigilance Systems

The Japan Patent Office granted a patent for the AI-PV HiroPharma Validation Method after the official registration on 21 November 2025, as HiroPharmaConsulting announced from Osaka.
Rising AI adoption in pharmacovigilance prompted HiroPharmaConsulting to develop the AI-PV HPVM, providing a structured method that meets GVP CSV requirements and addresses reliability gaps, the company says.
Enabling audit readiness, the AI-PV HPVM facilitates regulatory-compliant GVP CSV, supports continuous verification of AI functions, and enables demonstration of compliance to FDA, EMA, MHRA, NMPA, MFDS, MHLW, and PMDA.
HiroPharmaConsulting will offer paid and free licence agreements to AI-PV system manufacturers, Contract Research Organizations, and Marketing Authorization Holders, while unauthorised commercial use violates the Patent Act.
As a first-in-Japan patent, the development represents Japan's first IP for AI-enabled PV reliability, and following domestic allowance the company filed a PCT international application; Hirotsugu Atsumaru said it's "transformative" for pharma and technology companies.

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HiroPharmaConsulting (R) Granted Patent for AI-enabled Reliability Assurance Method for Pharmacovigilance Systems

OSAKA, Japan, Dec. 4, 2025 /PRNewswire/ -- HiroPharmaConsulting (R) Co., Ltd. announced that it has received a patent for an innovative Good Pharmacovigilance Practice (GVP) Computerized System Validation (CSV) methodology designed to ensure the reliability of pharmacovigilance systems equipped with…

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