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 AI functions. This patent represents Japan's first intellectual property specifically dedicated to the reliability assurance of AI-enabled pharmacovigilance systems. The Japan Patent Office has officially recognized the invention's novelty and inventive step, underscoring its significance as a breakthrough in regulatory-compliant AI system validation.

Details
-Patent Number: Japan Patent No. 7778327
-Title: Validation System and Method Compliant with Proper Standards Incorporating AI Functions
-Grant date: 21 November 2025

Addressing Reliability Challenge in AI-Enabled Pharmacovigilance
The patented technology, known as the AI-PV HiroPharma Validation Method (AI-PV HPVM), provides a structured and rational methodology to ensure the reliability and regulatory compliance of AI-enabled PV systems. As the pharmaceutical and medical device industries increasingly adopt AI to enhance pharmacovigilance, ensuring the accuracy, consistency, and auditability of these systems has become paramount. The AI-PV HPVM addresses this need by enabling:

-Rational and Compliant GVP CSV: Facilitates the implementation, documentation, and maintenance of GVP CSV, a critical regulatory requirement for patient safety.

-Audit Readiness: Prepares organizations for regulatory audits by providing comprehensive documentation and verifiable evidence of system validation.

-Continuous Verification: Supports ongoing monitoring and documentation of AI functionality--including automatic learning, capability sustainability, and performance enhancement--throughout both the feasibility study (FS) and operational phases.

-Global Regulatory Compliance: Enables clear, consistent demonstration of GVP compliance for major regulatory authorities worldwide, including the FDA (U.S.), EMA (EU), MHRA (U.K.), NMPA (China), MFDS (South Korea), MHLW (Japan), and PMDA (Japan).

Following the domestic Japan patent allowance, the company has now filed a PCT international application to expand global protection. This step strengthens the patent's global enforceability and enables future collaboration with pharma and technology companies worldwide.

"This patent underscores HiroPharmaConsulting's commitment to advancing innovation in pharmacovigilance and to ensuring patient safety through reliable and compliant AI-enabled PV system validation methods," said Hirotsugu Atsumaru, CEO of HiroPharmaConsulting (R).

Availability
Following the official patent registration on 21 November 2025, HiroPharmaConsulting (R) has launched the AI-PV Validation Service based on the AI-PV HPVM. The company will provide both paid and free license agreements to AI-PV system manufacturers in Japan and internationally, Contract Research Organizations (CROs), and major Marketing Authorization Holders (MAHs).