| Maven Safety completes FDA AS2 gateway integration to streamline global pharmacovigilance
| One-click ICH E2B(R3) submissions cut reporting time from hours to seconds
| Enhanced data security and traceability strengthen regulatory audit readiness
| Provides cost-efficient safety infrastructure supporting Korean biopharma’s global growth
JNPMEDI has finalized independent development of FDA AS2 gateway integration for its pharmacovigilance platform, Maven Safety—marking a significant step in strengthening the ability of Korean pharmaceutical and biotech companies to meet global regulatory requirements.
The company completed development and testing of the FDA Applicability Statement 2 (AS2) connection in September 2024, following an initial MFDS-focused project that began in late 2023. By shifting to FDA integration, JNPMEDI aligned Maven Safety with the most widely adopted global reporting standards and expanded its relevance for companies targeting the U.S. market.
The move comes as regulatory agencies including the FDA, EMA, and MFDS increasingly enforce compliance with the ICH E2B(R3) standard for safety reporting. Traditional manual submission processes—requiring separate extraction, login, and upload of each Individual Case Safety Report (ICSR)—have proven slow, resource-intensive, and vulnerable to human error. Maven Safety directly addresses these challenges by enabling one-click transmission of E2B(R3) ICSRs to the FDA through the AS2 gateway. Reporting cycles that previously took more than a full day now take only seconds, with immediate ACK/NACK confirmation streamlining operational workflows.
Beyond speed, the AS2-based system significantly reinforces the reliability and security of safety data. Automated validation reduces manual entry errors, while encryption, digital signatures, and MDN receipts ensure safe transfer of sensitive information. Built-in tracking and tamper-prevention features allow sponsors and CROs to maintain complete submission histories—an essential capability for regulatory inspections and long-term pharmacovigilance strategy.
Maven Safety also integrates natively with JNPMEDI’s clinical data management platform, Maven CDMS. This enables an end-to-end safety oversight framework that captures serious adverse events during clinical trials, validates data in real time, converts cases into E2B(R3) format, and submits them through the AS2 gateway without manual handling. For both sponsors and CROs, this provides a unified, traceable, and audit-ready infrastructure for global safety reporting.
Associate partner SeEun Kim noted that the FDA integration “allows Korean biopharma companies to manage complex reporting requirements internally, reduce dependency on external vendors, and accelerate development timelines for global markets.” She added that JNPMEDI will continue positioning Maven Safety as essential infrastructure supporting the global expansion of Korea’s innovative drug developers.
| Maven Safety completes FDA AS2 gateway integration to streamline global pharmacovigilance
| One-click ICH E2B(R3) submissions cut reporting time from hours to seconds
| Enhanced data security and traceability strengthen regulatory audit readiness
| Provides cost-efficient safety infrastructure supporting Korean biopharma’s global growth
JNPMEDI has finalized independent development of FDA AS2 gateway integration for its pharmacovigilance platform, Maven Safety—marking a significant step in strengthening the ability of Korean pharmaceutical and biotech companies to meet global regulatory requirements.
The company completed development and testing of the FDA Applicability Statement 2 (AS2) connection in September 2024, following an initial MFDS-focused project that began in late 2023. By shifting to FDA integration, JNPMEDI aligned Maven Safety with the most widely adopted global reporting standards and expanded its relevance for companies targeting the U.S. market.
The move comes as regulatory agencies including the FDA, EMA, and MFDS increasingly enforce compliance with the ICH E2B(R3) standard for safety reporting. Traditional manual submission processes—requiring separate extraction, login, and upload of each Individual Case Safety Report (ICSR)—have proven slow, resource-intensive, and vulnerable to human error. Maven Safety directly addresses these challenges by enabling one-click transmission of E2B(R3) ICSRs to the FDA through the AS2 gateway. Reporting cycles that previously took more than a full day now take only seconds, with immediate ACK/NACK confirmation streamlining operational workflows.
Beyond speed, the AS2-based system significantly reinforces the reliability and security of safety data. Automated validation reduces manual entry errors, while encryption, digital signatures, and MDN receipts ensure safe transfer of sensitive information. Built-in tracking and tamper-prevention features allow sponsors and CROs to maintain complete submission histories—an essential capability for regulatory inspections and long-term pharmacovigilance strategy.
Maven Safety also integrates natively with JNPMEDI’s clinical data management platform, Maven CDMS. This enables an end-to-end safety oversight framework that captures serious adverse events during clinical trials, validates data in real time, converts cases into E2B(R3) format, and submits them through the AS2 gateway without manual handling. For both sponsors and CROs, this provides a unified, traceable, and audit-ready infrastructure for global safety reporting.
Associate partner SeEun Kim noted that the FDA integration “allows Korean biopharma companies to manage complex reporting requirements internally, reduce dependency on external vendors, and accelerate development timelines for global markets.” She added that JNPMEDI will continue positioning Maven Safety as essential infrastructure supporting the global expansion of Korea’s innovative drug developers.