Never miss a PRAC recommendation, safety communication, or labeling change again. RegNexia AI monitors global safety regulators continuously so your PV team can act fast on what matters most.
50+
Safety authorities monitored
4
Continents of coverage
24/7
Continuous monitoring
AI
Powered summaries
Challenges
PRAC and safety committee updates are scattered and delayed
Automated monitoring of EMA PRAC, FDA Drug Safety Communications, and all major safety bodies surfaces updates within hours of publication.
Labeling changes require constant cross-market vigilance
Track SmPC, USPI, and regional labeling updates simultaneously across all markets where your products are approved.
Adverse event reporting requirements differ by jurisdiction
AI classifies each update by topic — including adverse event reporting, signal assessment, and REMS — so your team acts on the right information.
Signal assessment and benefit-risk documents are hard to track
Detect changes to PSURs, PASSes, risk management plans, and benefit-risk assessments the moment they are published or updated.
Capabilities
Monitor EMA Pharmacovigilance Risk Assessment Committee recommendations, safety referrals, and post-authorisation safety studies in real time.
Receive instant alerts for FDA Drug Safety Communications, DHPC letters, Dear Healthcare Provider letters, and urgent safety restrictions.
Detect amendments to SmPCs, USPIs, package inserts, and patient information leaflets across all monitored jurisdictions simultaneously.
Track changes to expedited reporting timelines, E2B submission formats, MedWatch requirements, and EudraVigilance reporting obligations.
Stay current on evolving RMP templates, additional risk minimisation measures, and post-marketing commitments from regulators globally.
Monitor WHO-UMC signal notifications, FDA Sentinel updates, and EMA signal assessment reports to stay ahead of emerging safety concerns.
Use Cases
Pharmacovigilance Director
Receives a prioritized daily safety regulatory digest covering PRAC outcomes, new safety referrals, and urgent labeling changes — across every market at once.
Signal Management Lead
Monitors WHO-UMC ICSRs and FDA Sentinel system updates to identify emerging signals before they escalate to regulatory action.
Safety Labeling Manager
Gets an alert the moment a competitor product's label is updated for a class-wide safety issue, enabling proactive label review for their own portfolio.
PSUR / Periodic Report Coordinator
Tracks EPAR updates, PSUR worksharing procedure outcomes, and PBRER submissions to align their reporting calendar with the latest regulator expectations.
Coverage
From PRAC sessions in Amsterdam to FDA safety communications in Washington, RegNexia captures every safety signal from every major authority.
Topics
Every update is auto-classified by PV topic so your team spends zero time sorting through irrelevant content.