Safety Navigator: Pharmacovigilance Guidelines by Country
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Description
Look up pharmacovigilance reporting requirements for 70+ countries: ICSR timelines, PSUR, RMP, QPPV and PSMF, with official links WHAT'S NEW IN 2.0 • Side panel dock: Safety Navigator beside your work so it stays open while you click around. The old popup closed the moment you clicked anything; now you can choose either, and your choice is remembered. • Copy button on every section as paste-ready text for an email, SOP or tracker, with the source link included. • 12 more countries added. • Corrections, plus a fix so your last selected country is restored correctly after an update. WHAT IT DOES Safety Navigator is a quick-reference for pharmacovigilance regulatory requirements across 70+ countries. Pick a country and see what that regulator expects; without digging through PDFs. • ICSR reporting timelines • Foreign vs. domestic case submission rules • PBRER / PSUR / PADER submission requirements • Risk Management Plan (RMP) requirements • Local QPPV requirements • Pharmacovigilance System Master File (PSMF) requirements • Direct links to the official source document for each country HOW IT WORKS Search by country or regulator, or pick from the dropdown. Switch between the ICSR, PSUR, RMP, QPPV and PSMF tabs. Click Copy in any section to take it with you, or follow the link straight to the regulator's own guidance. Open it as a popup for a quick look, or dock it in Chrome's side panel when you need it beside you while you work. PRIVACY No data collection, no tracking, no analytics, no external servers. All country data is bundled with the extension and read locally; the extension makes no network requests of its own. The only things stored are your last selected country and whether you prefer the popup or the side panel. Safety Navigator cannot read the pages you visit. It requests no host permissions and runs no content scripts. PLEASE NOTE This is a reference aid, not regulatory advice. Requirements change. Always verify against the regulator's current published guidance, linked for every country, before relying on it for a submission.