National PV Systems — EU, USA, India, Japan, and UK

EudraVigilance is the EU’s central system for managing suspected adverse reaction data on medicines authorised or studied in the EEA, maintained by the EMA. MAHs submit ICSRs directly in E2B(R3) format; EVDAS provides signal detection using PRR and ROR disproportionality measures. From August 2025, EudraVigilance monitoring is a mandatory daily activity for all EU MAHs.

FAERS is the US spontaneous reporting database, receiving over 3 million reports annually. The Sentinel System is the FDA’s active surveillance infrastructure — a distributed network covering more than 100 million lives in US health insurance claims and EHR data. Sentinel NextGen integrates AI-based signal analytics and provides denominator (exposure) data spontaneous reporting alone cannot.

India’s PvPI network is detailed in Chapter 1 — 250+ AMCs coordinated by IPC under CDSCO, feeding VigiBase. India’s DPDP Act 2023 now governs how patient data in ICSRs is collected and stored, alongside GDPR (EU data) and HIPAA (US data) where applicable. Japan’s PMDA manages JADER, Japan’s FAERS equivalent, and the PMD Act requires designated post-marketing surveillance studies (DPMS) for newly approved products. The UK’s MHRA operates independently post-Brexit but aligned with EU GVP — the Yellow Card scheme dates to 1964, and products licensed in both the UK and EU require dual compliance, including separate PSMF arrangements.

For a company operating a single global product across all five regions, this means maintaining five parallel compliance tracks at once — one submission format and timeline for the EU, another active-surveillance obligation layered on top for the US, a separate India-specific data-residency requirement under the DPDP Act, a Japan-specific post-marketing study obligation, and a UK track that increasingly diverges from the EU it used to share a system with. No single "global" submission satisfies all five; each is a genuinely distinct regulatory relationship.