EUDRAVIGILANCE // AUTHORISED API + PUBLIC AGGREGATES

EudraVigilance API Workbench

Prototype for pharmacovigilance data work: authorised EudraVigilance/EVDAS-style API proxy calls when lawful credentials exist, direct API testing where permitted, and local analysis of public ADR aggregate tables.

Regulatory boundary: this app does not provide EudraVigilance credentials, does not bypass access controls and does not infer causality. Spontaneous reports are suspected adverse reactions, not incidence or proof of risk.

Supabase EV API proxy

The proxy is deployed as a Supabase Edge Function. It only becomes operational after configuring lawful EudraVigilance/EVDAS/API access details in Supabase secrets.

Proxy token

API path

Method

POST payload JSON

Required Supabase secrets: PV_PROXY_TOKEN, EV_API_BASE_URL and whichever authorised EV/API auth header/token is legally available.

Direct API test

For sandbox or institutionally authorised endpoints that allow browser CORS. Tokens stay in your browser and are not stored.

Full API URL

Bearer token

Public aggregate matrix

Paste CSV/TSV exported or copied from allowed public aggregate sources, such as adrreports.eu. Include columns for product/drug, reaction/event and cases/count for disproportionality.

Data

Drug/product

Reaction/event

Top events

Event	Cases

Breakdowns

Seriousness/category	Cases

Implementation map

This is the minimum serious architecture for a lawful version:

Layer	Standard/source	App implication
ICSR exchange	ICH E2B(R3), ISO ICSR	Use structured case fields; no arbitrary free-text-only model.
EU PV process	GVP Module VI, IX, XV, XVI	Separate ICSR processing, signal workflow, safety communication and RMMs.
EU data access	EudraVigilance Access Policy	Use only authorised data scope for each stakeholder group.
Spanish PV	AEMPS / SEFV-H / NotificaRAM	Respect national reporting pathway and public-health role.
Analytics	Disproportionality as screening	Display ROR/PRR as exploratory signal detection support only.