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AI-Powered Regulatory Intelligence Platform

Every update from global and local regulatory authorities in one feed — with AI summaries instead of manual website checks.

53+ Countries 1 Day to Add a Market Same-Day Support

DrugCard monitors regulatory authority websites continuously and collects every update they publish — not only the ones you knew to look for. AI writes a summary of each publication, and the platform files it by authority, country and topic, so your team stops checking dozens of sites by hand.

Why Regulatory Intelligence Is Difficult to Manage Manually

Regulatory intelligence rarely fails for lack of effort. It fails because the information is scattered, unstructured, and never stops arriving.

Manual Regulatory Monitoring

Each authority publishes on its own website, in its own format and language. Local sources are harder still. Email alerts arrive unsorted, most of them irrelevant — and it all ends up in an Excel tracker that one person maintains by hand and nobody else fully trusts.

Regulatory Intelligence with DrugCard

Everything lands in one centralised environment. AI writes a plain-English summary of each publication, and the feed is organised by authority, country and type of update. Email notifications arrive at the frequency you choose, and an action log records what was searched, opened and reviewed.

What Is Regulatory Intelligence?

Regulatory intelligence is the systematic monitoring of regulatory updates, requirements, changes and publications issued by health authorities. It matters because those publications set how a pharmacovigilance quality management system has to operate, what has to be reported and when, and which legal obligations a marketing authorisation holder carries in each market.

A pharmaceutical regulatory intelligence tool supports four things: awareness of what changed, assessment of what it affects, implementation in SOPs and processes, and evidence of compliance for inspectors.

What Regulatory Updates Can You Monitor?

All updates published on a source website land in DrugCard, whatever the topic. You choose which authorities to follow in your settings, then filter the feed by topic, country or keyword to reach what your team owns.
Topic chips: Pharmacovigilance · Marketing authorisation · Variations and lifecycle · Dossier / eCTD · Labelling and packaging · Clinical trials · Quality and manufacturing · Inspections and compliance

For pharmacovigilance teams, seven of those groups carry most of the work:

Drug Safety Reporting Requirements

Changes to expedited and periodic reporting timelines, submission channels and country-specific rules for ICSR submission.

Pharmacovigilance Guidelines and Guidance

New and revised GVP modules, national guidance documents and authority Q&As that reset how a PV system is expected to work.

ICSR Requirements

Updates to E2B versions, validation rules, gateway configurations and the technical formats each market accepts.

Signal Management Requirements

Changes to signal detection, validation and documentation expectations that feed directly into your signal management services.

PSUR & PBRER Requirements

Revised data lock points, submission formats and frequencies, and assessment procedures affecting aggregate reporting schedules and PSUR services.

Risk Management Requirements

RMP template revisions, additional risk minimisation measures and effectiveness-reporting expectations from the EMA, MHRA and national authorities.

QPPV & Local Pharmacovigilance Requirements

Local QPPV and LCPPV appointment rules, PSMF requirements, registration duties and national qualification criteria across your markets.

How DrugCard Supports Regulatory Intelligence

The regulatory intelligence solution handles three steps that would otherwise eat a specialist's week: collection, summarisation and delivery.

Monitor Global and Local Regulatory Authorities

DrugCard tracks regulatory authorities across 53+ countries, from the EMA and FDA down to national bodies whose publications never reach an English-language regulatory intelligence database. New items are picked up the day they appear.

AI Summarises Every Publication

Each publication gets an AI-generated summary, so screening a 40-page guidance for relevance becomes reading three sentences. The authority, country and document type come from the source itself — not from a model guessing.

Deliver Updates to Your Team

Notifications go by email to the address set in your profile, at a frequency you control rather than the fixed weekly cycle most services impose.

Key Features of Our Regulatory Intelligence Platform

Six capabilities cover the working cycle: from an authority publishing something to your team being able to prove it acted.

Global & Local Regulatory Monitoring

Follow every authority in your markets from one workspace, with a new country switched on within a day.

AI Summaries

Read an AI-written summary before deciding whether the full document needs a proper review.

Advanced Search & Filtering

One cross-site search across differently structured authority websites, with filters by country, topic and keyword.

Custom Regulatory Alerts

Set your own update frequency instead of a fixed weekly digest, and save key publications to Favorites.

Regulatory Update History & Documentation

An action log records what was searched, opened and reviewed — inspection evidence without a separate tracker.

API & Platform Integrations

Native links to other DrugCard modules, plus API access to push updates into your own compliance systems.

See a Regulatory Update Inside DrugCard

A single update view carries the original document, its AI summary, the issuing authority, the country and the publication date. From there you can save it to Favorites or export it with your notes for an impact assessment.