EMA Drug Approval Watch — Daily Monitor for Pharma CI & Market Access

Daily delta monitoring of EMA new drug approvals, CHMP opinions, indication updates and withdrawals — for Pharma Competitive Intelligence, Business Development, and Market Access teams.

Built on the official EMA EPAR dataset. Pushes a structured alert per new or changed authorisation. Optional webhook delivers each alert to Slack, Teams, your data pipeline, or any HTTPS endpoint within seconds.

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What this Actor does

This Actor watches the European Medicines Agency's official EPAR dataset on a schedule you control. On each run it:

1. Downloads the canonical xlsx export of all centrally-authorised medicines.
2. Computes a stable identity for each product (product number + auth date + status) and diffs against the seen-set in its KV store.
3. Pushes only the new or changed records to the dataset — never duplicates.
4. Optionally fires a HMAC-signed webhook for every new alert.
5. Charges the buyer once per calendar month for the subscription, plus per pushed alert.

Run it on an Apify Schedule (daily/hourly/weekly — your choice). First run rebuilds the baseline; subsequent runs deliver only the delta.

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Use Cases — $-impact framing

1. Pharma Competitive Intelligence — react within hours of an EMA approval

A pharma CI analyst monitors approvals in their indication area (e.g. NSCLC). The day a competitor's drug gets EMA marketing authorisation, the alert lands in their Slack channel with active substance, MAH, indication, and EPAR link. Time-to-insight: minutes vs. weeks of manual EMA portal trawling.

2. Market Access — early signal for AMNOG / NICE / HAS prep

A German market-access lead filters therapeuticAreaFilter: ["Oncology"] and pipes alerts into their internal AMNOG-prep tracker. New oncology approvals are auto-routed to the dossier owner with the EPAR pre-populated. Saves 4-6 weeks of preparation time per submission, the difference between hitting and missing an early reimbursement window.

3. BD scouting — never miss a license-in opportunity

A biotech BD team monitors withdrawals + indication-changes on small-MAH products as proxies for divestment / partnering signals. A weekly digest highlights products from MAHs <€100M revenue that just received negative CHMP opinions or partial withdrawals — early-stage license-in candidates before they hit the broker market.

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Output

Each dataset item conforms to the unified RegulatorAlert schema shared across this publisher's Tier-A monitoring actors (FDA Watch, Swissmedic+MHRA+HC, BfArM/PEI, …). Buyers subscribed to multiple regulators get identical column structure for trivial UNION ALL.

Example item

{
  "scrapedAt": "2026-05-06T07:30:00.000Z",
  "sourceUrl": "https://www.ema.europa.eu/en/medicines/human/EPAR/keytruda",
  "sourceDomain": "ema.europa.eu",
  "actorVersion": "1.0.0",
  "dataHash": "9c1f...e5",

  "regulator": "EMA",
  "alertType": "approval-update",
  "recordId": "EMEA/H/C/003820",
  "changeKind": "new",

  "productName": "Keytruda",
  "activeSubstance": "pembrolizumab",
  "inn": "pembrolizumab",
  "atcCode": "L01FF02",
  "manufacturer": "Merck Sharp & Dohme B.V.",
  "therapeuticArea": "Carcinoma, Non-Small-Cell Lung",
  "indication": "Pembrolizumab as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma in adults whose tumours...",

  "publishedAt": "2026-05-05",
  "effectiveAt": "2026-05-05",
  "severity": null,
  "summary": "Keytruda: New indication added — adjuvant treatment of high-risk NSCLC after surgery.",
  "rawSnippet": null,

  "documents": [
    { "kind": "EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/keytruda", "title": "Keytruda" }
  ],
  "extras": { "status": "Authorised", "orphan": false }
}

Webhook payload

If you set webhookUrl, every new alert is also POSTed:

{
  "eventId": "9c1f...e5",
  "eventType": "ema.approval-update",
  "actor": "ema-drug-approval-watch",
  "emittedAt": "2026-05-06T07:30:01.123Z",
  "schemaVersion": 1,
  "data": { /* the alert object above */ }
}

The header X-Azureblue-Signature: sha256=<hex> is included if you set webhookSecret — verify it server-side with HMAC-SHA256 over the raw body.

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Pricing

Two-tier PAY_PER_EVENT model:

Event	Charge	When it fires
Monthly subscription	$79	Once per calendar month per user, on first delta-mode run
Per alert	$0.02	Per new/changed record pushed to the dataset

A typical pharma CI buyer running this daily on EU oncology approvals sees ~15-30 alerts/month: $79 + ~$0.30/mo ≈ $80/mo all-in. Compare to ~4 hours/week of manual EMA portal monitoring at €100/h fully-loaded.

Trial mode (mode: "trial") returns 5 results, no charges, no state writes — perfect for evaluating before subscribing.

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Compliance

• Public-data only — sources from the EMA's official EPAR dataset (https://www.ema.europa.eu) which is published under EU re-use terms.
• No PHI, no patient data — the EPAR is a list of authorised medicines, not patient records.
• GDPR Art. 6(1)(f) basis — legitimate-interest scraping of public regulatory data. The buyer is responsible for their downstream use of the data.
• Audit log — every fetch is recorded in the actor's KV store (URL + timestamp, no PII) so you can prove compliance to internal audit.

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Sister Actors — same publisher, complementary coverage

• ema-drug-approval-scraper — full EPAR snapshot + filters (sister: lookup, no monitoring)
• fda-drug-approval-watch — same alert schema, FDA Drugs@FDA + recalls + warning letters
• bfarm-pei-pharmacovigilance-monitor — German PV alerts (Rote-Hand-Briefe, BfArM Risikoinformationen, PEI Sicherheitsmeldungen)
• clinical-trials-scraper — ClinicalTrials.gov lookup
• ctis-watch — EU Clinical Trials Information System monitor

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Changelog

See CHANGELOG.md.