EMA Drug Approvals Monitor — EU / CHMP Approval & Opinion Change Feed

The change feed for EU drug regulation. Every scheduled run downloads the official EMA medicines register, diffs it against the previous run, and emits one record per regulatory event: a new marketing authorisation, a CHMP positive or negative opinion, a refusal, a withdrawal, a suspension. Other tools tell you a medicine's status now; this actor tells you what moved since you last checked — which is what a catalyst calendar, a competitive watch list and a market-access tracker actually need.

Covers the whole EU register: ~2,700 centrally authorised human and veterinary medicines, refreshed daily by EMA. No API key, no login, no scraping of third-party aggregators — only EMA's own published dataset.

This actor is EU-only by design. US FDA approvals are a separate, well-served market; here you get the EMA/CHMP side properly, with stable product ids and typed transitions.

Event types

eventType	What triggers it
new-authorisation	A medicine's status becomes Authorised — the EU marketing authorisation is granted.
chmp-opinion	The committee opinion becomes Positive or Negative (CHMP for human medicines, CVMP for veterinary) — typically 1–2 months ahead of the Commission decision.
withdrawal	Withdrawn, Application withdrawn, Revoked, Suspended, Lapsed, Expired, Withdrawn from rolling review, or removed from the register entirely.
status-change	Every other transition, including Refused and entry into Opinion / Opinion under re-examination. The catch-all, so nothing is silently dropped.

First run seeds — with a head start

By design the first run stores a baseline of the whole register, so you are never billed for 2,700 "changes" that are just the existing register. But the register carries EMA's own decision dates, so the seeding run also emits the recent history — every authorisation, refusal, withdrawal, suspension and opinion dated within sinceDays (default 30). You get immediate value on run one and pure deltas from run two on. Set sinceDays: 0 for a silent seed.

Recommended schedule: daily. EMA refreshes the dataset every morning (UTC); CHMP meets monthly, so opinion batches land in clusters.

Example output record

{
  "source": "ema-medicines",
  "productId": "EMEA/H/C/006629",
  "medicineName": "Hopledo",
  "inn": "levodopa;carbidopa",
  "marketingAuthHolder": "Zambon SpA",
  "category": "Human",
  "eventType": "new-authorisation",
  "oldStatus": null,
  "newStatus": "Authorised",
  "opinionOutcome": null,
  "therapeuticArea": ["Parkinson Disease"],
  "atcCode": "N04BA02",
  "decisionDate": "2026-08-20",
  "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hopledo",
  "detectedAt": "2026-08-31T09:44:55Z"
}

productId is the EMA product number (EMEA/H/C/… human, EMEA/V/C/… veterinary) — stable and unique for the life of the product, so it joins cleanly to your own pipeline. oldStatus is the status this actor last saw (null for a medicine new to the register or for a seed-run backfill record); newStatus is the current one. decisionDate is taken from the matching EMA date column — authorisation, refusal, withdrawal, suspension or opinion-adopted — and is null when EMA has not published one. opinionOutcome is populated on chmp-opinion records only. url is the medicine's EPAR page.

Input options

Field	Default	What it does
eventTypes	all four	Which kinds of event to emit. Pick chmp-opinion alone for a pure catalyst feed.
therapeuticAreas	all	Case-insensitive substring match on the medicine's MeSH therapeutic areas, e.g. Diabetes, Carcinoma, Non-Small-Cell Lung.
atcCodes	all	ATC / ATCvet prefix match, e.g. L01 (antineoplastics), A10 (diabetes), J07 (vaccines).
keywords	all	Substring match on medicine name, INN / active substance and marketing-authorisation holder, e.g. pembrolizumab, Novo Nordisk.
sinceDays	30	First-run backfill window in days (0–365). Ignored on later runs.
maxItems	500	Cap on event records per run. The baseline still updates in full.

Filters apply at emit time — the stored baseline always reflects the full register, so narrowing or widening a filter later never resurrects or duplicates old events.

Use cases

• Biotech / pharma catalyst trading — a CHMP positive or negative opinion is the tradeable EU event, and it lands weeks before the Commission decision. Filter to chmp-opinion plus your watch-list keywords and get the outcome the morning EMA publishes it.
• Competitive intelligence — watch a rival's marketingAuthHolder name or an ATC class and see every EU authorisation, refusal and withdrawal in your space without reading monthly meeting minutes.
• Market access & pricing — a new authorisation starts the national reimbursement clock in every member state. Feed authorisations straight into your launch tracker with the EPAR link attached.
• Pharmacovigilance & supply — suspensions, revocations and withdrawals are the events that pull a product from EU shelves; get them as records, not as a newsletter.

Reliability

• A failed download is a failed run, never a quiet day. If EMA's dataset is unreachable or stops looking like the expected {meta, data} envelope, the run aborts loudly with the baseline untouched — it never empties your state or reports the whole register as withdrawn.
• Exactly-once transitions. Each status or opinion move emits one record and never repeats, including a medicine that disappears from the register (emitted once as a withdrawal, then retained in state).
• No double-counting. The real Opinion → Authorised path moves two fields at once; you get one new-authorisation record, not two.
• Schema drift is logged, not fatal. Unparseable rows and dates are warned about and skipped; the rest of the run proceeds.

Pricing

Pay per event: a small per-run fee plus a fee per event detected. Quiet weeks cost almost nothing; CHMP weeks deliver exactly the records worth acting on.

Maintenance

The EMA dataset format is checked against the official publication; if EMA moves the download URL or renames a column, the actor is updated and the state format keeps your baseline. Output changes within a major version are additive only.

Changelog

• 0.1 — initial release: full EMA medicines register (human + veterinary), four typed event types, first-run date backfill, therapeutic-area / ATC / keyword filters.