EMA Medicine Status Records — EU Medicines

Official source. No API key. Pay per record.

This actor turns the European Medicines Agency's official medicines report into clean, per-medicine records — the regulatory status of every centrally-authorized EU medicine (and the ones refused, withdrawn, suspended, or revoked). Each run reads EMA's published medicines-output spreadsheet and delivers one row per medicine: the name and EMA product number, the status, the marketing-authorisation holder, the therapeutic and classification detail, and the full set of regulatory dates — authorisation, refusal, withdrawal, suspension. Product and organization grain, EMA-licensed for commercial reuse, no person fields.

What this is, in one paragraph

EMA publishes the complete list of medicines it has assessed as a downloadable report — every human and veterinary medicine with its current regulatory status and history. This actor reads that official spreadsheet directly, streams it row by row, and flattens each medicine into a single analysis-ready record: what it is, who holds the marketing authorisation, its therapeutic area and ATC code, the regulatory flags (orphan, biosimilar, generic, conditional, PRIME), and every status date on file. Values are verbatim. You are billed only for records actually delivered.

Who buys this and for what job

• Pharma regulatory and market-access teams tracking EU medicine status — new authorisations, refusals, withdrawals, suspensions — across their own and competitors' portfolios.
• Competitive-intelligence and market analysts mapping which companies hold authorisations in a therapeutic area, and watching status changes.
• Health-tech and data products ingesting a structured EU medicines register keyed by EMA product number and INN.
• Data engineers who want a keyless, one-call EU medicines-status feed already reduced to product/org fields.

Licence — commercial reuse permitted, with acknowledgement

EMA is explicit: "Information and documents made available on EMA's webpages are public and may be reproduced and/or distributed, totally or in part ... for non-commercial and commercial purposes provided that EMA is always acknowledged as the source of the material." Every record carries the required attribution: "Source: European Medicines Agency (EMA)." EMA notes that third-party content is excepted; this actor carries EMA's own tabular medicine-status data, not third-party documents. These are metadata records for status-tracking, not medical or regulatory advice.

Product / organization grain — no person data

This actor works at product and organization grain: the medicine and its marketing-authorisation holder (a company). The EMA medicines report carries no natural-person fields — the only party field is the authorisation-holder organisation — and this actor emits none, with a person-key guard on every record as a backstop.

Pricing

Event	Free plan	Bronze	Silver	Gold / Platinum / Diamond
medicine_status_record	$0.05	$0.045	$0.04	$0.0335

Delivered before charged. Blocked runs and empty results cost nothing.

Input

Field	Type	Default	Description
category	select	All	Optional. Keep only Human or Veterinary medicines.
statusFilter	string	—	Optional. Keep only medicines whose status contains this text (e.g. Authorised, Withdrawn, Refused). Applied to delivered records.
maxRecords	integer	500	Ceiling on records delivered and billed.

Output

One JSON object per medicine. Example (values verbatim):

{
  "record_id": "EMEA/H/C/005243",
  "category": "Human",
  "name_of_medicine": "Lacosamide UCB",
  "ema_product_number": "EMEA/H/C/005243",
  "medicine_status": "Authorised",
  "inn_common_name": "lacosamide",
  "active_substance": "lacosamide",
  "therapeutic_area": "Epilepsies, Partial",
  "atc_code_human": "N03AX18",
  "orphan_medicine": "No",
  "marketing_authorisation_holder": "UCB Pharma S.A.",
  "european_commission_decision_date": "2024-12-20",
  "marketing_authorisation_date": "2024-12-22",
  "refusal_date": null,
  "revision_number": "3",
  "last_updated_date": "2026-08-01",
  "source": "European Medicines Agency (medicines-output report)",
  "source_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lacosamide-ucb",
  "licence": "European Medicines Agency (EMA) ... commercial purposes provided that EMA is always acknowledged ...",
  "attribution": "Source: European Medicines Agency (EMA).",
  "observed_at": "2026-08-19T00:00:00Z"
}

An unbilled RUN_RECEIPT records the robots check, the filters, medicines seen and delivered, and whether charged equals delivered.

Field reference

Each record is a flat set of medicine-status fields. Identity: record_id / ema_product_number, name_of_medicine, and category (Human/Veterinary). Status: medicine_status and opinion_status. Substance and classification: inn_common_name, active_substance, therapeutic_area, atc_code_human, atcvet_code, pharmacotherapeutic_group_human, and therapeutic_indication. Regulatory flags: accelerated_assessment, additional_monitoring, advanced_therapy, biosimilar, conditional_approval, exceptional_circumstances, generic, orphan_medicine, and prime_priority_medicine. Who holds it: marketing_authorisation_holder — an organisation. The dates: ec_decision_date, start_of_evaluation_date, opinion_adopted_date, withdrawal_of_application_date, marketing_authorisation_date, refusal_date, withdrawal_expiry_revocation_date, and suspension_date, plus revision_number, first_published_date, and last_updated_date. Provenance: source, source_url, licence, attribution, disclaimer, and observed_at.

How a run works

A run first re-reads EMA's robots policy from your runtime and confirms the medicines report path is allowed (EMA's robots file permits it; the run stops at the door only if that changes). It then downloads the official medicines-output spreadsheet and streams it row by row — locating the header row by matching EMA's own column names, so a cosmetic layout shift doesn't break it. Each medicine is flattened to one record, dates normalized to ISO strings and blanks to null, and delivered before it is charged, so a blocked or empty run costs you nothing. Your optional category and status filters are applied per record before delivery, so you are billed only for medicines that pass them. The actor stops at your maxRecords ceiling, and the receipt's charge_equals_delivered flag confirms you were billed for exactly what you received.

Status categories you can track

The medicine_status field is the heart of this feed, and it captures the full regulatory lifecycle: Authorised (currently on the EU market), Refused (a marketing authorisation the Commission declined), Withdrawn (the holder pulled the application or the authorisation), Suspended, and Revoked/Expired/Lapsed. Because each status also has its own dated column — marketing_authorisation_date, refusal_date, withdrawal_expiry_revocation_date, suspension_date — you get not just the current state but when each transition happened, which is what makes this a genuine status-change feed rather than a static register. Filter to just refusals or withdrawals with statusFilter to build a focused negative-signal watchlist, or pull the whole set and diff on last_updated_date between runs to catch every medicine whose status EMA touched since you last looked.

Cost guidance

One medicine_status_record per delivered medicine: cost = medicines delivered × your plan's per-record price. The full EMA medicines report holds about 2,730 medicines, so a complete pull is roughly $137 (Free) / $91 (Gold). Scope with category or statusFilter (e.g. only withdrawn or refused medicines) to keep runs smaller and cheaper.

Honest limitations

• Metadata / status grain. This is the medicine's regulatory-status record — not the full assessment report or product label text.
• Centrally-published EMA report. It reflects the medicines in EMA's official output spreadsheet; nationally-authorised-only medicines are outside this file.
• Dates are as published by EMA (normalized to ISO YYYY-MM-DD); blank date fields are delivered as null.
• Point-in-time. Statuses and dates change; re-run to refresh, and diff by last_updated_date to catch changes.
• No person data is emitted.

Differentiation

Distinct from the FDA cells in this fleet — fda-device-clearance-records and fda-recall-risk-records — which are a different agency (US FDA) and different product events. This is the EU medicines register from EMA. There is no other EMA-sourced product in the NexGenData fleets, so this actor does not overlap any internal sibling — it opens EU medicine-status coverage that the fleet did not previously carry.

The NexGen Signal family

Part of the NexGen Signal family of official-source, pay-per-record products:

• Drug Label Change Records — NLM DailyMed
• FDA Device Clearance Records — 510(k)
• FDA Recall Risk Records — openFDA
• EU Regulatory Change Records — EUR-Lex
• World Bank Project Records — Development Pipeline

Source: European Medicines Agency (EMA) medicines-output report. EMA information may be reproduced for commercial and non-commercial purposes provided EMA is acknowledged as the source; third-party content excepted. Reformatted to product/org records; values verbatim; no person data emitted.