EMA Medicines Scraper — European Drug Authorisation Register

Extract the complete European Medicines Agency (EMA) centralised medicines authorisation register. Covers all human and veterinary medicines that have received, or applied for, a centralised EU marketing authorisation.

Data source: EMA nightly XLSX bulk export at ema.europa.eu. Updated every night by the EMA.

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What data does it extract?

Each record corresponds to one medicine and includes:

Field	Description
medicine_name	Brand name
category	Human or Veterinary
ema_product_number	EMA product number (e.g. EMEA/H/C/004781)
authorisation_status	Authorised, Withdrawn, Refused, or Suspended
opinion_status	CHMP/CVMP opinion status, where a decision is still pending
inn	International Non-proprietary Name / common name
active_substance	Active substance(s)
therapeutic_area	Therapeutic area (MeSH terms)
therapeutic_indication	Full authorised therapeutic indication text
atc_code	ATC code (human) or ATCvet code (veterinary), whichever is set
atcvet_code	ATCvet code (veterinary), kept separate for medicines that also carry a human ATC code
pharmacotherapeutic_group	Pharmacotherapeutic group
marketing_authorisation_holder	MAH company name
first_authorised_date	First EU marketing authorisation date (DD/MM/YYYY)
ec_decision_date	European Commission decision date (DD/MM/YYYY)
start_of_evaluation_date	Start of evaluation date (DD/MM/YYYY); rare
opinion_adopted_date	Date the CHMP/CVMP opinion was adopted (DD/MM/YYYY)
withdrawal_of_application_date	Date the application was withdrawn (DD/MM/YYYY); only on withdrawn applications
refusal_date	Date marketing authorisation was refused (DD/MM/YYYY); only on refused medicines
withdrawal_expiry_revocation_date	Date the authorisation was withdrawn, expired, revoked or lapsed (DD/MM/YYYY)
suspension_date	Date marketing authorisation was suspended (DD/MM/YYYY); rare
revision_number	EMA product information revision number
first_published_date	Date the medicine's EMA page was first published (DD/MM/YYYY)
last_updated_date	Date the medicine's EMA page was last updated (DD/MM/YYYY)
orphan_designation	Orphan medicine designation flag
biosimilar	Biosimilar flag
generic_or_hybrid	Generic or hybrid application flag
conditional_marketing_authorisation	Conditional approval flag
additional_monitoring	Additional monitoring (black triangle) flag
accelerated_assessment	Accelerated assessment flag
advanced_therapy	Advanced therapy medicinal product (ATMP) flag
prime_priority_medicine	PRIME (PRIority MEdicines) priority medicine flag
exceptional_circumstances	Exceptional circumstances flag
product_url	EMA product page URL

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Input options

Parameter	Type	Default	Description
medicineCategory	String	human	Filter: human, veterinary, or leave blank for all
authorisationStatus	String	Authorised	Filter: Authorised, Withdrawn, Refused, Suspended, or blank for all
therapeuticArea	String	(blank)	Filter by therapeutic area substring, case-insensitive (e.g. Diabetes)
atcCode	String	(blank)	Filter by ATC code prefix (e.g. L01 for antineoplastics)
authorisationDateFrom	String	(blank)	Include only medicines authorised on or after this date (YYYY-MM-DD or DD/MM/YYYY)
authorisationDateTo	String	(blank)	Include only medicines authorised on or before this date (YYYY-MM-DD or DD/MM/YYYY)
maxItems	Integer	15	Maximum number of records to return (0 = all)

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How it works

The actor downloads EMA's nightly XLSX bulk export (approximately 885 KB, ~2,700 records) using a single HTTP request. No browser automation, no pagination. The XLSX is parsed in-memory using Node.js built-in modules, then filtered and saved to the Apify dataset.

Performance: Typically completes in under 10 seconds.

Memory: 256 MB is sufficient. The actor is configured for 512 MB to be safe.

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Example run

Input:

{
  "medicineCategory": "human",
  "authorisationStatus": "Authorised",
  "atcCode": "L01",
  "maxItems": 5
}

Sample output record:

{
  "medicine_name": "Keytruda",
  "category": "Human",
  "ema_product_number": "EMEA/H/C/003820",
  "authorisation_status": "Authorised",
  "opinion_status": "",
  "inn": "pembrolizumab",
  "active_substance": "pembrolizumab",
  "therapeutic_area": "Melanoma; Carcinoma, Non-Small-Cell Lung; ...",
  "therapeutic_indication": "Keytruda as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults...",
  "atc_code": "L01FF02",
  "atcvet_code": "",
  "pharmacotherapeutic_group": "Antineoplastic agents, monoclonal antibodies",
  "marketing_authorisation_holder": "Merck Sharp & Dohme B.V.",
  "first_authorised_date": "17/07/2015",
  "ec_decision_date": "17/07/2015",
  "start_of_evaluation_date": "",
  "opinion_adopted_date": "28/05/2015",
  "withdrawal_of_application_date": "",
  "refusal_date": "",
  "withdrawal_expiry_revocation_date": "",
  "suspension_date": "",
  "revision_number": "45",
  "first_published_date": "21/07/2015",
  "last_updated_date": "12/09/2026",
  "orphan_designation": false,
  "biosimilar": false,
  "generic_or_hybrid": false,
  "conditional_marketing_authorisation": false,
  "additional_monitoring": true,
  "accelerated_assessment": false,
  "advanced_therapy": false,
  "prime_priority_medicine": false,
  "exceptional_circumstances": false,
  "product_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/keytruda"
}

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Use cases

• Pharma intelligence: Monitor which medicines have EU authorisation and track MAH portfolios
• Biotech business development: Identify orphan, biosimilar, or conditionally approved medicines
• Regulatory consulting: Track EU status of medicines by active substance or therapeutic area
• Academic research: Build datasets of authorised medicines by ATC code or indication
• Generics manufacturers: Identify authorised generic/hybrid medicines

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Notes

• Data is updated nightly by the EMA. Each actor run downloads the latest version.
• The dataset covers approximately 2,700 medicines in the centralised authorisation procedure. Nationally authorised medicines are not included.
• Withdrawn medicines remain in the dataset with status Withdrawn.