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Data Sources & Attributions

Last updated: October 11, 2026

Compliome's answers are grounded in public regulatory, legal, and biomedical data. We are grateful to the organisations below for making it openly available. Where a source requires attribution, a notice, or share-alike terms, we credit it here and preserve the applicable licence. Unless stated otherwise, we modify the material we ingest: we split it into sections or records, re-format it, link it to other sources, and index it for search; answers quote or summarise it.

No source listed on this page endorses, sponsors, or is affiliated with Compliome. Each source is credited only to identify where data comes from.

1. U.S. regulatory sources

Works of the U.S. Government, which are in the public domain in the United States:

  • Electronic Code of Federal Regulations (eCFR): Title 21 (Food and Drugs), 45 CFR Part 46 (protection of human subjects), and 42 CFR Part 11 (clinical-trial registration and results reporting). U.S. Government works, public domain. eCFR is an editorial compilation and is not an official legal edition of the CFR.
  • U.S. Food & Drug Administration (FDA): guidance documents, warning letters, the List of Cleared or Approved Companion Diagnostic Devices, REMS@FDA (Risk Evaluation and Mitigation Strategies), Drugs@FDA and the Orange Book. U.S. Government works, public domain.
  • openFDA: device 510(k)/PMA and classification data, recalls and enforcement reports, Drugs@FDA application records (products, marketing status, and the submission history of each application with its action-package documents), the NDC directory, substances (UNII, from FDA's Global Substance Registration System), and aggregate FAERS adverse-event counts. Public domain, CC0 1.0. FDA does not endorse Compliome.
  • DailyMed (U.S. National Library of Medicine): Structured Product Labeling for FDA drug labels. Public domain.
  • ClinicalTrials.gov (U.S. National Library of Medicine): trial registrations. Public domain.
  • RxNorm, RxNav and RxClass (U.S. National Library of Medicine): drug ingredient identities and drug-class links. This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • PubChem (National Center for Biotechnology Information): chemical structures and identifiers. Public domain.
  • openFDA (additional datasets): device recalls (with CDRH root causes), drug shortages, Complete Response Letters, and device establishment registration & listing. Public domain, CC0 1.0.
  • Federal Register (Office of the Federal Register, via the federalregister.gov API and GovInfo): FDA rules, proposed rules, and notices, with comment deadlines and dockets. U.S. Government works, public domain.
  • FDA Orphan Drug Designations and Approvals (OOPD) (Office of Orphan Products Development) and the FDA Table of Pharmacogenomic Biomarkers in Drug Labeling; the openFDA NDC Directory including delisted products (ndc_excluded). U.S. Government works, public domain. Orphan-indication disease matching uses the Mondo Disease Ontology (CC BY 4.0).
  • FDA Postmarketing Requirements and Commitments (downloadable database file, CDER and CBER): the studies and clinical trials FDA requires or applicants commit to after approval, with their legal basis, status and due dates. Because FDA's file keeps closed items for one year only, Compliome archives each quarterly release and keeps the last status it saw. U.S. Government works, public domain. Status shown is as reported in FDA's file on the snapshot date; FDA does not endorse Compliome.
  • FDA warning letters, 510(k) summaries and drug-label (DailyMed) text: retrieved from fda.gov, accessdata.fda.gov and DailyMed. U.S. Government works, public domain.
  • FDA Data Dashboard (Office of Inspections and Investigations, via the Data Dashboard API): inspection classifications (NAI/VAI/OAI) and the Form FDA 483 inspectional observations (citations) recorded for each inspection, fiscal year 2009 onward; compliance actions (warning letters, injunctions and seizures, fiscal year 2009 onward) and import refusals (refused import entry lines with product codes and refusal charges, fiscal year 2002 onward), for medical products only (drugs, biologics, medical devices and radiation-emitting products). U.S. Government works, public domain. As FDA notes, the Data Dashboard is a snapshot of FDA's internal systems at the time of publication, it does not include every inspection (or every Form 483 observation, compliance action or import refusal) FDA has conducted or issued, and its data are not a final agency determination of compliance. FDA does not endorse Compliome.
  • FDA Enforcement Report (internet Recall Enterprise System, iRES, via the Enforcement Report API): product recalls of all FDA centers with their recall events, classification, status and termination dates, and the recalling firm's FDA Establishment Identifier (FEI). U.S. Government works, public domain. Enforcement Report entries reflect FDA's classification of firm-initiated or FDA-requested recalls; inclusion is not a determination that a product violates the law, and FDA does not endorse Compliome.

2. European sources

  • European Medicines Agency (EMA): the European medicines data tables, including centrally authorised medicines and their lifecycle records: orphan designations, paediatric investigation plans (PIPs), referrals, periodic safety update single assessments (PSUSAs), direct healthcare professional communications (DHPCs), and medicine shortages; and, from the European public assessment reports (EPARs), the Annex II conditions of the marketing authorisation and the post-authorisation procedures, structured by Compliome with AI and each checked against the verbatim EPAR text it quotes. Source: European Medicines Agency. © European Medicines Agency; reproduced with acknowledgement of EMA as the source.
  • EU clinical trials: the Clinical Trials Information System (CTIS, euclinicaltrials.eu), run by the European Medicines Agency with the EU Member States and the European Commission, and the legacy EU Clinical Trials Register (EudraCT). Source: European Medicines Agency, CTIS and EU Clinical Trials Register. Reproduced with acknowledgement of the source.
  • EUR-Lex: EU legislation (regulations and directives), consolidated versions. © European Union, https://eur-lex.europa.eu. Reuse authorised with acknowledgement of source. Only the EU legislation published in the Official Journal of the European Union is authentic.
  • EU Guidelines for Good Manufacturing Practice (EudraLex Volume 4): the chapters, parts, annexes and glossary of the EU GMP guide published by the European Commission. Source: European Commission, health.ec.europa.eu, © European Union, reused under the Creative Commons Attribution 4.0 licence (CC BY 4.0, Commission Decision 2011/833/EU). Changes made: the text is extracted from the official PDFs, split into paragraphs and indexed for search. This is not an official version; the European Commission does not endorse Compliome.
  • EudraLex Volume 2 and Volume 10: the Notice to Applicants and regulatory guidelines for medicinal products for human use (Volume 2) and the guidance documents applying to clinical trials under Regulation (EU) No 536/2014 (Volume 10). Source: European Commission, health.ec.europa.eu. Commission documents: © European Union, reused under the Creative Commons Attribution 4.0 licence (CC BY 4.0, Commission Decision 2011/833/EU). Documents of the European Medicines Agency published in these volumes (GCP inspection procedures, quality guidelines for investigational medicinal products, the complex clinical trials Q&A, the centralised renewals guideline): © European Medicines Agency, reproduction authorised provided the source is acknowledged. Changes made: the text is extracted from the official PDFs, split into passages and indexed for search. This is not an official version and is not endorsed by the European Commission or EMA.

3. United Kingdom, Canada, Australia, and Switzerland

  • legislation.gov.uk: UK medicines and medical-devices legislation. Contains public sector information licensed under the Open Government Licence v3.0. Crown copyright.
  • UK MHRA / GOV.UK: MHRA regulatory guidance. Contains public sector information licensed under the Open Government Licence v3.0. Crown copyright.
  • Health Canada: the Drug Product Database (DPD). Contains information licensed under the Open Government Licence – Canada.
  • Justice Laws Website (Department of Justice Canada, laws-lois.justice.gc.ca): the Food and Drugs Act, the Food and Drug Regulations, and the Medical Devices Regulations. Reproduced under the Reproduction of Federal Law Order (SI/97-5). This is not an official version of these enactments and has not been produced in affiliation with, or with the endorsement of, the Government of Canada. For the official version, consult laws-lois.justice.gc.ca.
  • Federal Register of Legislation (Australia): the Therapeutic Goods Act 1989 and related therapeutic-goods legislation. Based on content from the Federal Register of Legislation at the date of our most recent retrieval (refreshed about every 30 days). For the latest information on Australian Government legislation please go to https://www.legislation.gov.au. Licensed under CC BY 4.0. Changes made: the compiled text is divided into individual provisions, re-formatted, and indexed for search.
  • Swissmedic (Switzerland): the list of authorised human medicines. Source: Swissmedic. © Swissmedic.

4. International harmonisation

  • ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use): the text of the ICH guidelines (official PDFs from database.ich.org, split into sections by Compliome), their Step status and dates, and the FDA guidances that adopt them. Source: ICH (ich.org). ICH guidelines are © ICH, used under ICH's public licence, which permits reuse with acknowledgement of ICH's copyright. Changes made: the official text is split into sections, re-formatted, and indexed for search; our sectioned copies are an adaptation of the original documents and are identified as such. For the official, unmodified guidelines, see ich.org. ICH does not endorse or sponsor Compliome, and nothing here implies that it does.

5. Biomedical & chemistry datasets

Open scientific datasets that enrich the knowledge graph (drug targets, chemistry, pathways, protein interactions, pharmacogenomics, and disease vocabularies). We reproduce each licence and its required attribution:

  • NCI Thesaurus (NCIt): the concept vocabulary behind Compliome's regulatory topics. The NCI Thesaurus™ is produced by the Enterprise Vocabulary Services group of the Center for Biomedical Informatics and Information Technology, National Cancer Institute, Maryland, USA. Licensed under CC BY 4.0. Modified: concepts are re-labelled, linked to regulatory text, and extended with topics we extract ourselves. "NCI Thesaurus" is a trademark of the National Cancer Institute.
  • DrugCentral: drug → target and ADME data. Data from DrugCentral (drugcentral.org), licensed CC BY-SA 4.0.
  • ChEMBL (EMBL-EBI): drug identifiers and mechanism-of-action data. Data from ChEMBL (ebi.ac.uk/chembl), licensed CC BY-SA 3.0.
  • ChEBI (EMBL-EBI): chemical entities of biological interest. ChEBI (ebi.ac.uk/chebi), CC BY 4.0.
  • UniProt: protein function and names. UniProt (uniprot.org), CC BY 4.0. Modified: selected fields only.
  • STRING: protein–protein interactions. STRING (string-db.org), CC BY 4.0. Modified: filtered to high-confidence interactions between targets in our graph.
  • Reactome: biological pathways. Reactome (reactome.org). Reactome data is dedicated to the public domain under CC0 1.0; we credit it as a courtesy.
  • Open Targets Platform: target–disease associations and drug indications. Open Targets (platform.opentargets.org), CC0 1.0.
  • Disease ontologies used for Open Targets disease identifiers: EFO, the Experimental Factor Ontology (EMBL-EBI, Apache License 2.0), and MONDO, the Mondo Disease Ontology (Monarch Initiative, CC BY 4.0).
  • Mondo Disease Ontology (Monarch Initiative, mondo.monarchinitiative.org) is also used directly to map clinical-trial conditions (MeSH) to diseases. Mondo Disease Ontology, CC BY 4.0; mappings derived by Compliome.
  • GLEIF Legal Entity Identifier data (gleif.org): legal names and parent relationships for organizations. Global Legal Entity Identifier Foundation, CC0 1.0.
  • CPIC (Clinical Pharmacogenetics Implementation Consortium): gene–drug pairs and guideline levels. CPIC data is dedicated to the public domain under CC0 1.0; credited as a courtesy to CPIC (cpicpgx.org) and ClinPGx (clinpgx.org).

Share-alike scope. The CC BY-SA share-alike terms apply only to the DrugCentral- and ChEMBL-derived data itself (and adaptations of that data); they do not extend to Compliome's software, other data, or the answers we generate. If you would like a copy of the DrugCentral- or ChEMBL-derived data as we hold it, contact us and we will provide it under the same licence.

6. Classification codes

Drug-class information (for example, Anatomical Therapeutic Chemical (ATC) codes, FDA Established Pharmacologic Classes, and mechanism-of-action classes) is retrieved through the NLM RxClass service (see the NLM statement above) and from regulators' own product records. The ATC classification system is maintained by the WHO Collaborating Centre for Drug Statistics Methodology. Its appearance here does not indicate any licence from, or endorsement by, the World Health Organization.

Licence texts: CC BY-SA 4.0, CC BY-SA 3.0, CC BY 4.0, CC0 1.0, Apache 2.0, OGL v3.0, OGL – Canada, Reproduction of Federal Law Order.

7. Accuracy & corrections

These sources are aggregated automatically and may lag their originals. None of the legal texts reproduced here is an official version; always confirm against the primary source for regulatory decisions. If you believe a source is mis-attributed or a licence is stated incorrectly, please tell us at contact@levacells.com and we will correct it.