MedDRA
MedDRA, the Medical Dictionary for Regulatory Activities, is an ICH standardized medical terminology used internationally for registration, documentation, safety monitoring, and pharmacovigilance of medical products.
[{"category": "Organization", "contact_details": [{"contact_type": "url", "value": "https://admin.ich.org/page/meddra"}], "label": "ICH MedDRA Maintenance and Support Services Organisation"}]
[{"category": "Product", "description": "MedDRA terminology release files maintained and distributed by the MedDRA MSSO for subscribers, supporting regulatory coding and pharmacovigilance workflows.", "id": "meddra.release-files", "name": "MedDRA Terminology Release Files", "original_source": [{"relation_type": "prov:hadPrimarySource", "source": "meddra"}], "product_url": "https://www.meddra.org/subscription"}, {"category": "GraphicalInterface", "description": "MedDRA Web-Based Browser provided for MedDRA subscribers to search and view MedDRA terminology content.", "id": "meddra.web-browser", "name": "MedDRA Web-Based Browser", "original_source": [{"relation_type": "prov:hadPrimarySource", "source": "meddra"}], "product_url": "https://mssotools.com/MSSOWeb/wbb/wbb_index.html"}, {"category": "DocumentationProduct", "description": "ICH MedDRA page describing the terminology, governance, MSSO maintenance, and regulatory use cases.", "id": "meddra.ich-page", "name": "ICH MedDRA Documentation", "original_source": [{"relation_type": "prov:hadPrimarySource", "source": "meddra"}], "product_url": "https://admin.ich.org/page/meddra"}, {"category": "Product", "description": "Quarterly data extracts in ASCII format containing demographic, drug, reaction, outcome, and source information for reported adverse events", "format": "txt", "id": "faers.quarterly_data_ascii", "latest_version": "2026Q1", "name": "FAERS Quarterly Data Files (ASCII)", "original_source": [{"relation_type": "prov:hadPrimarySource", "source": "faers"}], "product_url": "https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html", "secondary_source": [{"relation_type": "prov:wasInformedBy", "source": "meddra"}]}, {"category": "Product", "description": "Quarterly data extracts in XML format adhering to ICH E2B standards for international safety reporting", "format": "xml", "id": "faers.quarterly_data_xml", "latest_version": "2026Q1", "name": "FAERS Quarterly Data Files (XML)", "original_source": [{"relation_type": "prov:hadPrimarySource", "source": "faers"}], "product_url": "https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html", "secondary_source": [{"relation_type": "prov:wasInformedBy", "source": "meddra"}]}]
{"activity_status": "active", "category": "DataSource", "contacts": [{"category": "Organization", "contact_details": [{"contact_type": "url", "value": "https://admin.ich.org/page/meddra"}], "label": "ICH MedDRA Maintenance and Support Services Organisation"}], "creation_date": "2026-06-02T00:00:00Z", "description": "MedDRA, the Medical Dictionary for Regulatory Activities, is an ICH standardized medical terminology used internationally for registration, documentation, safety monitoring, and pharmacovigilance of medical products.", "domains": ["clinical", "biomedical", "pharmacology"], "homepage_url": "https://admin.ich.org/page/meddra", "id": "meddra", "last_modified_date": "2026-06-03T00:00:00Z", "layout": "resource_detail", "name": "MedDRA", "products": [{"category": "Product", "description": "MedDRA terminology release files maintained and distributed by the MedDRA MSSO for subscribers, supporting regulatory coding and pharmacovigilance workflows.", "id": "meddra.release-files", "name": "MedDRA Terminology Release Files", "original_source": [{"relation_type": "prov:hadPrimarySource", "source": "meddra"}], "product_url": "https://www.meddra.org/subscription"}, {"category": "GraphicalInterface", "description": "MedDRA Web-Based Browser provided for MedDRA subscribers to search and view MedDRA terminology content.", "id": "meddra.web-browser", "name": "MedDRA Web-Based Browser", "original_source": [{"relation_type": "prov:hadPrimarySource", "source": "meddra"}], "product_url": "https://mssotools.com/MSSOWeb/wbb/wbb_index.html"}, {"category": "DocumentationProduct", "description": "ICH MedDRA page describing the terminology, governance, MSSO maintenance, and regulatory use cases.", "id": "meddra.ich-page", "name": "ICH MedDRA Documentation", "original_source": [{"relation_type": "prov:hadPrimarySource", "source": "meddra"}], "product_url": "https://admin.ich.org/page/meddra"}, {"category": "Product", "description": "Quarterly data extracts in ASCII format containing demographic, drug, reaction, outcome, and source information for reported adverse events", "format": "txt", "id": "faers.quarterly_data_ascii", "latest_version": "2026Q1", "name": "FAERS Quarterly Data Files (ASCII)", "original_source": [{"relation_type": "prov:hadPrimarySource", "source": "faers"}], "product_url": "https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html", "secondary_source": [{"relation_type": "prov:wasInformedBy", "source": "meddra"}]}, {"category": "Product", "description": "Quarterly data extracts in XML format adhering to ICH E2B standards for international safety reporting", "format": "xml", "id": "faers.quarterly_data_xml", "latest_version": "2026Q1", "name": "FAERS Quarterly Data Files (XML)", "original_source": [{"relation_type": "prov:hadPrimarySource", "source": "faers"}], "product_url": "https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html", "secondary_source": [{"relation_type": "prov:wasInformedBy", "source": "meddra"}]}], "synonyms": ["Medical Dictionary for Regulatory Activities"], "warnings": ["MedDRA terminology files and browser access are controlled through the MedDRA MSSO subscription model; access conditions should be checked before reuse."]}