EMA SPOR: SMS, OMS, RMS
General Alignment Structure
Create different modules for:
SMS
OMS
RMS: one graph per list
URI Pattern for SPOR Data
We use recently published URLs. Motivation: EMA authority, RDF Compliant
Examples:
https://spor.ema.europa.eu/v1/lists/200000000004/terms/100000173972
https://spor.ema.europa.eu/v1/lists/SubstanceDefinition/terms/100000085259
https://spor.ema.europa.eu/v1/locations/LOC-100000551
...
There is a version v2 for substance, but this works with UUIDs as identifier. We will not use this for the moment.
Substances (SMS)
URI Patterns:
Substance Entity URI: https://spor.ema.europa.eu/v1/lists/SubstanceDefinition/terms/100000085259
SPOR SMS Column | Example Row | Alignment to IDMP-O |
|---|---|---|
#SMS_ID | 100000085259 |
|
Substance_Name | Amlodipine | skos:prefLabelnMap to skos:prefLabel or skos:altLabel (subproperties of rdfs:label) depending on next column value |
Is_Preferred_Name | TRUE | TRUE=prefLabel, FALSE=altLabel |
Language | English | Add language tag, e.g., "@en" for English |
Name_Source | INN | If not empty, add (contextualized) substance name with corresponding name sources <S> cmns-dsg:hasName [ hasTextValue "Amlodipine" ; rdf:type idmp-sub:SubstanceName ; dct:source <Authority/RegistryURI> . # use of String reference for authorities that need to be added |
Substance_Domain | Human use | Reference to SPOR RMS code list object URI. Preliminary with SKOS property <https://www.omg.org/spec/Commons/Classifiers/isClassifiedBy> <https://spor.ema.europa.eu/v1/lists/100000000004/terms/100000000012> |
Status | Current | (ignore for now) |
Substance_Type | Chemical | rdf:type idmp-sub:ChemicalSubstance (see mapping table below on "Substance Type") |
Created_Date | 25.07.2019 11:55 | dct:created |
Last_Updated_Date | 21.06.2021 07:58 | dct:modified |
External_Code_XEVMPD | SUB05467MIG | <S> cmns-id:isIdentifiedBy <https://data.pistoiaalliance.org/id/EVMPD/SUB14568MIG> (preliminary URI) which is an instance of idmp:EudraVigilanceCode & cmns-ra:RegisteredIdentifier |
External_Code_SVG |
| (ignore for now) |
External_Code_UNII | 1J444QC288 | <S> skos:exactMatch <https://gsrs.ncats.nih.gov/api/v1/substances/82Y7NT6DFT> (match to GSRS substance) <S> cmns-id:isIdentifiedBy <https://data.pistoiaalliance.org/id/FDA_UNII/1J444QC288> (preliminary URI) |
Coverage to IDMP
Substance Type Alignment: SPOR → IDMP-O
prefix spor-st: <https://spor.ema.europa.eu/v1/lists/100000075826/terms/>
SPOR SMS used Substance Type | Target IDMP Ontology Class | SPOR RMS Substance Type (list 100000075826) |
|---|---|---|
Chemical | idmp-sub:ChemicalSubstance | spor-st:100000075670 |
Mixture | idmp-sub:Mixture | spor-st:200000005023 |
Nucleic acid | idmp-sub:NucleicAcidSubstance | spor-st:200000005035 |
Polymer | idmp-sub:PolymerSubstance | spor-st:200000005022 |
Protein | idmp-sub:ProteinSubstance | spor-st:200000005020 |
Specified Substance Group 1 | idmp-sub:SpecifiedSubstanceGroup1 | spor-st:200000005031 |
Specified Substance Group 2 | not found in data. Mapped to idmp-sub:SpecifiedSubstanceGroup2 | spor-st:200000005032 |
Specified Substance Group 3 | idmp-sub:SpecifiedSubstanceGroup3 | spor-st:200000005033 |
Specified Substance Group 4 | not found in data. Mapped to idmp-sub:SpecifiedSubstanceGroup4 | spor-st:200000005034 |
Structurally Diverse - Allergen | not covered so far. Fallback to idmp-sub:StructurallyDiverseSubstance | spor-st:200000005026 |
Structurally Diverse - Cell therapy | not covered so far. Fallback to idmp-sub:StructurallyDiverseSubstance | spor-st:200000005029 |
Structurally Diverse - Herbal | not covered so far. Fallback to idmp-sub:StructurallyDiverseSubstance | spor-st:200000005025 |
Structurally Diverse - Other | not covered so far. Fallback to idmp-sub:StructurallyDiverseSubstance | spor-st:200000005030 |
Structurally Diverse - Plasma derived | not covered so far. Fallback to idmp-sub:StructurallyDiverseSubstance | spor-st:200000005024 |
Structurally Diverse - Vaccine | not covered so far. Fallback to idmp-sub:StructurallyDiverseSubstance | spor-st:200000005027 |
Name Source
There 50 sources/authorities/companies name. And below is the list the name that IDMP already covered.
Full list used in SPOR SMS:
JAN
ADISINSIGHT
BAN
BRITISH HERBAL PHARMACOPOEIA
BRITISH PHARMACOPOEIA
CHEBI
CHEMICAL ABSTRACT SERVICE
CHEMICALBOOK
CHEMIDPLUS
CHINESE PHARMACOPOEIA
COLORCON
COMMUNITY HERBAL MONOGRAPHS
COMMUNITY REGISTER OF THE EUROPEAN COMMISSION
COMPANY SPECIFICATION
COSING
CZECH PHARMACOPOEIA
DEUTSCHES ARZNEIBUCH
ENCYCLOPEDIA OF LIFE (EOL)
EUROPEAN CHEMICALS AGENCY (ECHA)
EUROPEAN FOOD SAFETY AUTHORITY (EFSA)
EUROPEAN PHARMACOPOEIA
FDA INACTIVE INGREDIENTS DATABASE
FDA SUBSTANCE REGISTRATION SYSTEM
FRENCH PHARMACOPOEIA
GLOBAL DIVERSITY INFORMATION FACILITY
GREEK PHARMACOPOEIA
HAB
HANDBOOK OF PHARMACEUTICAL EXCIPIENT (2ND EDITION)
HOMEOPATHIC PHARMACOPOEIA OF THE UNITED STATES
INDEX FUNGORUM
INFLUENZA RECOMMENDATIONS
INN
INTERNATIONAL CODE OF NOMENCLATURE OF BACTERIA (ICNB)
INTERNATIONAL NUMBERING SYSTEM (INS) FOR FOOD ADDITIVES
INVESTIGATOR'S BROCHURE
ITALIAN PHARMACOPOEIA
ITIS (INTEGRATED TAXONOMIC INFORMATION SYSTEM)
JAPANESE PHARMACOPOEIA
KEW GARDEN- IPLANTS DATABASE
MARTINDALE
POLISH PHARMACOPOEIA
PROTEIN DATA BANK (PDB)
PUBCHEM
SPC
Substance Validation Group
THE MERCK INDEX 20TH EDITION
THE PLANT LIST
USAN
USP
WHO
SPOR Name Source / Authority | IDMP Mapping |
|---|---|
CHEBI | idmp-eura:ChemicalEntitiesOfBiologicalInterest |
CHEMICAL ABSTRACT SERVICE | idmp-nara:ChemicalAbstractsService |
EUROPEAN CHEMICALS AGENCY (ECHA) | idmp-eurga:EuropeanChemicalsAgency |
FDA SUBSTANCE REGISTRATION SYSTEM | idmp-nara:FoodAndDrugAdministrationRegistrationAuthority |
INN | idmp-ra:InternationalNonproprietaryName |
ITIS (INTEGRATED TAXONOMIC INFORMATION SYSTEM) | idmp-nara:IntegratedTaxonomicInformationSystem |
PUBCHEM | idmp-nara:PubChem |
THE MERCK INDEX 20TH EDITION | idmp-ra:MerckIndexOnline |
USP | idmp-nara:USPharmacopeiaMedicinesCompendium |
WHO | idmp-ra:WorldHealthOrganization |
Organizations (OMS)
https://spor.ema.europa.eu/v1/searchOrganisations
Note: For now the target model uses IDMP-O and https://schema.org/
SPOR OMS Column | Example Row | IDMP-O Mapping |
|---|---|---|
Organisation ID | ORG-100003912 | <https://spor.ema.europa.eu/v1/organisations/{ ?Organisation_ID }> |
Identifier Code | ORG-100011062¦ORG-100012803¦ORG-100003912 | https://www.omg.org/spec/Commons/Identifiers/isIdentifiedBy <https://data.pistoiaalliance.org/id/OMS/{ ?Organisation_ID }> |
Mapping Code System | 100000167429¦100000167429¦200000005700 | skipped for now |
Mapping Code System Name | European Inspections Database¦European Inspections Database¦EudraVigilance Veterinary Dynamics | skipped for now |
Mapping Code | 19301¦22802¦ | skipped for now |
Mapping Valid From | ¦¦ | skipped |
Mapping Valid To | ¦¦ | skipped |
Category Classification Category Code System Name | Type¦Type | skipped |
Category Classification Category Code | 200000000084¦200000000088 | Map to RMS-OMS-Party-Category skos:broader <https://spor.ema.europa.eu/v1/lists/200000000015/terms/200000000084> skos:broader <https://spor.ema.europa.eu/v1/lists/200000000015/terms/200000000088> Split in case of multiple values. NB: Need to confirm the skos:broader usage |
Category Classification Category Display Name | Regulatory Authority¦EEA National Competent authority | skipped as it comes with reference to the RMS-OMS-Party-Category list (row above) |
Status | ACTIVE | Map to RMS-Organisation-Role-Status skos:note <?URI> ?URI as: PROVISIONAL → https://spor.ema.europa.eu/v1/lists/220000000026/terms/220000000027 ACTIVE → https://spor.ema.europa.eu/v1/lists/220000000026/terms/220000000028 INACTIVE → https://spor.ema.europa.eu/v1/lists/220000000026/terms/220000000029 DELETED → https://spor.ema.europa.eu/v1/lists/220000000026/terms/220000000030 |
Name | Austrian Agency For Health And Food Safety | skos:prefLabel "Austrian Agency For Health And Food Safety" |
Acronym | AGES | skos:altLabel "AGES" |
Alternative Name | Österreichische Agentur Für Gesundheit Und Ernährungssicherheit GmbH | skos:altLabel "Österreichische Agentur Für Gesundheit Und Ernährungssicherheit GmbH"@DE Use together with Alternative Name Language Split in case of multiple values |
Alternative Name Language | DE | used for skos:altLabel see above |
Version Timestamp | 2022-07-15T16:38:31.896+02:00 | skipped / another version timestamp below |
Location ID | LOC-100000000 | Use to create a URI and Label <https://spor.ema.europa.eu/v1/locations/{ ?Location_ID }> a schema:PostalAddress ; skos:prefLabel ?Location_ID ; |
Location Link Href | rdfs:seeAlso <https://spor.ema.europa.eu/v1/locations/LOC-100000000> | |
Current Version | Y | skipped |
Mapping Code System | 100000172923 | skipped |
Mapping Code System Name | European Inspections Database organisation system key | skipped |
Mapping Code | 22802 | skipped |
Status | ACTIVE | skos:note "ACTIVE" |
Address PO Box |
| schema:postOfficeBoxNumber ?Address_PO_Box |
Address Postal Code | 1220 | schema:postalCode "1220" Only use the first one in case of multiple values |
Address Country Code | AT | skipped for now (will be used when we have decided on the Country reference list) |
Address Country Display Name | Austria | schema:addressCountry "Austria" Only use the first one in case of multiple values (see the comment from the above row) |
Address GPS Location |
| skipped for now |
Address Language | EN¦DE | skipped for now |
Address Line 1 | Spargelfeldstrasse 191¦Spargelfeldstraße 191 | schema:streetAddress "Spargelfeldstrasse 191\n<Address Line 2 (if exists)>\n<Address Line 3 (if exists)>\n<Address Line 4 (if exists)>" Only use the first one in case of multiple values |