EMA SPOR: SMS, OMS, RMS

EMA SPOR: SMS, OMS, RMS

General Alignment Structure

Create different modules for:

  1. SMS

  2. OMS

  3. RMS: one graph per list

URI Pattern for SPOR Data

We use recently published URLs. Motivation: EMA authority, RDF Compliant

Examples:

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

SPOR OMS Column

Example Row

IDMP-O Mapping

Organisation ID

ORG-100003912

<https://spor.ema.europa.eu/v1/organisations/{ ?Organisation_ID }>
        a cmns-org:LegalEntity.

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

https://spor.ema.europa.eu/v1/locations/LOC-100000000

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