1 Ontology Development
- 1.1 Summary
  - 1.1.1 Qualitative View
  - 1.1.2 Quantitative View
  - 1.1.3 Detailed View

Ontology Development

Summary

Qualitative View

Significant additional content was added to the IDMP-O ontologies in the Q3 2024, 1.3 release. New material covers parts of the ISO 11615 standard related to marketing authorizations, marketing status, manufacturing authorizations, manufacturers, manufacturing / business operations and related concepts, and so forth. These additions were made primarily to address new use cases, such as the EMA SPOR PMS-related use case, but have increased our coverage of the specification at the same time in preparation for inclusion of the ontology in the set of ISO standards for Identification of Medicinal Products. In addition, we have addressed numerous bug fixes and inconsistencies identified through existing and newly added hygiene testing, thereby increasing the quality of the ontologies. The latest release of the Object Management Group’s Commons Ontology Library v1.3 has also been integrated in advance of formal publication in the OMG’s specification catalog, anticipated in Q4. Dereferenceable ontologies corresponding to 5 that are currently only available in GitHub, used by IDMP-O, will be available directly from the OMG site before the end of the year (final approval is quorate with voting underway).

Quantitative View

No ontology was added or deleted.

The following ontologies were revised and/or extended:

Ontologies	Deleted Resources	New Resources	Modified Resources

Ontologies	Deleted Resources	New Resources	Modified Resources
AmlodipineExample	0	0	1
Classifiers	0	0	2
CommonTerminologyCriteriaForAdverseEvents	0	0	3
Designators	0	2	1
doco	0	0	14
DocumentComponents	0	0	5
EUGovernmentEntitiesAndJurisdictions	0	0	1
EuropeanRegistrationAuthorities	0	1	20
EuropeanUnionClinicalTrialsRegister	0	0	1
GovernmentEntities	0	0	11
ISO1087-TerminologyScience	0	0	1
ISO1087-VocabularyForTermsAndDefinitions	0	0	2
ISO11238-RegistrationAuthorities	0	0	8
ISO11238-Substances	0	0	45
ISO11239-PharmaceuticalDoseForms	0	0	1
ISO11240-UnitsOfMeasurement	0	0	3
ISO11615-MedicinalProducts	0	60	53
ISO11616-PharmaceuticalProducts	0	0	1
ISO21090-HarmonizedDatatypes	0	11	1
Locations	5	28	12
MedicalDictionaryForRegulatoryActivities	0	0	3
NorthAmericanRegistrationAuthorities	0	0	30
Organizations	2	15	14
po	0	0	8
ProductsAndServices	6	0	13
PublicHealthInformationNetwork	0	0	2
QlairaExample	0	0	1
QuantitiesAndUnits	5	2	7
RegistrationAuthorities	5	0	13
RegulatoryAgencies	5	0	8
StatisticalMeasures	3	0	8
StructuredCollections	0	0	5
SubstancesProductsOrganisationsReferentials	1	4	12
TerlipressinExample	0	0	1
UKGovernmentEntitiesAndJurisdictions	0	0	1

Detailed View

resources in 1.2.0 but not 1.3.0 release

Ontologies	Resources

Ontologies	Resources
RegistrationAuthorities	https://www.omg.org/spec/Commons/RegistrationAuthorities/isRelatedTo
RegistrationAuthorities	https://www.omg.org/spec/Commons/RegistrationAuthorities/isDesignatedBy
RegistrationAuthorities	https://www.omg.org/spec/Commons/RegistrationAuthorities/isManagedBy
RegistrationAuthorities	https://www.omg.org/spec/Commons/RegistrationAuthorities/designates
RegistrationAuthorities	https://www.omg.org/spec/Commons/RegistrationAuthorities/manages
Organizations	https://www.omg.org/spec/Commons/Organizations/OrganizationPartIdentifier
Organizations	https://www.omg.org/spec/Commons/Organizations/Group
StatisticalMeasures	https://www.omg.org/spec/Commons/StatisticalMeasures/Total
StatisticalMeasures	https://www.omg.org/spec/Commons/StatisticalMeasures/RatioValue
StatisticalMeasures	https://www.omg.org/spec/Commons/StatisticalMeasures/Ratio
ProductsAndServices	https://www.omg.org/spec/Commons/ProductsAndServices/ServiceProvider
ProductsAndServices	https://www.omg.org/spec/Commons/ProductsAndServices/Capability
ProductsAndServices	https://www.omg.org/spec/Commons/ProductsAndServices/Service
ProductsAndServices	https://www.omg.org/spec/Commons/ProductsAndServices/isProvidedTo
ProductsAndServices	https://www.omg.org/spec/Commons/ProductsAndServices/provides
ProductsAndServices	https://www.omg.org/spec/Commons/ProductsAndServices/isProvidedBy
RegulatoryAgencies	https://www.omg.org/spec/Commons/RegulatoryAgencies/LicenseIdentifier
RegulatoryAgencies	https://www.omg.org/spec/Commons/RegulatoryAgencies/License
RegulatoryAgencies	https://www.omg.org/spec/Commons/RegulatoryAgencies/GovernmentIssuedLicense
RegulatoryAgencies	https://www.omg.org/spec/Commons/RegulatoryAgencies/Licensee
RegulatoryAgencies	https://www.omg.org/spec/Commons/RegulatoryAgencies/Licensor
SubstancesProductsOrganisationsReferentials	https://spec.pistoiaalliance.org/idmp/ontology/ISO/EuropeanJurisdiction/SubstancesProductsOrganisationsReferentials/ReferentialsManagementServicesRegistrationScheme
Locations	https://www.omg.org/spec/Commons/Locations/isLocatedAt
Locations	https://www.omg.org/spec/Commons/Locations/hasURL
Locations	https://www.omg.org/spec/Commons/Locations/hasWebsite

resources in 1.3.0 but not in v1.2.0 release

Ontologies	Resources

Ontologies	Resources
EuropeanRegistrationAuthorities	https://spec.pistoiaalliance.org/idmp/ontology/ISO/EuropeanJurisdiction/EuropeanRegistrationAuthorities/ExtendedEudraVigilanceMedicinalProductDictionaryScheme
Designators	https://www.omg.org/spec/Commons/Designators/hasTextualName
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/LegalGrounds
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ChangeRequestOrganizationType
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/Matter
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ConcentrationStrength
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/GeographicAreaForActionTaken
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ValidityPeriod
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/AuthorizationStatus
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ManufacturingSite
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ConfidentialityIndicator
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/LegalStatusOfSupply
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ManufacturingOperationType
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/MarketingProcedureClassifier
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ConditionToRestoreAuthorization
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/AuthorizationStatusCode
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/MarketingAuthorizationApplicationClassifier
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/DataExclusivityPeriod
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasDateOfFirstAuthorization
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/isProducedByManufacturingOperation
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/isProducedAtManufacturingSite
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasMarketingStopDate
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasDataExclusivityPeriod
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasAuthorizationProcedure
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/manufacturesAtSite
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasAuthorizationStatus
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/authorizesManufacturingOf
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasMarketingStartDate
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/manufacturesInRegion
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/isApplicableInCountry
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasRestoreDate
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasConfidentialityIndicator
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasInternationalBirthDate
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/authorizesManufacturingAt
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasScientificNamePart
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasTargetPopulationPart
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasTimePeriodPart
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasFullMedicinalProductName
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasStatusReasonComment
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasRiskOfSupplyShortageComment
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasLegalGroundsComment
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasFlavorPart
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasCompanyNamePart
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasDelimiterPart

Release Notes 1.3.0

Ontology Development

Summary

Qualitative View

Quantitative View

Detailed View