Release Notes 1.5.0

Release Notes 1.5.0

Ontology Development

Summary

The 1.5.0 release of IDMP-O (Identification of Medicinal Products Ontology) is based on development work accomplished in 2025. Two primary use cases were addressed in this release: (1) cross-jurisdiction regulatory reporting, with a focus on the use of controlled vocabularies that differ from jurisdiction to jurisdiction, for dose forms, ingredient roles, basis of strength, and related concepts, and (2) batch tracking involving multiple manufacturers, sites, batches, and lots. These use cases built on prior work in jurisdiction-specific representation and supply chain, but were driven by steering committee members with real data that we could leverage to show how the ontology could be used internally to address the competency questions provided. Many additional examples (all fragments for various existing or hypothetical products) were added, and gaps uncovered in IDMP-O were addressed in order to facilitate demonstrations and actual implementation. From a maintenance perspective, a number of additional issues were addressed, including several related to improving the structure of the non-ISO-IDMP content provided, such as consolidating controlled vocabularies used in examples, consolidating external ontologies used either in the released IDMP-O ontologies or in examples, creating a new folder for mappings, and so forth. Other maintenance issues addressed emerging metadata requirements from Pistoia Alliance, as well as feedback from users. Planned work for a 1.6.0 release towards the end of Q1 2026 will include fleshing out some of the newer vocabularies and examples, cleaning up issues reported by users or uncovered in implementation to date, and other emerging requirements from Pistoia Alliance. Additional mappings to demonstrate interoperability between IDMP-O and other external and Pistoia ontologies, such as the CMC ontology, will also be included in the 1.6.0 revision.

Qualitative View

  1. Structural Modifications - These include:

  • Replacing placeholder ontologies that had been under CMNS for geopolitical entities, which did not dereference, with their equivalents from the Financial Industry Business Ontology (FIBO), which are part of the FIBO standard and do dereference properly, with inclusion of the relevant FIBO ontologies for reference purposes in the IDMP GitHub

  • Inclusion of new and revised ontologies from Object Management Group (OMG)'s Commons Ontology Library v1.3 and Multiple Vocabulary Facility v1.1 under CMNS and MVF respectively, and revising references to the relevant concepts in IDMP-O as needed

  • Consolidating the various jurisdiction-specific regulatory agencies and registration authorities required either by the ISO IDMP specifications or as needed for examples under a single, ISO/JurisdictionSpecificAgencies folder and releasing those that were ready for release

  • Consolidating non-ISO IDMP vocabularies in a new VOCAB folder rather than having them distributed between the ISO, EXT, SPAR, and other locations and releasing those that were ready for release

  • Moving the examples from EXT/Examples to EXMP for simplification and to clarify for IDMP users exactly what they are so that they can be easily excluded from operational implementations as appropriate

  • Creating new CMC, IOF and MAP folders to cache the Pistoia CMC ontology used in our batch tracking use case, cache the set of IOF (Industrial Ontologies Foundry) and related BMIC (formerly NIIMBL) ontologies used in our batch tracking use case, and new mapping ontologies for use in linking between IDMP-O and the CMC ontology (which will be further developed for 1.6.0

  1. Content Modifications - These include:

  • Many new example ontologies needed to support the two Phase 4 use cases mentioned above, including competency questions, the content needed to answer those questions, and their addition to the set of regression tests used when changes are made to any IDMP-O ontology

  • A number of new vocabularies and revisions to existing vocabularies, particularly in support of the regulatory reporting use case

  • Release of several jurisdiction-specific vocabularies and the addition of a new provisional vocabulary for the regulatory agencies and registration authorities used in IDMP-O, which will be further extended in 2026 as needed

  • Additional metadata to cover emerging Pistoia requirements

  • Revisions to the main IDMP-O ontologies as needed either due to (1) better understanding of the ISO specifications, (2) bug fixes, and (3) requirements that emerged from implementation of the new use cases or in general from project stakeholders

  1. New consolidated ontologies reflecting only the released content for IDMP-O 1.2.0 and 1.3.0 - in these cases, the content from each of those releases was merged into a single file for ease of use by academics and others that do not need the external ontologies, vocabularies, or examples that are part of the full scope of IDMP-O. A similar consolidated ontology will be available in early 2026 for the 1.4.0 and 1.5.0 versions of IDMP-O.

Quantitative View

One ontology was removed:

  1. MetadataEXT

 

One hundred and thirty eight ontologies were added, including (1) many new cached external references to the Financial Industry Business Ontology (FIBO), Industrial Ontologies Foundry (IOF), and Pistoia Chemistry, Manufacturing, and Controls (CMC) ontology, (2) many new examples and vocabularies, and (3) related metadata files for new folders:

  1. LegalCapacity

70. TiotropiumbromideExample

  1. EtanerceptExample

71. PharmaceuticalProcess

  1. MappingCommonsToBFO

72. CorporateOwnership

  1. SwissIngredientRoles

73. AllFND

  1. MappingIDMPOToBFO

74. MetadataFNDLaw

  1. DenosumabExample

75. CentralAmericanGovernmentEntitiesAndJurisdictions

  1. Facilities

76. CentralAsiaGovernmentEntitiesAndJurisdictions

  1. AccountingEquity

77. AllFND-NorthAmerica

  1. Control

78. IdentifiersAndIndices

10. MappingMVFToBFO

79. Material

11. AllBE-NorthAmerica

80. RealProperty

12. MetadataFNDAgreements

81. Lifecycles

13. Parties

82. MXGovernmentEntitiesAndJurisdictions

14. MetadataFNDOrganizations

83. Partnerships

15. AmericanDoseForms

84. AboutIDMP-O-and-BFO

16. MetadataBEOwnershipAndControl

85. Corporations

17. LinagliptinExample

86. ClassificationSchemes

18. MetadataBESoleProprietorships

87. MetadataFNDAgentsAndPeople

19. Ratings

88. MetadataBEPartnerships

20. Agents

89. USPostalServiceAddressesIndividuals

21. MetadataFNDParties

90. Executives

22. MetadataBECorporations

91. Trusts

23. REATransactions

92. SoutheasternAsiaGovernmentEntitiesAndJurisdictions

24. MetadataBE

93. LEIEntities

25. USExampleEntities

94. MetadataFNDOwnershipAndControl

26. SouthAmericanRegulatoryAgencies

95. CorporateControl

27. IdentificationOfMedicinalProductsOntology

96. PrivateLimitedCompanies

28. MetadataEXMP

97. Jurisdiction

29. MetadataFNDGoalsAndObjectives

98. Physical

30. SouthernAsiaGovernmentEntitiesAndJurisdictions

99. AllBE

31. Recipe

100. EmpagliflozinExample

32. EasternAsiaGovernmentEntitiesAndJurisdictions

101. ApremilastExample

33. MetadataFNDPlaces

102. FinancialDates

34. CanadianDoseForms

103. People

35. TiotropiumolodaterolExample

104. Objectives

36. ArgentinianIngredientRoles

105. MetadataBEPrivateLimitedCompanies

37. VirtualPlaces

106. MetadataFNDAccounting

38. MetadataFNDArrangements

107. OwnershipParties

39. MetadataFNDTransactionsExt

108. Ownership

40. FormalBusinessOrganizations

109. MetadataFND

41. MetadataBEFunctionalEntities

110. CinacalcetExample

42. Analytics

111. MetadataFNDRelations

43. Arrangements

112. CorporateBodies

44. AllBE-NorthAmericanExamples

113. CashFlows

45. CurrencyAmount

114. EvolocumabExample

46. CarfilzomibExample

115. MetadataBEGovernmentEntities

47. Publishers

116. MetadataFNDUtilities

48. USExampleExecutives

117. Product1Example

49. AllBE-Europe

118. AllBE-ReferenceIndividuals

50. USPostalServiceAddresses

119. Contracts

51. SecuritiesTransactions

120. BlinatumomabExample

52. MetadataFNDDatesAndTimes

121. PegfilgrastimExample

53. Assessments

122. MetadataBELegalEntities

54. Core

123. SoleProprietorships

55. Occurrences

124. PaymentsAndSchedules

56. LegalCore

125. Languages

57. SotorasibExample

126. ChileanIngredientRoles

58. LegalPersons

127. MarketTransactions

59. MetadataFIBO

128. Product2Example

60. AllBE-ExampleIndividuals

129. MetadataVOCAB

61. ControlParties

130. ExtendedEudraVigilenceProductRolesAndCodes

62. DabigatranExample

131. FormalOrganizations

63. MetadataFNDProductsAndServices

132. BusinessAuthorizations

64. CaribbeanGovernmentEntitiesAndJurisdictions

133. IpratropiumbromideExample

65. ISO4217-CurrencyCodes

134. SouthAmericanGovernmentEntitiesAndJurisdictions

66. OwnershipAndControl

135. FunctionalEntities

67. Relations

136. MetadataBETrusts

68. ManufacturingExecution

137. Agreements

69. BusinessDates

138. Reporting

The following ontologies were revised and/or extended, including, structural moves, reflected in cases where resources were deleted and readded:

Ontologies

Deleted Resources

New Resources

Modified Resources

Ontologies

Deleted Resources

New Resources

Modified Resources

Addresses

83

77

0

AmlodipineExample

76

76

167

AnnotationVocabulary

0

5

0

CAGovernmentEntitiesAndJurisdictions

42

42

0

CommonTerminologyCriteriaForAdverseEvents

10

10

0

ContextualDesignators

0

0

3

DatesAndTimes

0

0

4

Designators

0

2

4

doco

0

0

14

DocumentComponents

23

23

0

Documents

16

5

0

EasternEuropeGovernmentEntitiesAndJurisdictions

30

30

0

EUGovernmentEntitiesAndJurisdictions

8

8

0

EuropeanRegistrationAuthorities

30

30

0

EuropeanRegulatoryAgencies

6

9

0

EuropeanUnionClinicalTrialsRegister

41

41

11

GovernmentEntities

29

36

0

ISO1087-TerminologyScience

0

10

5

ISO1087-VocabularyForTermsAndDefinitions

2

2

13

ISO11238-RegistrationAuthorities

8

2

10

ISO11238-Substances

0

0

68

ISO11239-PharmaceuticalDoseForms

0

0

1

ISO11240-UnitsOfMeasurement

0

0

2

ISO11615-MedicinalProducts

1

11

80

ISO11616-PharmaceuticalProducts

0

0

1

ISO21090-HarmonizedDatatypes

0

9

13

ISO5218-RepresentationOfHumanSexes

11

11

0

LanguageRepresentation

0

0

2

Locations

43

18

1

MedicalDictionaryForRegulatoryActivities

18

18

0

MetadataIDMP

0

0

2

MetadataISO