Release Notes 1.5.0
- 1 Ontology Development
- 1.1 Summary
- 1.1.1 Qualitative View
- 1.1.2 Quantitative View
- 1.1.3 Detailed View
- 1.1 Summary
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
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
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
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:
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:
| 70. TiotropiumbromideExample |
| 71. PharmaceuticalProcess |
| 72. CorporateOwnership |
| 73. AllFND |
| 74. MetadataFNDLaw |
| 75. CentralAmericanGovernmentEntitiesAndJurisdictions |
| 76. CentralAsiaGovernmentEntitiesAndJurisdictions |
| 77. AllFND-NorthAmerica |
| 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 |
|---|---|---|---|
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 |