The Identification of Medicinal Products (IDMP) framework (ISO 11615:2021) defined by the International Standards Organization provides a standard data model and definitions for the purpose of assisting pharmaceutical companies in describing and reporting data related to pharmaceutical and medicinal products. While the standards are now widely used and will be required for the purposes of drug submissions to the European Medicines Agency (EMA) starting in 2023, there are ambiguities that have caused challenges in representing and reporting on the relevant data. The IDMP project at Pistoia Alliance is designed to produce a companion ontology using FAIR data principles to enable semantic interoperability and provide consistent representation of medicinal products across regulatory bodies, companies, and regions. By developing an IDMP-compliant ontology with human- and machine-readable content, the Alliance will support the move towards automated reporting, improving efficiency and patient safety, reducing costs and time burden, and driving innovation in the drug development pipeline. The project is managed by the Pistoia Alliance, with a project team of experts from a number of pharmaceutical companies in the European Union and United States, supported by regulators including EMA, the Food and Drug Administration (FDA) and others.

Use Case Driven Approach

Rather than attempting to model any of the related IDMP standards in their entirety, the project team has elected to develop a set of use cases and competency questions as the target for development purposes for every release. This approach enables us to model a "slice" through the various specifications, developing test competency questions and ensuring that they are answerable for each release. These questions are mapped not only to publicly available data but internally using pharmaceutical company specific data, to ensure the efficacy of the ontology and provide incremental value at every checkpoint in the development process.  Documentation for the competency questions is provided under IDMP Ontology - Use Case Documentation.

Phase I (MVP) Release Notes

The focus for the initial phase of the project has been on the initial use case described at UC1-Parent Substance (Clinical). The focus for the MVP was also limited to single substances that are explicitly chemical substances in order to provide an end-to-end demonstration of the efficacy of the ontology and approach with respect to the lowest common denominator. This approach ensured that we could map the resulting ontology to public data such as the FDA's G-SRS repository and to internal pharmaceutical company data for what we believe is the simplest case. Subsequent releases will provide increasing coverage of other single but more complex substances as well as mixtures and specified substances, additional details from the manufacturing process, and so forth. An overview of the specific competency questions addressed and progress by a number of the participants with respect to mapping internal data is provided at UC1 Competency Questions Overview.

Documentation of the preliminary policies and procedures used to drive the ontology development as well as documentation for the various design patterns that have been implemented to date is provided under Documentation of Guidelines, Policies & Modelling Patterns

IDMP ISO Ontology Library (ISO)

The ontologies listed below represent those that are have been developed for the IDMP-O Phase 1 initiative.  

Table 3. IDMP ISO Ontology Library Ontologies with their Release Status and Approximate % Coverage

Ontology Name

Ontology IRI

Release Status

% Coverage of the IDMP Standard

ISO 11238 - Substanceshttps://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/

Most of the focus of the Phase I IDMP project was on the content of ISO 11238 - Substances.  The content that is currently included in this specification, including ontology dependencies on the Commons Ontology Library, is relatively stable and has been used to support representation of examples as well as some public data and queries represented in Use Case 1, Competency Questions (CQs) CQ 1 through CQ 8. See UC1 Competency Questions Overview for details related to the use case and its competency questions.

Coverage of the contents of the ISO 11238 standard as of the end of the Phase I project is estimated at 45%, including coverage of some of the details from the companion 19844 implementation guide.

ISO 11238 - Registration Authoritieshttps://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/

The ISO 11238 - Registration Authorities ontology covers a number of RAs and the data sets they manage that have either been mentioned by pharmaceutical company team members as important or that are used as the basis for example and reference data for Phase I.

Coverage of the RAs and repositories mentioned in the ISO 11238 specification is approximately 70%.
ISO 11239 - Pharmaceutical Dose Formshttps://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11239-PharmaceuticalDoseForms/The ISO 11239 - Pharmaceutical Dose Forms ontology is essentially a stub with limited coverage of the standard including references for definitions used elsewhere.Coverage is limited to roughly 5% or less of the specification.
ISO 11240 - Units of Measurementhttps://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11240-UnitsOfMeasurement/

The ISO 11240 - Units of Measurement ontology is stable and relatively complete given its reuse on the Commons Ontology Library (CMNS) Quantities and Units ontology. The Quantities and Units ontology, developed in conjunction with the U.S. National Institute of Standards and Technology as well as the Object Management Group (OMG)'s Systems Engineering Domain Special Interest Group (SE DSIG), largely reflects the model of quantities and units developed for use with the OMG's Systems Engineering Modeling Language that is best known by its acronym, SysML. It is well aligned with the Quantities, Units, Dimensions and Values (QUDV) Annex to the SysML standard and with additional work done by the SE DSIG on the SysML v2.0 specification whose latest draft is under review for adoption in December 2022. 

The Quantities and Units ontology itself is awaiting publication at OMG, with a planned release date of March 2022, although it has been stable for a number of months, with only minor changes over the course of the MVP based on usage experience.

Coverage of the terms and definitions section of the ISO 11240 specification in the combined ISO 11240 and Commons Quantities and Units ontologies and the ontologies in Commons they depend on together with other IDMP ontologies is 75%.

Coverage of the abbreviations given in clause 3 of the specification across the various ontologies mentioned above is 55%.

Coverage of the additional content provided in clause 4 of the specification across the various ontologies mentioned above plus the extension for the UCUM provided in the EXT/Extensions/UnifiedCodeForUnitsOfMeasure preliminary ontology, including the high-level model provided in Figure 1 and more detailed model provided in Figure 2, as well as the more detailed domain model expressed in clause 4.6 is approximately 75%.

Coverage of the mapping to other standards provided in Annex B is 0%, but could be added if there is a use case requiring it in the future.

The ontology itself is designed to be mapped to other quantities and units ontologies, such as the ontology provided at qudt.org, although such a mapping has not been completed due to issues in the QUDT ontology that make in incompatible with the W3C Web Ontology Language (OWL).

ISO 11615 - Medicinal Productshttps://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/

The ISO 11615 - Medicinal Products ontology was developed as a secondary focus of the Phase I project based on the need for certain concepts in order to answer some of the extended Competency Questions (CQs), such as those related to the basis of strength examples. What is there is relatively stable, but subject to change as coverage of this specification increases over time. We anticipate extensions, for example, in Phase II due to emerging CQs related to the integration of regulatory requirements and manufacturing.

Coverage of the contents of the ISO 11615 standard as of the end of the Phase I project is estimated at 15% to 20%, including coverage of some of the details from the companion 20443 implementation guide.

ISO 11616 - Pharmaceutical Productshttps://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11616-PharmaceuticalProducts/The ISO 11616 - Pharmaceutical Products ontology is essentially a stub with limited coverage of the standard including references for definitions used elsewhere.Coverage is limited to roughly 5% or less of the specification.
ISO 21090 - Harmonized Datatypeshttps://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO21090-HarmonizedDatatypes/

The ISO 21090 - Harmonized Datatypes ontology is well underway and we consider this version to be stable. Additional content will be added to complete coverage, but the approach and patterns used for development purposes will not change.

The intent with respect to development of the MVP / Phase I version of this ontology was to cover only those datatypes used in the ISO 11238 Substances and ISO 19844 Implementation Guide rather than providing complete coverage for all datatypes in the standard. From the perspective of the ISO 11238 standard, the codes for the relevant datatypes are largely present in diagrams, but are not discussed elsewhere.  The ISO 19844 guide provides significantly more detail. 

The codes for the relevant datatypes that are mentioned in ISO 11238/19844 include: II, CD, INT, TS, ST, TS.DATE, BL, PQ, ED, CD.CodeSystem, CD.CodeSystemName, and CD.Code. Some of these are mapped to more complete concepts in the IDMP ontology, and others are simply mapped to the corresponding XML Schema Datatype per the W3C Resource Description Framework (RDF), RDF Schema, and Web Ontology Language (OWL) specifications. Coverage of the codes listed above in the ontology includes all of the primary codes, but does not yet include TS.DATE, CD.CodeSystem, CD.CodeSystemName, and CD.Code, though the ontology, including its dependencies, supports the definition of such values. The remaining codes will be added in a subsequent version of the ontology, together with any additional codes required for the next phase of the project.

Further discussion of how to use these datatype codes and how they are implemented in the phase I released ontologies is provided at Patterns for Modeling with the ISO 21090 Harmonized Datatypes for the Identification of Medicinal Products. While this document does not cover some of the codes that have been implemented, the patterns described therein provide hints and examples that users of this ontology should find helpful.

Coverage with respect to the required codes to represent the ISO datatypes present in the ISO 11238 standard is roughly 66%. Coverage with respect to the ISO 21090 specification is closer to 15% as of this release.

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