GIDWG: getting IDMP done
Implementing the IDMP standards is complicated and requires careful planning, organisation and coordination. The Global IDMP Working Group was set up to do just that.
A Global IDMP Working Group (GIDWG) was formed in October 2021 as an outcome of the 2019 IDMP Workshop hosted in Geneva by WHO. GIDWG was set up to pursue projects leading to the establishment of a framework for the global implementation of the ISO IDMP standards and maintenance of global identifiers. It works with the ISO Technical Committee on Health Informatics Working Group 6 (ISO TC 215 WG6) and the Health Level Seven (HL7) Working Group on global health data interoperability.
GIDWG members come from the European Medicines Agency, US FDA and UMC but the goal is to expand to a larger working group as IDMP implementation picks up pace. UMC provides subject matter experts to define processes, best practices, and an operating model for global PhPID.
Planned and ongoing projects
GIDWG is currently planning and actively working towards five projects to do with the different elements for PhPID production; Global Substance ID, Global Dose Form Identifier, Global Strength Definitions Identifier, HL7 FHIR for IDMP, and a Global PhPID operating model.
- Global Substance Identifier
The goal of this project is to harmonise and define the capture of standardised information for global substance identification and ensure consistent PhPID construction by:
- Identifying the core information set via the ISO TC 215 WG6 signature field sub-group.
- Adopting a global substance identifier.
- Establishing a global maintenance organisation.
- Establishing a framework within ISO 11238 or an additional technical specification for the unique identification of substances.
- Global Dose Form Identifier
The goal of this project is to harmonise and define the capture of standardised information for global dose form identification and ensure consistent PhPID construction by:
- Evaluating dose form characteristics (and codes) for PhPID generation using a larger data set.
- Establishing business rules for using dose form characteristics in PhPID generation.
- Global Strength Definitions Identifier
The goal of this project is to harmonise and define the capture of standardised information for global strength definitions identification and ensure consistent PhPID construction by:
- Clarifying requirements, structures and rules for strength expression according to the ISO IDMP standard.
- Further developing and evaluating the FDA/WHO-UMC pilot concepts on how to use strength presentation versus strength concentration for different products.
- Defining the use of units, value figures and unit of presentation.
- FHIR HL7 for IDMP
The goal of this project is to participate in the development, verification, and ballot of HL7 FHIR resources related to IDMP for the successful exchange of medicinal product and substance information.
- Operating model for PhPID construction
The goal of this project is to define the operating model for global PhPIDs by:
- Identifying the main requirements of regulators, industry, healthcare providers, and other stakeholders.
- Developing a proposal for a solution to provide the information needed regarding quality, timelines, and access.
- Establishing business rules for PhPID generation and assess feasibility of publishing in ISO technical report.
- Establishing a global maintenance organisation and proposed framework and processes for international working group.
GIDWG stakeholder meetings
UMC participates in and hosts stakeholder meetings that serve as forums for industry, regulators and other stakeholders to discuss the progress of GIDWG projects.