he International Organization for Standardization (ISO) developed a suite of five standards for the Identification of Medicinal Products (IDMP) to internationally harmonize specifications for the identification, description, and exchange of medicinal products between regulatory agencies and biopharmaceutical companies. These standards support the global regulatory activities related to the lifecycle management of medicinal products. When fully implemented globally, the standards, and specifically Pharmaceutical Product Identification (PhPID), will facilitate the unique identification of medicinal products in the context of pharmacovigilance, drug shortages, and the safety of medications (and patients who take them) throughout the world.

In 2019, the World Health Organization (WHO) hosted an international workshop in Geneva focused on the status of IDMP implementation, IDMP substance databases, and differences and challenges in the implementation of IDMP across various geographic regions. The workshop was attended by representatives from Brazil Agência Nacional de Vigilância Sanitária (ANVISA), European Medicines Agency (EMA), Health Canada, Japan Pharmaceuticals and Medical Devices Agency (PMDA), United States Food and Drug Administration (US FDA), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and Uppsala Monitoring Centre (UMC), as well as representatives from Morocco, Nigeria, and Thailand. Some key actions and recommendations from the workshop included:

• Establish a working group for the development of a framework for global implementation and maintenance of PhPIDs.
• Conduct pilot projects and develop a business case for WHO-UMC to be the maintenance organization for global identifiers.
• Develop detail on the use cases (hypothetical examples) demonstrating the benefits of global IDMP, specifically the PhPID.
• The PhPID maintenance framework should follow the pace of the development and availability of the IDMP standards for global use.

Based on the action from the 2019 WHO workshop, The Global IDMP Working Group (GIDWG) was organized and chartered. The GIDWG is an international group with a mission to conduct and report on projects leading to the establishment of a framework for the global implementation of the ISO IDMP standards and maintenance of global identifiers and systems. Founding members include EMA, the US FDA, and UMC. Regulatory agency members include ANVISA, Health Canada, the Saudi Food and Drug Authority (SFDA), and Swissmedic, as well as the industry organization, IFPMA. Several organizations contribute experts, such as the European Directorate for the Quality of Medicines & Healthcare (EDQM), US National Cancer Institute Enterprise Vocabulary Services (NCI EVS), and the WHO. In addition, GIDWG collaborates with ISO Technical Committee 215 Working Group 6 (ISO WG 6) and HL7 to propose, test, and report on solutions to issues that could impede the regulatory implementation and use of the IDMP standards.

In 2022, following the 2019 WHO workshop recommendations, the GIDWG initiated five projects designed to identify and develop consensus on processes, best practices, and operating models for the maintenance of global identifiers for marketed medicinal products and to demonstrate whether the IDMP standards can be implemented globally enhancing public health safety. The goals across the five projects were to:

1. Harmonize and define the capture of standardized information for global
   1. substance identification
   2. dose form identification
   3. strength definitions
2. Define the operating model for global PhPIDs, including business rules for PhPID generation, and a framework for the maintenance of the global identifiers.
3. Participate in the development, verification, international review, and acceptance of HL7 Fast Healthcare Interoperability Resources (FHIR) for successful exchange of medicinal product and substance information.

The GIDWG worked with dose form terminologies and medicinal product information from different regulatory authorities, including ANVISA, the Belgium Federal Agency for Medicines and Health, Finland, Health Canada, Norway, Swissmedic, and the US FDA. The results of the projects demonstrated challenges with the ISO IDMP standards, and thus challenges with their implementation on a global scale. GIDWG experts developed a set of technical and scientific rules to be applied when using the standards to generate a global PhPID. In addition, GIDWG provided recommendations to ISO WG 6 for updates to the substance, dose form, and PhPID standards. These recommendations are under active consideration as the standards are, as of this publication, being revised.

An action item from the 2019 WHO workshop was to develop several use cases or hypothetical examples to demonstrate the benefits of global IDMP, and specifically the PhPID. Until 2023, there were no use cases demonstrating the value of global IDMP using actual medicinal product data. In 2023, the GIDWG launched demonstration use cases for global pharmacovigilance, drug shortages, and cross-border healthcare. Although, as noted previously, there are challenges with global implementation until scientific rules are agreed upon and the standards are revised, it is important to conduct the demonstrations so that the global identifier maintenance framework can keep pace with the development and availability of the IDMP standards for global implementation. In 2024, GIDWG will complete the demonstration use cases, prepare findings, and report at the Fall GIDWG Technical and Stakeholder Meeting hosted by ANVISA in São Paulo.

In summary, the Global IDMP Working Group (GIDWG) is paving the way for a significant leap forward in global public health safety. We are confident that the standards will increase clarity and efficiency in communications about medicines and provide greater certainty to patients no matter where they are.

By establishing a standardized framework for identifying medicinal products, the GIDWG can dramatically improve:

• Drug Safety: Consistent global identifiers (PhPIDs) will streamline pharmacovigilance efforts, allowing for faster and more accurate identification of adverse drug reactions and product issues.
• Drug Shortages: A unified system can enhance global visibility into drug supplies, enabling proactive measures to address potential shortages and ensure that patients receive critical medications.
• Cross-Border Healthcare: Standardized identifiers will facilitate the safe and efficient exchange of medical information across borders, improving patient care and continuity of treatment.

The upcoming completion of GIDWG’s use case demonstrations in 2024 is a crucial milestone, along with parallel updates to the standards. Widespread adoption of the proposed framework, coupled with strong regulatory support, has the potential to revolutionize how medicinal products are tracked and managed worldwide. This collaborative effort between regulators, industry experts, and healthcare professionals represents a significant investment in a safer, more efficient global healthcare system.

Read part 1, part 2, or part 3 of this series in our previous issue.