Global IDMP Working Group Public Stakeholder Meeting
Uppsala Monitoring Centre
US Food & Drug Administration
European Medicines Agency
n September, São Paulo, Brazil, became the focal point of global discussions around healthcare standards through a series of Global IDMP Working Group (GIDWG) meetings, including a public stakeholder meeting co-hosted by the Brazilian Health Regulatory Agency (ANVISA) and the Uppsala Monitoring Centre (UMC). With IDMP (Identification of Medicinal Products) set to revolutionize global pharmacovigilance, reduce drug shortages, and streamline cross-border healthcare, these discussions served as a vital platform to explore the potential of these standards. It became clear that many challenges remain and that numerous issues must be resolved before IDMP is deployed globally.
The GIDWG is an international collaborative body focused on the global implementation and harmonization of IDMP standards. The founding members are the European Medicines Agency (EMA), US Food & Drug Administration (US FDA), and UMC.
This public stakeholder meeting, part of ongoing efforts to globally implement the IDMP standards, brought together the UMC, World Health Organization, and health authorities ANVISA, El Salvador National Directorate of Medicines, EMA, Health Canada, Norwegian Medical Products Agency, Swissmedic, and FDA, plus industry representation from the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). It followed two days of in-depth technical discussions on key aspects of IDMP implementation, including how to globally harmonize medicinal product attributes such as substance, dose form, and strength, and how to establish the global Pharmaceutical Product Identifier (PhPID) framework for generation and maintenance.
LATAM Perspectives: ANVISA’s Vision for IDMP Adoption
Latin America’s (LATAM’s) representative ANVISA highlighted Brazil’s commitment to adopting IDMP and positioning the country as a regional leader in this area. ANVISA emphasized the pressing need for standardization to address key issues such as drug shortages, product inconsistencies, and counterfeit medicines. The regulator pointed out that Brazil’s healthcare system—and by extension, those of its neighbors—stands to benefit immensely from IDMP’s ability to provide a unified, traceable framework for medicinal products.
ANVISA’s remarks underscored the complexity of managing a fragmented healthcare market where regulatory practices vary significantly across the continent. However, Brazil’s proactive stance on IDMP provides a model for other LATAM countries to follow, with ANVISA pushing to ensure that this global harmonization will close gaps in patient safety and product traceability in the region.
Industry Perspectives: Navigating IDMP Challenges in LATAM
Pharmaceutical industry leaders also discussed the challenges and opportunities of adopting IDMP standards in Latin America. While IDMP holds the promise of streamlining market access and improving product traceability, the region faces significant hurdles in its implementation, as illustrated below.
Key Challenges: Understanding, Data, and Readiness
It is evident that initial information sessions, led by industry associations and ANVISA, have not fully bridged the knowledge gap because many local companies still lack a clear understanding of IDMP standards. Data quality is another major concern, with many organizations struggling with inconsistent local data and the absence of master data systems. Data silos, fragmented across functions, further complicate efforts to harmonize product information.
Additionally, industry readiness is low, with most companies yet to begin implementing IDMP, largely because there’s no legal trigger requiring compliance. This hesitation is compounded by the significant investment needed and the lack of a clear roadmap to guide companies through the transition. Without a data-driven culture or framework, many companies are missing the internal benefits of IDMP beyond regulatory compliance.
Enablers and Opportunities
To overcome these challenges, conducting a gap analysis can help organizations identify specific areas for improvement. Industry education and experience-sharing through trade associations such as IFPMA can also raise awareness of IDMP’s importance.
Linking IDMP adoption to local incentives, such as financing from the Brazilian Development Bank (BNDES), and the Brazilian international patient summary initiative, can make investments more appealing. Collaborating with international experts and integrating IDMP with existing regulatory systems such as WHODrug and eCTD can also streamline the process.
Finally, developing a transparent roadmap and fostering regional collaboration through forums like MercoSur and PAHO can help guide local companies through incremental improvements and make their IDMP implementation more feasible and effective. With the right support and incentives, IDMP can transform regulatory efficiency and product safety throughout Latin America.
Standardization of Substance, Dose Form, and Strength
The core of IDMP standards is the harmonization of key medicinal product attributes: substance, dose form, and strength. These three elements form the foundation of how products are identified, tracked, and monitored across borders.
Substance Identification and GSID Success
Implementation of the Global Substance Identifier (GSID) was one of the most discussed aspects during the São Paulo meetings. Participants were keen to share the successes of the recent End-to-End testing, which involved nearly 3,000 medicinal products and revealed that 96% of substances across regions were successfully assigned a GSID, showcasing the system’s ability to harmonize substance definitions globally.
This result is a significant step forward in addressing one of the most challenging issues in global healthcare: inconsistent substance identification across regions. GSID provides a unified, globally accepted approach to substance identification, allowing healthcare professionals and regulators to refer to the same active ingredient in a consistent way, regardless of local naming conventions.
Dose Form and PhPID Generation
Another major topic of discussion was the Global Dose Form Identifier (DFID), which ensures that medicinal products are correctly categorized based on their form and method of administration. The European Directorate for the Quality of Medicines & HealthCare (EDQM) attributes that guide PhPID generation—Basic Administrable Dose Form (BDF), Administration Method (AME), Release Characteristics (RCA), and Intended Site (ISI)—were key in creating unique identifiers for products during the testing.
This level of detail ensures that similar products can be identified, for example, so that a dispersible tablet can be compared and exchanged for a chewable tablet when needed. Discussions revealed that further refining these attributes will be essential for meeting the unique regulatory needs of different jurisdictions, but the overall progress has been strong.
Strength Harmonization and the Strength Pattern Framework
The strength pattern framework addresses global discrepancies in strength expression by providing consistent methods to represent concentration, presentation, and complex formulations. Although most products passed testing, some challenges—such as products requiring dilution—will require additional refinement. The strength pattern framework ensures that the strength of medicinal products is expressed consistently worldwide. Given the regional differences in units and rounding conventions, this framework is essential for ensuring that dosage strength is clear and accurate across all borders. The framework covers everything from concentration-based strength (e.g., mg/mL) to presentation-based strength (e.g., mg/tablet) and more complex forms like rate-based strengths for patches and infusion pumps.
One of the key outcomes shared during the meeting was the framework’s ability to harmonize unit conversions and strength rounding. Different regulatory bodies around the world may have varying standards for rounding the strength of medicinal products. For instance, one region might round the strength of an injectable solution to two decimal places (e.g., 0.98 mg/mL), while another region rounds to the nearest whole number (e.g., 1 mg/mL). These discrepancies can create inconsistencies in how the product’s strength is represented and interpreted. The End-to-End testing demonstrated that while most products were successfully harmonized, there are still exceptions; for example, varying ratios of substances within mixtures make it difficult to consistently determine the strength of the mixture. In this example, a business / scientific rule would be to assign a default strength value for mixtures with variable ratios and flag them for manual review, to ensure that product strength is consistent across all product types and regions.
PhPID Framework: Business Rules and the Global PhPID Publish Service
The meeting also provided a demonstration of the Global PhPID Publish system, which aims to provide open, real-time access to Pharmaceutical Product Identifier (PhPID) data for regulatory bodies, manufacturers, and healthcare providers. By making PhPIDs readily available, the initiative will improve global transparency and ensure that product information remains consistent and up to date across jurisdictions.
Business rules governing PhPID generation, which define how PhPIDs are assigned based on specific product attributes, are the backbone of ensuring accurate product tracking and identification in a globalized healthcare system. With 90% of products successfully assigned a PhPID during the testing phase, confidence is high that these identifiers will facilitate product management across regulatory environments. This testing phase also proved that the HL7 FHIR technology can support PhPIDs for global use cases (as per submitted scenarios) and use its inherent extension mechanism to allow for requirements beyond those tested.
End-to-End Testing: Proving IDMP’s Readiness for Global Implementation
A major highlight of the meeting was the presentation of results from the End-to-End testing phase. Covering five regulatory data sets from around the world, the testing validated the readiness of IDMP for global adoption. With 96% of GSIDs and 90% of PhPIDs successfully assigned, the data proved that IDMP can handle the complexities of global healthcare systems.
Data Quality and Interoperability
The testing confirmed high levels of accuracy and completeness, providing a solid foundation for regulatory bodies to move forward with IDMP adoption. One of the key takeaways was the ability to track and identify medicinal products consistently across regions—a critical component of ensuring global patient safety.
Stakeholder Feedback
Both regulators and industry participants expressed strong confidence in the system, while also acknowledging that the transition to full IDMP adoption will require continued collaboration. Operational challenges—such as integrating legacy systems and refining business rules for certain products—were identified as ongoing workstreams, but the overall sentiment was optimistic.
A Path Forward for Global Healthcare
The GIDWG Public Meeting in São Paulo demonstrated the important role that IDMP standards will play in advancing global healthcare. As both regulators and industry continue to refine their processes and collaborate on global implementation, the future of IDMP looks promising. By ensuring product safety, traceability, and regulatory efficiency, IDMP is set to transform healthcare worldwide, bringing more consistency and reliability to the management of medicinal products on a global scale.