Regulators report on progress toward implementing IDMP

NORTH BETHESDA, MD – Regulators around the globe are making progress in implementing the Identification of Medicinal Products (IDMP) a global set of standards for identifying medicinal products. The EU is at the forefront of these efforts, while other countries, including Switzerland and Canada, are in the early stages of adopting IDMP standards. An EMA official said that mapping their identification data to the IDMP standards has “not been easy.”

A panel of regulators discussed the progress being made in implementing IDMP on Monday during the DIA Regulatory Submissions, Information, and Document Management Forum.

Panelists said the US Food and Drug Administration (FDA) has also made strides in implementing the IDMP, though the agency was not represented at the meeting. According to Reuters, a travel ban was instituted in the early days of the Trump administration that called for US health officials to cancel external engagements that were accepted prior to 20 January 2025.

IDMP is a set of five standards developed by the International Organization for Standardization (ISO) to create a global identification system for identifying all key aspects of a medicinal product. The ISO IDMP standards are intended to improve the accuracy, completeness and consistency of information about medicinal products among international stakeholders.

The five standards are the medicinal product identification (MPID) which covers the product name, clinical particulars, packaging information; the pharmaceutical product identification (PhPID) which covers products with similar pharmaceutical compositions; the substance identification (SubID); the dosage form and route of administration; and units of measurement (UoM) which addresses data elements for the exchange of information on units of measurement.

Nimesh Patel, senior director of regulatory and clinical systems and clinical data operations at Eisai US, stated that these standards enhance patient safety, help prevent drug shortages through better traceability and also facilitates the sharing of medical product information across different jurisdictions.

Mixed implementation progress

Regulators from the EU, Switzerland, and Canada described the progress being made in implementing IDMP in their countries.

Isabel Chícharo, head of regulatory data management at the European Medicines Agency (EMA), said the agency has been “leading the implementation in Europe.” The journey started in 2017 when EMA implemented two of the five standards.

To date, EMA has developed a system to transform legacy product data to the IDMP and has implemented a product management system (PMS) system for the IDMP. EMA has also developed a product user interface and a data analytics platform for the IDMP.

EMA has also published guidance for users to ensure that data can be shared, combined, exchanged, and understood by different users. These include guidance on the ISO EDMP standards, the H7 FHIR standards, which are messaging and exchange standards, and the IDMP implementation guide, which is the basis for submitting and exchanging medicinal product data in the EU.

Chícharo said that IDMP implementation is still a work in progress. She noted that “the journey has not been easy. Transforming the data that we had has had some challenges, particularly in terms of the data quality. We have come a long way but still need to do more work in grouping the products that we have in our systems.”

Other countries, such as Switzerland and Canada, are in the early phases of implementing IDMP.

“We have implemented some aspects of the IDMP standard in our processes and systems. However, we are still far from full implementation,” said Philipp Weyermann, of Swissmedic.

The agency’s journey started as an observer in ICH M5 in 2021 and has been participating in Global IDMP Working Group since 2022.

Weyermann said that work on mapping the dosage forms standard and the substances standard to IDMP is ongoing. So far, 70% of the substances approved in marketing applications have been mapped to the IDMP.

The agency “is committed to ISO IDMP implementation and we see this as part of our digital transformation.”

He added that "we are a small agency, and international collaboration is very important to us."

Similarly, Karin Hay, from Health Canada, said the agency is “in the early stages of IDMP implementation.” The agency has developed a policy framework for data standard requirements and has established the foundation for its gradual implementation.

Health Canada began its journey with IDMP in 2016 by completing the Canadian Clinical Drug Dataset. The agency started mapping existing pharmaceutical and biological substances to the IDMP standard in 2021. In 2022, Health Canada established a data governance network to enhance the use, management, and stewardship of HPFB’s data, including the adoption of IDMP. In 2023, the agency joined the Global IDMP Working Group.

While an FDA official was not at the meeting, information from FDA’s website indicated that many of the terminologies and standards in data submissions had been aligned with IDMP.

“FDA has been using standards and terminologies like the concepts presented in the IDMP standards,” the website states. “We have assessed current standards, operations and systems and determined that many of the terminologies and standards currently used in regulatory submissions across the medical product development lifecycle are compatible with the IDMP data concepts, for example, the U.S. National Drug Code, Unique Ingredient Identifier, and the Unified Code for Units of Measure conform to ISO 11615, ISO 11238, and ISO 11240, respectively.”

In March 2023, FDA issued a final guidance on the implementation and use of ISO IDMP standards. (RELATED: This Week at FDA: Califf’s budget testimony, ISO IDMP guidance, and more, Regulatory Focus 31 March 2023)

Regulators report on progress toward implementing IDMP

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