IDMP in a Nutshell

Intro

Established in 2016 by the European Medicines Agency, the ISO IDMP standard is a regulatory requirement that needs to be implemented by all pharmaceutical companies submitting products by Q1 2023. The EMA expects pharmaceutical companies to be able to submit product information in compliance with ISO IDMP since Q1 in 2022. 

What is the ISO IDMP (Identification of medicinal products) standard?

The International Organization for Standardization (ISO) established IDMP, a group of five standards, to make it easier to identify pharmaceuticals uniquely for pharmacovigilance goals and to ensure the safety of medications worldwide. 

These standards offer a framework for the distinct identification and description of pharmaceutical products with uniform documentation and vocabulary, as well as for sharing product data between regulators, producers, suppliers, and distributors. 

The ISO IDMP standard ensures that data is captured uniformly and aligned with regulatory requirements to support patient safety and operational efficiency goals.

One of the most pressing issues is the transparency and consistency of data used by all industry participants, such as regulators, manufacturers, suppliers, distributors, and other participants along the value chain. Under current regulations, pharmaceutical companies use different terminologies for recording medicinal products, doses, administration routes, or measurement units. Due to the need for cross-functional collaboration across the pharma value chain, there is a substantial need to align vocabularies used in different functions to ensure everybody understands each other's data correctly and effectively. Unifying these vocabularies inside value chains and across organizational boundaries is a crucial goal for implementing IDMP. 

These are the ISO-IDMP components.

The ISO-IDMP standard contains these five standards that provide structure to data elements: 

Medicinal Product Identification (MPID) ISO 11615

• Regulated medicinal product information. MPID describes the detailed data elements and their structural relationships required for the unique identification of regulated medicinal products. MPID includes data elements such as the medicinal product name, product packaging, clinical particulars, and marketing authorization. 

Pharmaceutical Product Identifier (PhPID) ISO 11616

• This standard enables the unique identification and exchange of pharmaceutical products in their generic form. PhPID uniquely associates medical products with the same or similar pharmaceutical composition based on the following data elements: substance, strength (units of measurement/presentation), reference strength, and dosage form.

Substance Identification (SubID) ISO 11238

• Data elements and structures for unique identification and exchange of regulated information on substances. Defines substances that constitute a medicinal product by their primary, general characteristics.

Dosage Form and Route of Administration ISO 11239

• Data elements and structures for unique identification and exchange of regulated information on pharmaceutical dose forms, presentation units, administration routes, and packaging.

Units of Measurement (UoM) ISO 11240

• Data elements and structures for unique identification and exchange of units of measurement. The standard provides specific rules and structures for mapping between different units' vocabularies and language translations. UoM provides traceability to international metrological standards and defines requirements for the representation of units of measurement in coded form.

Conclusion

The IDMP is a standard, but not just any standard. It is:

• A harmonized standard: Because of its widespread use, regulatory bodies like the U.S. Food & Drug Administration Agency require submitting products in coherence with IDMP. The FDA collaborated with the EMA to establish the FDA-EMA IDMP collaboration framework for this matter.
• A long-term standard: As regulatory bodies establish IDMP, its inception is here to stay and can help pharmaceutical companies align their data to enable digital transformation. IDMP is a stepping stone towards becoming a data-driven organization, a necessary step in today's information age. 

Besides the necessity of regulatory compliance, in which IDMP forces all stakeholders to adhere to standardized fields, it also offers excellent opportunities to improve enterprises' approach to dealing with massive amounts of data. 

The ISO IDMP standards offer descriptions specifying data components and their structural linkages that permit the comprehensive description of any medical product worldwide in an organized and unique manner.

ISO IDMP is for more than just medication registration. The standards encompass the whole pharmaceutical product lifecycle, including goods in development, investigational drugs, products under assessment, and approved medications. That is why pharmaceutical companies establishing these standards in their data strategy enable a unified understanding across the entire pharma value chain. IDMP implementation not only decreases compliance risks (and corresponding fees) but also increases the velocity of adopting digital technologies in the value creation process. 

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