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.
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.
The ISO-IDMP standard contains these five standards that provide structure to data elements:
The IDMP is a standard, but not just any standard. It is:
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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