{"id":48500,"date":"2022-07-07T15:18:46","date_gmt":"2022-07-07T15:18:46","guid":{"rendered":"https:\/\/www.arisglobal.com\/?p=48500"},"modified":"2024-09-16T18:01:43","modified_gmt":"2024-09-16T18:01:43","slug":"what-is-idmp-what-it-means","status":"publish","type":"post","link":"https:\/\/www.arisglobal.com\/blogs\/what-is-idmp-what-it-means\/","title":{"rendered":"IDMP: How Did We Get Here, and What Does That Mean for Me?"},"content":{"rendered":"

Identification of Medical Products (IDMP) has been harmonizing data globally across the drug development lifecycle<\/a> since 2003. At its core, IDMP uniquely identifies pharmaceutical products and standardizes product information using five international ISO standards to maintain global compliance<\/a>. For strategic pharmaceutical companies, IDMP can be leveraged beyond that to act as an information and data tool to drive additional value.<\/p>\n

We will explore what IDMP is<\/a>, how it has evolved, and what considerations should be made to be successful in your implementation.<\/p>\n

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The Evolution of IDMP<\/h2>\n

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IDMP began as part of the ICH M5 draft guidance in 2003. The original purpose of the ICH M5 was the standardization of medicinal product identifiers and related terminology to \u201charmonize product information that would facilitate the electronic exchange of individual case safety reports (ICSRs) within and across ICH regions using the ICH E2B format in post-marketing pharmacovigilance.\u201d<\/p>\n

In laymen’s terms\u2014under IDMP regulations, all pharmaceutical and biotech companies are required to electronically submit and maintain detailed product data for all products marketed in Europe.<\/strong><\/em><\/p>\n

Between 2003 and 2007, the ICH M5 released updates to include medicinal product identifiers, lists of controlled vocabularies for routes of administration and units of measurement, and electronic specifications that would \u201cenable wider interoperability across regulatory and healthcare communities.\u201d The M5 draft guideline was submitted to the International Organization for Standardization (ISO) in February 2007.<\/p>\n

Several standards development organizations (SDOs) took part in a joint initiative with ICH, including Health Level 7 (HL7), culminating in five international standards for IDMP<\/a> being finalized and published by ISO in November of 2012.<\/p>\n

The five standards for IDMP are:<\/p>\n