IDMP (Identification of Medicinal Products) refers to a set of 5 ISO standards - ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240 (see figure 1) – designed to standardize the structure and terminology used to describe marketed medicinal products. IDMP’s primary goal is to enhance patient safety by improving the speed, accuracy, consistency, and sharing of adverse events and safety signal reporting globally. IDMP will be mandatory worldwide for all Marketing Authorization Holders in ISO countries.
A global initiative, IDMP is being developed through a collaborative effort of multiple health regulatory agencies and associated standards bodies, including ISO, EMA, FDA, PMDA, and HL7. The EMA is expected to be the first health agency to mandate compliance with IDMP. Following is the estimated compliance timeline in EU and EEA countries, based on working group progress and the latest EMA communications, including the June 2021 publication of the EU IDMP Product Management Services Implementation Guide version 2.1.