EMA Establishes Drug Identification Task Force

February 20, 2015
BioPharm International Editors

The agency is enlisting members of European pharmaceutical associations and industry representatives to participate in IDMP task force.

 

The European Medicines Agency (EMA) has gathered representatives from European Union national authorities, software vendors, and other organizations to create a task force that will develop a strategy for the implementation of international standards for the identification of medicinal products (IDMP) in the EU. European pharmacovigilance legislation requires the use of common standards in the EU to identify and exchange information on medicines.

The International Organization for Standardization (ISO) developed IDMP standards to establish data elements, formats, and terminologies for the unique identification of drugs and the exchange of information on medicines, including pharmaceutical dosage forms, routes of administration, packaging, and active substances. The ISO standards were finalized in 2012 and implementation guidelines are expected to be published in 2016. According to EMA, the ISO standards will simplify the exchange of information between international regulatory authorities, therefore supporting the development of electronic health records and improving the safety monitoring of drugs.

Organizations interested in participating in the task force must express their interest to EMA by Mar. 6, 2015.

Source: European Medicines Agency