Navigating IDMP Through The Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)

By Lalith Mohan Tummalapalli, Regulatory Affairs Manager, Regulatory Affairs & Drug Development Solutions, IQVIA; Amar Tandon, Associate Director Regulatory Affairs, Regulatory Affairs & Drug Development Solutions, IQVIA; and Ankit Tyagi, Associate Director, Regulatory Affairs, Labeling Operation, IQVIA

In the fast-paced and interconnected global pharmaceutical industry, establishing harmonized standards for product identification and information exchange is crucial. Marketing-authorization holders (MAHs) are legally obligated to provide and maintain up-to-date information on their medicinal products with the European Medicines Agency (EMA) through Identification of Medicinal Products (IDMP) submissions, following recent regulatory mandates. IDMP, a comprehensive framework consisting of five ISO standards, was designed to uniquely identify and describe medicinal products using consistent documentation and terminologies.

Under EU pharmaceutical legislation, specifically Article 57(2) of Regulation 726/2004, MAHs in the European Union (EU) and European Economic Area (EEA) are required to submit detailed information to the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) to ensure data quality for both authorized and investigational medicinal products. This submission, made through the EudraVigilance Database Management System Web Interface (EVWEB) or the Regulatory Information Management System (RIMS), currently follows the Extended EudraVigilance Product Report Message (XEVPRM) format. However, this format is anticipated to transition to the ISO IDMP-compatible format as the EMA implements the new standards.

Navigating the complexities of IDMP implementation and adhering to these evolving requirements are essential for MAHs to ensure compliance and maintain accurate product information.