IDMP Implementation in the world

EU Regional IDMP Implementation

Implementation of the ISO IDMP standards in EU is governed by the following specifications:

  • ISO IDMP Implementation Guides (Technical Specifications): Define the technical details on how to implement the standards, such as specific fields, their formats, and business rules describing their use;
  • EU Implementation Guide: Provides guidance on the interpretation of data fields specifically for the EU regulatory environment as well as guidance on the processes for submitting and updating data.

HL7 Messaging Specifications: The Health Level 7 (HL7) Structured Product Label (SPL) standard is a messaging standard for IDMP; i.e., IDMP data could be exchanged in XML based on SPL

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SPOR as the master data for the EU

ISO IDMP as an evolution of the current xEVMPD for Human medicines:

The submission and maintenance of data regarding authorised human medicines in the EU and the European Economic Area (EAA) has been mandatory since July 2012. This is based on a format called xEVPRM (Extended EudraVigilance Product Report Message) which populates the xEVMPD (Extended EudraVigilance Medicinal Product Dictionary). Because of the legal requirements set out in the legislation, the xEVPRM will be replaced by the ISO IDMP format.

ISO IDMP format is an extension of the current information available in the xEVMPD. In addition, some conceptual differences are introduced which will need to be considered whilst performing the data migration.

Master data approach and scope

The approach to implementing the ISO IDMP standards is based on the four domains of master data in pharmaceutical regulatory processes: Substance, Product, Organisations and Referential (SPOR) data.

EMA will establish ISO IDMP compliant business services for the central management of data in each of the four SPOR areas. These include data management services for:

  • Substance Data: Harmonised data and definitions to uniquely identify the ingredients and materials that constitute a medicinal product;
  • Product Data: Harmonised data and definitions to uniquely identify a medicinal product based on regulated information (e.g. marketing authorisation, packaging and medicinal information);
  • Organisation Data: Data that comprises of organisation name and location address data for organisations such as MAH, sponsors, regulatory authority, manufacturers;
  • Referential Data: Lists of terms (controlled vocabularies) used to describe attributes of products e.g. lists of dosage forms, units of measurement, routes of administration.
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