IDMP – What you need to know

New regulations for the identification of medicinal products are currently being actively developed by the EMA, the FDA and very likely also by other authorities: In accordance with Article 57 (2) of Regulation (EC) No. 726/2004 and Article 40 of Commission Implementing Regulation 520/2012, the European Commission agreed to the introduction of ISO IDMP (Identification of Medicinal Products) data standards on 1 July 2016 as a regulatory electronic exchange format for product information for all medicinal products approved in Europe (CP, MRP, DCP or NP).

In June 2017 the first two Implementation Guides for implementing the ISO IDMP data standards were published and became effective. These guides are the implementation guide for organisational characteristics of the marketing authorisation holder (OMS – Organisation Management Service) and the implementation guide for the terminology lists of the EMA (RMS– Referential Management Services), also referred to as controlled vocabularies.

The background of the IDMP

The joint database is intended to facilitate the identification of medicinal products and active substances. This is important for pharmacovigilance and regulatory activities associated with medicinal products, e.g. to bundle together adverse event reports from across Europe and thus to reduce the response times for medicinal product monitoring.

Pharmaceutical companies in Europe are obliged to implement these statutory regulations and will be affected by a gradual introduction that will entail a considerable, if not a very considerable, commitment (depending on the number of existing medicinal products).

The EMA has been working very hard since 2015 on the shift from the preparatory phase to the transition phase for IDMP. At the start the implementation guides for OMS and RMS were published by June 2017.

The two other implementation guides for Substance Management Service and Product Management Service will be published in mid 2018 according to current planning by the EMA as of February 2017. In the subsequent course of the transition phase, companies are expected to make extensive electronic transfers to the EMA of their product data in four steps over several years (2018–2024).

orangeglobal and IDMP

So that the elaborate implementation of the standard requirements can be more efficiently organised for companies, orangeglobal, as an experienced partner in the area of pharmacovigilance and regulatory affairs, has developed a process that ensures full compliance with the new ISO IDMP specifications. Our full service package is made up of four consultation building blocks:

1. IDMP – fit/gap analysis and strategic planning

  • As-is and requirements analysis regarding the gathering and processing of (old) data
  • Analysing the existing IT infrastructure
  • Analysing customer requirements vs. ISO IDMP requirements
  • Determining the likely volume of work (Master Data Management)
  • Defining the regulatory strategy and implementation strategy
  • Defining responsibilities and process and project management

2. Technical consulting with our partner Extedo

  • Determining the existing IT infrastructure
  • Defining company-wide IT strategy
  • Preparing optimal software solutions
  • Power user training

3. Master Data Management services

  • Data collection, data mapping and data extraction of the required active ingredient and
    • medicinal product attributes as well as the organisation and regulatory data
  • Data processing and coding (MedDRA, GInAS, EDQM) of the IDMP
  • Quality check and data validation of the IDMP

4. Compliance management and maintenance

  • Data migration and data transfer to the EMA
  • Data maintenance and data governance for submitted product data
  • Update service for future ISO IDMP requirements

Over the past few years we have already gained considerable experience with XEVMPD with our customers. IDMP exceeds the complexity of XEVMPD by four or five times.

We help you with a secure and uncomplicated full service package to ensure ISO IDMP compliance, including the option of professional data processing.

We take care of data mapping, data extraction, data processing and coding as part of our ‘software as a service’ solution.

The full data set for each medicinal product is made available to you in the format you require. As a result, you save not only the costs but also the considerable time investment required for purchasing and implementing a software solution while still benefiting from using a professional solution and achieving full compliance.

You receive:

  • Complete, error-free data sets ready for transmission 
  • Data that can be used for other processes in your business
  • The assurance that your data is available in a consistent format (elimination of inconsistencies)
  • The assurance that legal requirements are met
  • As a follow-up, completion of the data within the specified deadlines
  • ISO IDMP compliance


YOUR CONTACT PERSON:



Frau Dipl. Biol. Jana Wolkow
Project Manager Regulatory Affairs
Tel. +49 (0) 731 954 95 - 511
jana.wolkow@orangeglobal.(.)de