Overview

The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). These are a set of common global standards for data elements, formats and terminologies for the unique identification of and the exchange of information on medicines. Once implementation has been fully completed, pharmaceutical companies will be required to submit data on medicines to the EMA in accordance with these standards.

The five ISO standards for IDMP (ISO 11238, 11239, 11240, 11615 and 11616) simplify the exchange of information between regulatory authorities internationally and improve the safety monitoring of medicines by facilitating the assessment of data across classes of medicines and therapeutic areas. ISO finalized the IDMP standards in 2012 and is currently developing implementation guides at international level. Following the implementation of the ISO IDMP standards, the Agency will replace its data-submission format in line with the ISO IDMP standards, terminology and formats.

It is tentatively accepted by European Parliament house to implement IDMP in Europe in multiple Iterations starting with Product information, which includes eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) information and additional fields. However, the official confirmation from the EMA is not yet announced.

Being a specialist provider of Regulatory consulting, operations & technology services, Freyr provides efficient and seamless IDMP implementation for its clients. As part of the solution the following data management software solutions and accelerators are being deployed.

  • IDMP Assessment
  • Data level status reports and analytics in terms of availability, accuracy and integrity
 

Freyr IDMP Expertise

IDMP Assessment

  • Data level status reports and analytics in terms of availability, accuracy and integrity
  • Data Consideration Factors:
    • Availability of data
    • Completeness of the data elements
    • Data compilation status
    • Data submission status
    • Data quality

IDMP Readiness Support Data Management

  • Provide data management strategy and implementation approach
  • Perform IDMP readiness, gap analysis and future state recommendations
  • No need for any technology solution (hosted or on premise)
  • Cost-effective ‘Per- Market Authorization’ or ‘Per-Product’ pricing model

IDMP Software Solution

  • It is intuitive and user-friendly, hosted, on-demand web-based solution that supports authoring, reviewing, approving, publishing, and archival processes with state-of-the-art navigation and user interface components.
  • The software solution offer modular data entry screens based on submission components, enabling granular authoring and component level data entry validation without any dependency on completion of other components.
  • It has an inbuilt function that automatically tracks, captures, and updates any future changes entered.
  • The software solution efficiently monitors, tracks, updates and creates eXtensible Markup Language (XML) files that are compliant with the EMA requirements.
 

Freyr IDMP Features

  • Highly cost-effective secure cloud hosted solution
  • State-of-the-art navigation & user interface
  • Modular component based granular authoring
  • Assured data security from creation to storage
  • Flexible and cost-effective licensing model
  • Record management, audit trail, and automated submission
  • Comprehensive change management integrated with a robust record management system and a unique reports generation capability
  • Dynamic record updates in line with upcoming guidelines to ensure information data currency and timely submission
  • Online Training and Support

 

To Know More about Freyr IDMP and to take a feature-specific comprehensive product tour.

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