Identification of medical products

Perspectives

Identification of Medicinal Products

Connecting the parts

Meeting IDMP requirements is a complex process, with many moving parts. Efficient and effective implementation will require companies to develop a vision and global IDMP strategy to drive alignment, collaboration, and cooperation.

Identification of Medicinal Products (IDMP) is one the biggest regulatory challenges for all pharmaceutical companies operating in Europe. How can companies navigate this journey towards increased patient safety and use it as an opportunity for business transformation?

The building blocks of IDMP implementation

The potential benefits of meeting evolving Identification of Medicinal Product (IDMP) requirements extend far beyond regulatory compliance. Through IDMP implementation, pharmaceutical companies can unlock the power of product data to transform their business and improve patient health. Download the full report to learn more.

Collecting this data is expected to:

  • Link product and safety information across global regulatory agencies
  • Increase the biopharma industry’s signal detection capabilities to quickly identify product risk issues, including recalls
  • Connect critical product information within health care systems
  • Help facilitate the creation of global drug dictionaries and product dossiers
View or download the report
Five standards of IDMP:

What needs to happen and when?

The roll out of IDMP will take an iterative approach, providing the industry with time to comply with the regulatory mandate.

The four iterations for data submission:

  1. Minimum required elements to assign identifiers for marketed products
  2. Full investigational product scope
  3. Remaining requirements for clinical particulars
  4. Remaining requirements for packaging and manufacturing
     

The timeline for IDMP however has been dynamic. While guidelines are expected to be released in 2018, the delay and changes in timing is providing life sciences companies with a window of opportunity to re-evaluate their strategic plans for IDMP, considering the synergies that exist with other regulatory mandates as well as the opportunities for cross functional collaboration and operational efficiency.

IDMP synergies with other regulations

IDMP shares a range of commonalities with other regulatory mandates, and will form the basis as a data standard for many of these future regulations. Considering IDMP as a part of a much larger regulatory landscape of initiatives will allow life sciences companies to leverage commonalities and synergies.

For more information on the synergies of IDMP with other regulations, view or download the full report: Connecting the parts: Developing an integrated IDMP strategy.

Beyond IDMP compliance

IDMP will lay the foundation for building an insight-driven organisation by delivering a standardised cross-functional data model based on regulated product master data and preparing the industry for future excellence.

Companies that go beyond the minimum requirements of IDMP can expect greater operational excellence and efficiency through improved data quality, increased collaboration and integration of technologies.

Developing an integrated and holistic IDMP strategy

A change of this scale generally leads to change in business operating models and IT transformations highlighting the need for an end to end, integrated change process involving these crucial steps:

  1. Understand the regulatory requirements and create awareness 
  2. Understand the impact on business processes and identify any gaps or pain points 
  3. Identify the remediation plan and actions 
  4. Identify and create a strategic vision for implementing the change 
  5. Analyze if people/data/system/processes need to be improved 
  6. Present the business case 
  7. Define implementation strategy based on the vision

IDMP five standards

IDMP is a set of five data standards from the International Organization for Standardization. Under the IDMP standards, pharmaceutical and biotech companies will be required to electronically submit detailed product data and maintain it on an ongoing basis.

Five standards of IDMP

IDMP timeline

The IDMP timeline has been dynamic; in the European Union clarity is starting to emerge. The United States and other markets should expect to see increasing activity over the next few years.  

Becoming IDMP-compliant is expected to drive biopharma organisations to make significant changes to current product-related processes and systems, ushering in a new era of cross-functional collaboration and paving the way for opportunities to generate transformational benefits beyond compliance.

Additionally, the European Medicines Agency (EMA) is engaging in efforts to drive regulatory standardization for core IDMP master data governing Substance, Product, Organization and Referential (SPOR) data, for which a subset will also be expected to be leveraged in other EU directives, further making IDMP implementation critical. This article addresses the challenges and opportunities of IDMP implementation and describes a path forward for biopharma companies.

Learn about how companies can take a first and most crucial step towards achieving IDMP readiness through a thorough and diligent fit-gap analysis.

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