What is IDMP?
IDMP (Identification of Medicinal Products), is a suite of five standards developed within the International Organization for Standardization (ISO) to facilitate the unique identification of medicinal products in the context of pharmacovigilance and the safety of medications throughout the world.
What are the IDMP Five Standards?
- Medicinal Product Identification (MPID)
ISO 11615: Data elements and structures for unique identification and exchange of regulated medicinal product information. MPID describes the detailed data elements and their structural relationships required for the unique identification of regulated medicinal products.
- Pharmaceutical Product Identifier (PhPID)
ISO 11616: Data elements and structures for unique identification and exchange of regulated pharmaceutical product information. PhPID uniquely associates medical products with the same or similar pharmaceutical composition based on the following data elements: substances, strengths, reference strengths, and dosage form.
- Substance Identification (SubID)
ISO 11238: Data elements and structures for unique identification and exchange of regulated information on substances. Defines substances that constitute a medicinal product by their main, general characteristics.
- Dosage Form and Route of Administration
ISO 11239: Data elements and structures for unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging.
- Units of Measurement (UoM)
ISO 11240: Data elements and structures for unique identification and exchange of units of measurement. Specifies rules for the usage of units of measurement, establishes requirements to provide for traceability to international metrological standards, defines requirements for representation of units of measurement in coded form, provides structures and rules for mapping between different unit vocabularies and language translations.
Ready for Future Growth
As a hosted solution on our secure validated cloud, LifeSphere IDMP adapts over time to support your journey through continued xEVMPD compliance, multiple phases of IDMP compliance, UDI and beyond.
Simplifying IDMP Compliance
LifeSphere IDMP simplifies the compliance process by delivering a single source of truth for all medicinal product information in IDMP, xEVMPD, and other formats, and it comes with built-in business validation rules.
Is There a Timeline for IDMP Compliance?
According to the EMA (European Medicines Agency), they will be the first major health agency to mandate IDMP compliance, with the FDA (U.S. Food and Drug Administration) expected to make the mandate as well.
Pharma companies and organizations face a rapidly shortening window to prepare for this full transition of regulatory data and regulatory systems to adhere to with this complex IDMP compliance mandate.
What Are Some Common Benefits of LifeSphere IDMP?
With LifeSphere IDMP, you will be able to easily improve efficiency, productivity and cost savings.
Below are some of our benefits of our IDMP:
- Seamless Integration with Existing Systems: The open architecture of LifeSphere IDMP makes it easy to link source systems with IDMP data.
- Simple, Easy-to-Learn Interface: Designed to be easy and intuitive to use, with an interface designed for users of all skill levels.
- Pre-Validated Cloud Updates: LifeSphere IDMP provides seamless, pre-validated cloud updates to the latest functionality, insulating companies from changing requirements and avoiding disruption to their validated environment.
- Worry-Free Implementation: Fast, knowledgeable teams adhere to industry best practices to get up and running quickly.
- No Extensive Training Required: Designed to be easy and intuitive to use, with an interface designed for users of all skill levels.
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80% potential efficiency gains driven by our Nava cognitive computing engine
30% immediate cost savings potential via our advanced automation capabilities
100% compliance with all present and upcoming regulatory standards