LifeSphere

IDMP Compliance

The IDMP groundwork provides pharma companies with the convenience to improve necessary data processes across the regulatory lifecycle, which will also significantly impact regulatory affairs, operations, pharmacovigilance, data management and more.

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?

    1. 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.

    1. 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.

    1. 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.

    1. 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.

    1. 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.

Innovative Automation

LifeSphere IDMP seamlessly curates, manages, and drives submission data alongside Lifesphere RIMS or alongside your RIMS system. Advanced AI-driven automation creates an agile foundation, allowing teams to quickly adapt to new regulatory requirements.

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.
LifeSphere IDMP Simplifying Compliance
FACT SHEET
Compliance for today. Readiness for tomorrow.

LifeSphere IDMP is a simple-to-use, ISO IDMP cloud application that addresses the
challenges of implementing Identification of Medicinal Products (IDMP) standards.

CHECKLIST

IDMP Readiness Checklist: A Guide to Preparing for the New ISO Standard.

 

With IDMP, every aspect of your organization will be affected: from discovery to post-market authorization, all referentials will need to be uniform.

WHITE PAPER
Regulatory 2025: Developing an Effective 10-Year Strategy for Technology-Enabled Regulatory Transformation

To achieve an objective of regulatory 2025 and beyond, companies will need to harmonize processes and implement a central technology platform. They will need to establish a platform from which the rest of the organization can consolidate data and proactively measure metrics internally.

WEBINAR
Preparing for IDMP now and into the future
IDMP data standards are forcing companies to capture more data than ever before – and effective data management can be time-consuming and costly. Learn how you can get ahead of changing regulations and timelines to increase your compliance agility and minimize expenditure risks. 
PARTNERS

Partnering With the Industry’s Best

Want to Learn More?

Learn more about LifeSphere IDMP

RESULTS

Delivering Real Results to a Global Client Base

80

%

Of Top 50 Biopharmas

80% of the top 50 biopharma companies are our clients

80

%

Efficiency Gains

80% potential efficiency gains driven by our Nava cognitive computing engine

30

%

Cost Savings

30% immediate cost savings potential via our advanced automation capabilities

100

%

Compliance

100% compliance with all present and upcoming regulatory standards