Mastering IDMP Compliance: with 5 Key MDM features

5 Key Features Making MDM the Definitive Solution for IDMP Compliance

Master Data Management (MDM) serves as the foundation for ensuring IDMP compliance and IDMP regulations by providing a robust framework for managing medicinal product data throughout its lifecycle.

Introduction to IDMP Compliance:

The International Organization for Standardization (ISO) has developed the Identification of Medicinal Products (IDMP) standards, which outline standardized definitions for identifying and describing medicinal products intended for human use. These standards are designed to streamline the exchange of medicinal product information in a reliable and consistent manner.

In the pharmaceutical industry, a single finished product can take on three distinct forms:

This illustrates just one aspect of the complexity hence there is a need for a common language throughout the lifecycle of a medicinal product.

IDMP consists of five distinct standards, each of which defines concepts, data elements, and their structural relationships.

The European Medicines Agency (EMA) is implementing the ISO IDMP standards for the identification of medicinal products in a phased programme, based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organization and referential (SPOR) data.

Challenges to IDMP Compliance:

Why is MDM the solution for IDMP?

1. Data Standardization
2. Data Quality Management
3. Version Control and Audit Trail
4. Data Stewardship & Data Governance
5. Single Source of Truth

Curious about how our MDM expertise can help pharmaceutical companies achieve IDMP compliance?

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