Ennov IDMP

Ennov IDMP is a dedicated data management solution designed to help life sciences organisations centralise, govern, and maintain medicinal product data in line with ISO Identification of Medicinal Products (IDMP) standards. Built for Regulatory Affairs teams, Regulatory Operations, and IDMP programme owners, it addresses the significant challenge of capturing and managing the substantially increased volume of regulatory data required under the new IDMP framework. With key EMA deadlines in June and December 2026, Ennov IDMP provides the structure and tooling needed to make IDMP readiness an ongoing, repeatable process rather than a one-time project.

The solution supports the full scope of IDMP data management — from initial data inventory and cleansing through to structured governance, controlled updates, and downstream regulatory execution. For organisations not currently using Ennov RIM, Ennov also offers IDMP EASI, a RIM-agnostic option that supports IDMP compliance and PMS enrichment while working alongside any existing RIM system.

Core Capabilities

• Centralise IDMP data and standardise product definitions across the portfolio
• Align data with EMA expectations, including PMS readiness and improved data quality
• Use of available controlled vocabularies, including EMA SPOR Referentials lists
• Assistance with data extract, cleansing, and migration
• Pragmatic IDMP data management designed to reduce time and effort
• Increased data quality and integrity through governed workflows and controlled updates
• Reduction of duplication across product data through structured ownership and traceability

Key Features

• Metadata orientation for consistent data structuring across products and markets
• Highly configurable platform that adapts as SPOR data services specifications evolve
• Information tracking to maintain audit-readiness as requirements change
• Seamless integration with the Ennov Regulatory Suite, including Ennov Doc, Ennov RIM, Ennov Dossier, Ennov Report, and REST API
• Robust reporting and analytics to support regulatory decision-making
• Each data element flagged with an IDMP Term indicator aligned to EMA SPOR controlled vocabularies

IDMP Readiness Assessment Service

• Ennov offers an IDMP Readiness Assessment as a structured first step in preparing for IDMP submissions
• The assessment produces a documented evaluation identifying all relevant data sources, both structured and unstructured
• Gaps are identified and accounted for, providing a clear roadmap to achieve IDMP compliance
• Supports data inventory, cleansing, mapping to a structured model, enrichment, validation, and ongoing governance

IDMP Submission Workflow

1. Select the scope of the IDMP submission
2. Generate the regulatory message
3. Review changes to product data
4. Validate the submission content
5. Submit to the relevant authority

Why Choose Ennov

• Over 25 years of experience providing software solutions for life sciences, with 450+ life sciences customers
• Over 500,000 users trust Ennov across its platform
• 100% web-based, modern architecture with a user-centric design and high scalability
• 98.5% of projects delivered on time and within budget
• Available as cloud-based or on-premises deployment, with the ability to switch between options at any time
• System configuration and management require no IT skills, enabling full team autonomy
• Single-tenancy architecture minimises business interruptions; data can be hosted locally for total flexibility
• ISO 9001 and ISO 27001 certified

Ennov IDMP is a key component of the broader Ennov Regulatory Suite, which spans the entire regulatory product lifecycle from registration planning through to product retirement. The platform's flexibility ensures that as EMA SPOR data services specifications evolve, updates are systematically incorporated into the solution, keeping organisations continuously aligned with regulatory expectations.