Summary of Updates: Version 2.1 of the EMA IDMP Implementation Guide

January 14, 2022

With the ever-changing landscape of RIM system compliance, it’s crucial to remain up to speed with the latest guidelines. In this article, discover the changes from Version 2.1 of the EMA IDMP Implementation Guide (IG) that was published June 30th, 2021.

For an in-depth examination of this update, be sure to download our free Industry Brief that not only outlines these changes, but also provides analysis and solutions that can help pave the path to compliance.

Additions and Modifications of Data Elements

Although a minor IG update was expected, the latest revision to the IDMP data chapter proved rather extensive with the introduction of new data elements as well as changes to existing data elements. Additionally, comprehensive process details were provided. The main takeaways from the Chapter 2 revisions are:

  • The addition of the Genetically Modified Organisms (GMO) field
  • General, editorial, and technical clean-up of the guidance document
  • The Provenance, or reason for sending the IDMP message, was clarified
  • MedDRA and ATC codes can now be used directly without the need for an RMS mapped term

Looking for an analysis of these changes? Get free access to the industry brief: Maintaining Compliance: Adapting to Changing Requirements.

A Solution That Ensures Compliance

The Digital Application Dataset Integration (DADI) is increasingly interconnected with the IDMP (Identification of Medicinal Product). Evidently, these projects are aligning since DADI manages the data related to the procedure, and IDMP manages the data related to the product.

While the details for the next update remains unknown, Ennov RIM/IDMP has consistently responded quickly to new guidance updates. Ennov RIM/IDMP is a scalable, flexible and open platform, meaning it easily adapts to the changing regulatory requirements. For example, since the last two versions of the IDMP IG 2.0 and 2.1, Ennov RIM/IDMP was able to implement these regulatory updates in under 2 months.

While the Ennov platform will continue to incorporate new innovations, Ennov’s current track record should establish confidence that clients’ needs and timelines are met even when unexpected regulatory updates occur.

Share :


Read more posts

Can IDMP Transform Pharma? 

The pharmaceutical industry is no stranger to complex regulations and compliance requirements. Among them, the Identification of Medicinal Products (IDMP) standards set by the European

Read More »

RIM Analytics: Dashboards with a Purpose

Effective Regulatory Information Management involves a constant stream of prioritizations, decision-making, and activity management and monitoring.  Effective management occurs when prioritization is risk-based, decisions are

Read More »

5 Myths About eTMF

Managing eTMF (electronic trial master file) is a challenge. However, some organizations impose burdens upon themselves by following practices that aren’t consistent with Health Authority guidance. In

Read More »

FDA eCTD-Related News

At Ennov’s recent Regulatory User Group meeting, my colleague Steve Clark provided an update on regulatory news covering the last six months.  Our users appreciated

Read More »

Optimize Your eTMF Strategy

I have recently published a peer-reviewed paper called “Optimize Your eTMF Strategy”, that you can read or download on the Journal for Clinical Studies (Volume

Read More »

Risk-Based Monitoring Improved

On July 17th, the FDA and Duke Margolis Center for Health Policy sponsored a workshop entitled “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical

Read More »

Our Journey with Scrum

[Reading time 10-15 minutes] As we approach our first eighteen months of using the Agile Scrum methodology at Ennov PV, it seems a good time

Read More »

Top 5 eTMF Features | etmf systems

Managing essential documentation for clinical trials has become quite complex in today’s clinical research environment. Study sponsors are required to implement a quality system to

Read More »