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.