Well, it’s finally here. Pen has been put to paper, or should we say “keys to white space”? The ISO Health Informatics Committee has distributed working drafts of Implementation Guides related to IDMP (Identification of Medicinal Products) to industry working groups. There are 3 documents, each relating to 3 of the existing 5 ISO IDMP standards. The three that have been distributed are:
- ISO 11615 (Medicinal Product Information)
- ISO 11616 (Pharmaceutical Product Information)
- ISO 11239 (Dosage forms, units of presentation, route of admin, and packaging)
This is a big first step toward shedding light on a topic that many in the industry have been wondering about:
The European Medicines Agency (EMA) has provided a target of July 2016 for IDMP compliance, yet implementation guidance is sparse.
To this point, for such an important and far-reaching standard, Life Sciences companies have mainly been in the dark concerning what to expect. Now, organizations will have something to react to and begin assessing against in order to prepare their roadmap to compliance.
At HighPoint, we continue to see a lot of traction with R&D groups who are looking to get an early start on determining a pathway toward IDMP readiness. We’ve initiated IDMP Assessment projects with early adopters who have recognized that the best approach to unify and standardize their product data for IDMP is through a master data management (MDM) strategy. As it applies to IDMP, an MDM strategy allows for:
- Flexible data model definition, which can adapt to changes in the standard over time
- Mastering rules, which provide for data discrepancy resolution and data quality processing
- Ease of interfacing, which is extremely important due to the breadth of source systems that will need to be referenced
- Data Distribution, enabling a single, centralized source of truth to provide IDMP information for submission
- Data Governance, allowing for the review of data changes prior to dissemination
For more on the reasons why MDM is a good strategy for IDMP, you can download our whitepaper here.
View our recent webinar with Informatica on IDMP here for additional information from industry experts.
The next time we check in, we’ll look at the benefits the IDMP standard will provide to the industry beyond simply compliance…