The Identification of Medicinal Products1 (IDMP) initiative from the ISO continues to progress and take shape, with timelines starting to firm up. While there is still much work to be done, agencies such as the EMA have already taken several concrete steps to help organizations prepare for IDMP.
In this Executive Brief, Phlexglobal’s regulatory and technology experts examine the latest major development from the EMA: The February 2020 release of version 1 of the IDMP Product Management Services Implementation Guide2 (“EU IG v1”) for the submission of data on medicinal products.
Based on careful analysis of the implementation guide and our experience successfully managing hundreds of compliance projects worldwide, we provide practical recommendations and real-world use cases to help Marketing Authorization Holders in the EU and EEA streamline their preparations for IDMP.
The recommendations and guidance in this brief are also informed by Phlexglobal’s active involvement in the relevant agency working groups, as well as our comprehensive support helping some of the world’s largest pharmaceutical companies prepare for IDMP.