Skip Ribbon Commands
Skip to main content
< BACK

ISO IDMP in Brief

What is IDMP?

IDMP (Identification of Medicinal Products) covers five ISO standards focusing on the structuring of information according to defined information models. Companies with products in the European Union (or companies that are running trials in the European Union) will be required to submit data to the European Medicines Agency (EMA) once the IDMP standards have been implemented.

Why IDMP?

  • Improve pharmacovigilance oversight
  • Traceability of a product through the entire life cycle
  • Transparency of the manufacturers involved in medicinal products
  • Global alignment – standardize the communication between industry and authorities

Marketing Authorization Holders’ IDMP journey

In order to achieve IDMP compliance, a unified, corporate-wide, cross-functional effort is required.
To achieve compliance, it is critical to identify sources across the life cycle as well as to ensure alignment with the specified levels of conformance, defined Controlled Vocabularies (also known as pick lists)
and data formats.

Scope: Data related to…

  • All registered active ingredients & excipients
  • All registered investigational products
  • All registered authorized products
  • All data class groups in the figure to the right:

What are the challenges of implementing IDMP?

The typical challenges that companies face when working to achieve IDMP compliance include

  • Failing to ensure involvement from the line of business
  • Difficult to anchor and obtain funding from business areas
  • Information is scattered across multiple business areas
  • Structuring content from documents
  • Alignment of processes in order to accommodate the new use of data and IT systems
  • Communicating about IDMP to stakeholders

EMA’s Implementation Timeline

 

 

 

 

 

Niels Buch Leander +45 3075 5339nbln@nnit.comManaging Consultanthttps://www.linkedin.com/in/nielsbuchleanderNiels Buch Leander

 

 

ISO IDMP – Five phases towards compliancehttps://www.nnit.com/OfferingsAndArticles/Pages/NNIT_Article_ISO-IDMP_Five-phases-towards-compliance.aspxISO IDMP – Five phases towards compliance
Reflections on a dramatic month for IDMPhttps://www.nnit.com/OfferingsAndArticles/Pages/ReflectionsonadramaticmonthforIDMP.aspxReflections on a dramatic month for IDMP
IDMP: A dramatic June followed by a prosperous Julyhttps://www.nnit.com/OfferingsAndArticles/Pages/IDMPReflectionsJuly.aspxIDMP: A dramatic June followed by a prosperous July
IDMP Acceleratorshttps://www.nnit.com/OfferingsAndArticles/Pages/idmp-accelerators.aspxIDMP Accelerators
ISO IDMP: Another Compliance Project or a new way of Conducting Business?https://www.nnit.com/OfferingsAndArticles/Pages/RF-2016-04-ISO-IDMP.aspxISO IDMP: Another Compliance Project or a new way of Conducting Business?
The Total IDMP Effort – an insight into the data volume of an ISO IDMP submissionhttps://www.nnit.com/OfferingsAndArticles/Pages/Article_The-Total-IDMP-Effort_IPI.aspxThe Total IDMP Effort – an insight into the data volume of an ISO IDMP submission
ISO IDMP business casehttps://www.nnit.com/OfferingsAndArticles/Pages/Datasheet_ISO_IDMP_business_case.aspxISO IDMP business case
NNIT – your preferred implementation partner for IDMPhttps://www.nnit.com/OfferingsAndArticles/Pages/idmp-implementation-partner.aspxNNIT – your preferred implementation partner for IDMP
Is IDMP ≠ MDM?https://www.nnit.com/OfferingsAndArticles/Pages/idmp-mdm.aspxIs IDMP ≠ MDM?
Organizational Change Management for ISO IDMP leveraging the mutual industry challengeshttps://www.nnit.com/OfferingsAndArticles/Pages/ocm-idmp.aspxOrganizational Change Management for ISO IDMP leveraging the mutual industry challenges