PhlexIDMP is a single regulatory database that will help you to avoid redundant data that exists within your submissions. PhlexIDMP is based on two key components: controlled vocabulary management and codes that deliver the best ready to use IDMP management solution.
IDMP stands for the Identification of Medicinal Products and is a general term used when referencing the collection of ISO data standards – ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240 – that are being refined and implemented by regulatory bodies in support of improving pharmacovigilance via the soon-to-be mandatory submission of this data to health authorities.
In comparison to xEVMPD (Extended EudraVigilance Medicinal Product Dictionary), the current legislative format, IDMP is substantially more detailed and complex.
By standardizing the structure and terminology used to describe healthcare products across all markets and all marketing authorization holders (MAH), the impact on health care delivery and patient safety has great potential:
With the EMA expected to be the first health agency to mandate compliance with ISO IDMP (with the FDA not far behind), organizations face a rapidly shortening timeframe to prepare for this the highly complex compliance mandate.
Download Phlexglobal’s latest executive brief, “New Developments in IDMP: What You Need to Know, and What You Can Do Today.” You’ll benefit from our extensive compliance and technology expertise in life sciences, as well as Phlexglobal’s experience helping some of the world’s largest pharmaceutical companies prepare for IDMP.
The challenge for a successful IDMP implementation is the fact that structured data output is required, while the data sources and existing data are typically unstructured. Therefore, a key element for a successful IDMP project will be a comprehensive data source analysis.
HL7 compliant submission publishing format. Publish test submission at any time. Optional push of final IDMP data into your master data management system.
Workflow guided by wizards
Directly connects to external databases such as GSRS, UCUM and EDQM
Edit data at any point in time during submission creation process