We’ve written quite a few times about the new ISO IDMP standards that are set to be released soon. These standards will change the way life science organizations manage drug information and safety throughout the EU.
The European Medicines Agency (EMA) has recently published Version 1 of the EU IDMP Implementation Guide that aims to inform stakeholders about the specification, data elements and associated business rules to help prepare for the implementation of ISO IDMP standards. It reflects current understanding based on ongoing discussions at the SPOR (ISO IDMP) Task Force.
The guide focuses on the processes for agnostics and does not contain information on the process for submission, exchange or validation of medicinal product information. EU IG v2 will contain the operating model for PMS.
While the rules, data and specifications are expected to be stable, they are still officially a version 1.0 release and may be subject to some modifications over the coming months, as all parts of the documentation are subject to development and testing (e.g. Medical Devices, Reference Strengths).
The key for the first version is to promote awareness and transparency of the work of the SPOR Task Force. You can read the full guide here, but here are a few things you can learn:
- The scope, legal basis and implementation of ISO IDMP.
- Guidance on which data fields and business rules must be submitted.
- Technical specifications on structure and format including a description of principles, security, resources, calls, and end-points for the API.
- Guidance on migration between xEVMPD and PMS including backwards compatibility rules.
EMA is currently developing version two ('EU IG v2'), which will provide more information, including the basis for medicinal product data exchange in the EU. Version two is expected to cover maintenance, data quality assurance, data access and export rules and some examples that companies can use for understanding the process.
EXTEDOpulse solutions are the perfect answer to constantly changing regulations and submission formats.