Over the past four days, we’ve been sharing highlights of some of the most relevant regulatory updates currently impacting the EU regulatory landscape. As promised, here’s a summary post with all the key changes in one place:
What we covered:
- Revision of the Variation Framework for Medicines
The updated Variations Guideline is expected to be published in the Official Journal of the EU around late August/early September 2025, introducing streamlined procedures and improved clarity. - IRIS – Regulatory Procedure Management
The expansion of IRIS continues, with more regulatory procedures being migrated to the platform. This shift is aimed at greater efficiency and transparency in communication with EMA. - European Shortages Monitoring Platform (ESMP)
The upcoming implementation of ESMP will enhance the monitoring and reporting of medicine shortages across the EU, supporting proactive risk management. - Product Management Service (PMS)
PMS is progressing as a central data repository under the EU IDMP framework, setting the groundwork for greater data standardisation and integration across the regulatory network.
These updates reflect the ongoing evolution of the regulatory environment and the push toward digitalisation, harmonisation, and increased transparency.
Check out the image for the required actions and the full picture!
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