EU New Variations Guidelines to Streamline Lifecycle Management of Medicines

2:25

The aim of the new variations framework is to streamline post-approval change handling, particularly the assessment and processing of variations.

Key takeaways

Scope & purpose

Harmonized rules and procedures for managing Type IA/IB/II variations, with an emphasis on efficiency and fit-for-innovation lifecycle management (including medicines used with medical devices).

When it applies

For variation applications submitted to EMA from 15 January 2026.

What’s coming next

EMA will update the post-authorisation procedural guidance by end-December 2025, to include additional practical details on changes resulting from the new variation guidelines. This will include practical information on regulatory tools detailed in ICH Q12 such as post-authorisation change management protocols (PACMP) and the product lifecycle management document (PLCM).

Who is affected?

Marketing Authorization Holders (MAHs) for medicinal products authorised in the EU via the Centralised Procedure or National Procedures such as the Decentralised and Mutual-Recognition Procedure should be aware of the updated legislation and guidance.

How QbD Group can support

Conduct a focused review of SOPs

pending change controls and planned submissions to ensure alignment with the requirements detailed in the new framework.

Author Variation submissions

We can offer comprehensive post-approval support, starting from analysis of the initial change control, to preparation and review of documentation, eCTD publishing, submission and approval.

Provide training

training on the application of the new framework, covering key changes to grouping, worksharing, classification of changes, updated document requirements and consequential impacts to regulatory strategy. Other complimentary changes can be covered, such as implementation of the Product Lifecycle Management (PLM) Portal.

If you are looking for comprehensive Regulatory Intelligence support that monitors changes to key legislation and guidance, please don’t hesitate to get in touch with one of our experts today!

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