EMA: Update on the Guideline “Stability Testing for Variations”
The EMA has updated the guideline on stability testing for variations (Revision 3, applicable from 15 January 2026).
The key changes are:
- New variation classification: Transition from the former B-codes to the new Q-codes, in line with the updated EU Variations Guideline.
- Narrowed scope: The guideline now applies only to human medicinal products (CHMP); veterinary products are no longer covered.
- Greater clarity for complex changes: More precise guidance for novel or complex manufacturing processes and for changes affecting sterile products and packaging.
- Stability requirements largely unchanged: The extent and duration of stability data remain essentially the same, but are better structured and aligned with current ICH guidance.
Source:
EMA: Guideline on stability testing for applications for variations to a marketing authorisation
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