22 September 2025
EMA: New variations guidelines to streamline lifecycle management of medicines
The European Commission has published a new Variations Guideline, which streamlines the lifecycle management of medicines. These Guidelines were developed with support from the European Medicines Agency (EMA) and the European Medicines Regulatory Network and will facilitate quicker and more efficient processing of variations which benefit both marketing authorization holders and regulatory authorities. The guidelines will apply to variation applications submitted by marketing authorisation holders to EMA from 15 January 2026.
For more information, see here.
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