The European Medicines Agency (EMA) has outlined an extensive programme of revisions to the EU Good Pharmacovigilance Practices (EU GVP) to be implemented throughout 2026.

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These revisions will be implemented across the year and may be subject to public consultation depending on the module.

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Overall, these revisions are intended to update the EU pharmacovigilance framework in line with ongoing EU legislative developments, namely the Implementing Regulation (EU) 2025/1466, and to maintain alignment with ICH guidance. They are also expected to enhance clarity and consistency across the EU GVP modules as the changes are implemented throughout 2026.

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As always, Owlpharma will be paying close attention to the guideline updates and sharing relevant insights with our clients. Stay tuned!

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