From standards to impact: building better health for all

The 2025 annual report of the European Directorate for the Quality of Medicines & HealthCare comes to you exclusively online. All the essential information on our organisation’s activities and efforts to further public health protection in Europe and beyond is now only a few clicks away.

Delivering impact through
partnership and innovation

Hear from Petra Doerr, EDQM Director, on this year's report.

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EDQM facts and figures for 2025

Our impact in public health protection.

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Tackling public health challenges

Addressing emerging needs and supporting the safety, quality and accessibility of medicines and health products

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Global impact - Global trust

For the EDQM, global impact and global trust are inseparable.

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Strengthening collaboration with stakeholders

Public health challenges are global and require sustained co-operation, trust and shared expertise.

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Science by the EDQM

Our contributions to scientific articles in 2025.

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Table of abbreviations

Abbreviations used in our annual report.

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Guideline/document de recommandation	Statut	*Commentaire*
Annexe IV de « Qualification of Equipment » – « Qualification of IR Spectrophotometers »	achevé	passé en revue
« Management of Reagents »	achevé	passé en revue
Annexe VI de « Qualification of Equipment » – « Qualification of Piston Operated Volumetric Apparatus (POVA) »	en cours	révision
Annexe XI de « Qualification of Equipment » – « Qualification of Analytical Columns »	en cours	révision
Annexe VII de « Qualification of Equipment » – « Qualification of Mass Spectrometers »	en cours	révision
Annexe 3.4 de « Evaluation and Reporting of Results » – « Verification of Out-Of-Specification Results in Animal Testing »	en cours	révision
Annexe 4 de « Evaluation of Measurement Uncertainty » – « Estimation of the Measurement uncertainty for the Biological Methods »	en cours	nouveau texte

Guideline/Recommendation documents	Status	Comment
Annex IV to Qualification of Equipment – Qualification of IR Spectrophotometers	Finalised	Reviewed
Management of Reagents	Finalised	Reviewed
Annex VI to Qualification of Equipment – Qualification of Piston Operated Volumetric Apparatus (POVA)	In progress	Revision
Annex XI to Qualification of Equipment – Qualification of Analytical Columns	In progress	Revision
Annex VII to Qualification of Equipment – Qualification of Mass Spectrometers	In progress	Revision
Evaluation and Reporting of Results – Appendix 3.4 “Verification of Out-Of-Specification Results in Animal Testing”	In progress	Revision
Annex 4 to “Evaluation of Measurement Uncertainty” – “Estimation of the Measurement uncertainty for the Biological Methods”	In progress	New draft

European Directorate for the Quality of Medicines & HealthCare

From standards to impact: building better health for all

Documents de management de la qualité élaborés en 2024

Quality Management Documents elaborated in 2024