Message from the Director

As we embark on another year of progress and innovation, it is with great enthusiasm that we present the 2024 annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM). The year 2024 was particularly special as we celebrated several significant milestones, not least of which was the 60th anniversary of the European Pharmacopoeia (Ph. Eur.) and the EDQM itself, in addition to the 30th anniversary of two extraordinary initiatives: the European Network of Official Medicines Control Laboratories (OMCLs) and the Certification of suitability to the monographs of the European Pharmacopoeia (CEP) procedure. These anniversaries are not just markers of time but symbols of our unwavering dedication to excellence in public health protection.

We celebrated these anniversaries with exceptional events, including the international conference “Today, tomorrow, together for public health – Celebrating 60 years of excellence in public health protection” and our Open Day. They highlighted our achievements and fostered collaboration among stakeholders, reinforcing our mission to ensure access to safe and good-quality medicines and health products.

Throughout the year, we continued to address critical public health issues such as medicine shortages with initiatives like the European Drug Shortages Formulary (EDSForm) and the project to draft a methodological guide to select medicines at risk of shortage, as well as our active participation in other European and international initiatives addressing this issue.

Our efforts to protect animal welfare were marked by the removal of all general animal safety tests and the rabbit pyrogen test from the Ph. Eur. This reflects our commitment to ethical standards in keeping with the European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes of the Council of Europe.

The full implementation of the CEP 2.0 was another significant achievement. The new CEP format, designed with stakeholders’ needs in mind, was also supported by an ongoing campaign to improve the quality of applications through user training and better access to relevant information.

Our global outreach efforts were strengthened by our continued contribution to the expanded Pharmacopoeial Discussion Group (PDG), the reliance on the CEP procedure by the Brazilian Health Regulatory Agency (ANVISA), and the OMCL Network welcoming Türkiye as a full member.

Also in 2024, the new EU regulation on substances of human origin (SoHO) was adopted. The inclusion of the EDQM as an expert body and the referencing of EDQM technical guidelines in this regulation underscore our role in developing state-of-the-art technical guidelines in this field and is the result of a decade of fruitful and synergistic co-operation between the EU and the Council of Europe/EDQM in this area.

Looking ahead, we recognise the dynamic nature of public health, shaped by technological advancements, geopolitical changes and emerging health threats. Despite these challenges, we are confident in our ability to adapt and thrive, driven by a strong commitment to our vision, mission and strategic objectives. As defined in our Medium-Term Strategy (2024-2027), our focus remains on being responsive, enhancing global outreach and stakeholder engagement, ensuring sustainability, modernising our working methods, developing our people and fostering a culture of service.

I extend my heartfelt thanks to the dedicated staff of the EDQM. Your passion and expertise are the cornerstone of our success. I also express my gratitude to our partners, stakeholders and member states for their unwavering support and collaboration. Together, let’s continue to push the boundaries of excellence in public health, knowing that our collective efforts today will shape a healthier tomorrow – for all.

Petra Doerr, PhD
Director, EDQM, Council of Europe