Delivering impact through partnership and innovation

At the European Directorate for the Quality of Medicines & HealthCare (EDQM), we are driven by a clear ambition: enabling better health for all by ensuring the quality, safety and accessibility of medicines and healthcare. We know we cannot achieve this alone – it requires close collaboration with our partners and stakeholders across Europe and beyond to turn shared standards into real impact for public health. And in a rapidly evolving global healthcare environment, this mission has never been more relevant – and our responsibility to deliver it, greater.

I would like to highlight three developments in 2025 that, in my view, significantly advanced the EDQM’s contribution in this context and demonstrate its lasting impact.

First, we reinforced the EDQM’s role as a global reference point for quality standards.

Through the continued development of the European Pharmacopoeia (Ph. Eur.) and our growing international engagement, the EDQM consolidated its position as a trusted partner across continents. Guided by continuous dialogue with our user community, we launched a new all-digital 12th Edition of the Ph. Eur., available exclusively via a completely redesigned online platform tailored to better meet users’ needs. At a time when global supply chains remain fragile, shared, accessible standards that reflect the latest scientific advances are neither a choice nor a technical detail: they are a cornerstone of health security.

Our approach to quality standards can also help us build a better, more humane society. With the introduction of alternatives for several long-standing animal-based safety tests, the European Pharmacopoeia Commission (EPC) signalled the end of general animal safety testing in the Ph. Eur. This transition reflects our commitment to combining scientific excellence with ethical responsibility and illustrates how the EDQM can help shape a future where scientific progress and societal values evolve together.

Second, we accelerated the transition towards more integrated and forward-looking approaches to public health challenges.

From tackling falsified medicines to supporting innovation in manufacturing and control, the EDQM continued to adapt its work to emerging risks and opportunities. This evolution reflects a deliberate shift: from reacting to challenges to anticipating them, and from working in silos to building coherent, system-wide responses. The EDQM not only strengthened regulatory efficiency by introducing reliance-based fast-track Certificate of Suitability assessments to support timely access to critical substances, it also helped mitigate the risks of medicine shortages through two complementary initiatives led respectively by the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) and the EPC, in co-ordination with other international initiatives. The first of these, the CD-P-PH’s Methodological guide to select medicines at risk of shortages, aims to develop a structured approach to identifying medicines that could become scarce during public health emergencies and – at the same time – the EPC’s newly launched European Drug Shortages Formulary provides a growing set of practical tools and standardised methods for unlicenced pharmaceutical preparations that can help alleviate the impact of medicine shortages.

Third, we strengthened global collaboration, outreach and impact by leveraging expertise, investing in our people and building trusted partnerships.

Behind every standard, every guideline and every programme are dedicated experts and committed partners. We deepened collaboration within our networks and across institutions, while fostering an internal culture that values openness, learning and continual improvement.

In 2025, the EDQM joined a major EU initiative aimed at strengthening regulatory systems for medicines across Sub-Saharan Africa in co-operation with the European Medicines Agency. Furthermore, Egypt’s accession to the General European Official Medicines Control Laboratories Network strengthened international collaboration in medicines quality control. Positioned as a trusted partner for global and regional regulatory convergence and reliance, the EDQM continued to build on the extensive expertise of its staff in co-ordinating such initiatives. This is essential: the credibility and effectiveness of our work ultimately depend on the trust we build – within our teams and with our stakeholders, within Europe and globally.

Taken together, these developments illustrate a clear direction: the EDQM is evolving as a more strategic, more connected and more impactful organisation. We are not only delivering outputs, we are shaping systems, strengthening partnerships and contributing to a shared vision of working together for better health, for all, grounded in quality and solidarity.

Looking ahead, the challenges remain considerable – from geopolitical uncertainty to technological disruption. I remain confident that the EDQM has the expertise, the commitment and the collective strength to meet them. By staying true to our values and by continuing to innovate, we will further enhance our contribution to public health in Europe and beyond.

Allow me to express my sincere appreciation to all those who contribute to this mission – our staff, our experts, our partners and our governing bodies. Their dedication and professionalism are, of course, the foundation of our achievements.

Together, we will continue to make quality matter – for patients, for health systems and for society as a whole. For better health, for all.

Petra Doerr, PhD
Director, EDQM, Council of Europe