EMER COOKE, EMA’S EXECUTIVE
DIRECTOR: 2025 ACHIEVEMENTS
IN MEDICINE REGULATION
2025 was a special year for EMA,
its staff and the whole European
Medicine Regulatory Network,
as it marked three decades since
the inception of the Agency, three
decades of progress in science and
medicines across the EU.

This year is also special because
it sets us up for a bright future
ahead. The agreement on the new
pharmaceutical legislation is a
historic milestone for medicines
regulation in Europe and for
patients across the EU, a golden
opportunity to become more agile
and efficient. Our direction is clear:
a fast path from innovation to safe
and effective medicines. Towards
this vision, in 2026, we will focus
our efforts in three areas:
First, we will take advantage of the
strengthened legislative framework
to reimagine how EMA works. We
have a unique opportunity to adapt
our regulatory system to deal with
rapid scientific and technological
advances, while increasing efficiency
through smart digitalisation and use
of artificial intelligence.

Second, we will intensify our
support for innovation for public
and animal health. We will further
enhance our early development
support to enable new medicines
to be authorised in the EU as
rapidly as possible.

Third, we will continue to invest
in our staff and build the network
of tomorrow. This investment in
the European medicines regulatory
network’s workforce will help build
capacity and capability so that we can
fully embrace the new challenges
and opportunities that lie ahead.

At the end of the year, we can look
with pride at its achievements. In
2025, we recommended 104 new
medicines for human use. Almost
40% of them contain a completely
new active substance. In the
veterinary area, we recommended a
record-breaking 30 new medicines,
among them several new vaccines.

There were many remarkable new
treatments, both in human and
veterinary medicine, and let me
highlight just a few:
- the first treatment to delay the
onset of stage 3 type 1 diabetes in
adults and children from 8 years
- the first treatment against
Duchenne muscular dystrophy in
patients from the age of six who
can walk
- the first vaccine in the EU to
protect adolescents from the age
of 12 against Chikungunya
- two new bluetongue vaccines to
protect sheep and cattle
Beyond the evaluation of new
medicines, we recommended
changes to the way the antibiotic
azithromycin is used in the EU
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to minimise the development
of antimicrobial resistance. We
also recommended measures
to minimise the risk of suicidal
thoughts with finasteride and
dutasteride medicines, used by men
to treat androgenetic alopecia.

EMA, the Commission and the
Heads of Medicines Agencies set
new ambitious targets to increase
the number of multinational clinical
trials taking place in the EU. We also
launched a new clinical trials map in
all EU languages to provide patients
and healthcare professionals with
easy access to comprehensive, real-
time information about clinical trials
conducted in their area.

The strength of a coordinated
system is key to addressing the
shortages problem at EU level. The
launch of the European Shortages
Monitoring Platform in January
2025 provides a strong technical
backbone for our work with EU
national authorities and actors
across the supply chain to prevent
and manage shortages.

We embraced new partnerships
and strengthened the ones we
have, to rebuild trust in science.

Timely, clear and accurate health
information - delivered with
empathy and targeted to the needs
of diverse audiences - is crucial to
our public health mission.




NEW DATA ON ANTIMICROBIALS SALES AND USE IN
ANIMALS IN THE EU
The second European Sales and
Use of Antimicrobials for Veterinary
Medicine (ESUAvet) annual
surveillance report is now published,
consolidating data from the EU
including Iceland and Norway in
2024. Together with the report a
new dashboard is launched allowing
public access to data on the sales of
antimicrobial veterinary medicinal
products (VMPs) across the EU.

“With ESUAvet, we are not just
collecting data - we are building
trust, enabling action, and contributing
to a healthier future for all. Reliable
data support smarter decisions
and safer communities. By turning
data into insight, we empower
countries to take informed action
against antimicrobial resistance,”
said Ivo Claassen, Head of Veterinary
Medicines Division at EMA.

In 2024, 98% of total sales of
antimicrobial VMPs were for food-
producing animals. Sales for this
group increased by 5% compared
to 2023. These results suggest
that the overall declining trend
observed between 2010 and 2022
may be slowing down or reversing.

More data will be needed in the
future to determine whether
this reflects a lasting shift or a
temporary fluctuation, which
can be caused by factors such
as stockpiling, disease outbreaks
or changes in animal population.

Continued close monitoring and
timely reporting will be essential
to support corrective actions, if
needed. and turkeys, marking a strategic
shift towards more granular and
actionable insights.

Variability between countries still
limits EU-level aggregation, but
countries are working hard to
improve the completeness and
granularity of their use data. It
is important that these efforts
continue, as these data offer new
opportunities to understand
consumption patterns and guide
targeted interventions.

Alongside this report, ESUAvet
is launching a new interactive
dashboard. This tool offers broad
public access to antimicrobial
VMP sales data, empowering
stakeholders - from policymakers
to the general public - to
explore and understand trends
in veterinary antimicrobial
consumption patterns to support
decision making.

While sales data remain a reliable
proxy for estimating antimicrobial
consumption in food-producing
animals, actual consumption is
monitored through use data
reporting, now in its second
year for cattle, pigs, chickens,
EMA AND FDA SET COMMON PRINCIPLES FOR AI IN
MEDICINE DEVELOPMENT
EMA and the U.S. FDA have jointly
identified ten principles for good
artificial intelligence (AI) practice
in the medicines lifecycle. The
principles give broad guidance on
AI use in evidence generation and
monitoring across all phases of a
medicine, from early research and
clinical trials to manufacturing and
safety monitoring.

The principles are relevant for
those developing medicines, as
well as for marketing authorisation
applicants and holders. They will
underpin future AI guidance in
the different jurisdictions and
support enhanced international
collaboration among regulators,
organisations setting technical
standards and other stakeholders.

Guideline development in the EU
is already underway, building on the
EMA AI reflection paper published
in 2024.

The use of AI technologies
across the medicines lifecycle has
increased significantly in recent
years. AI holds great promise as a
tool to accelerate the path from
innovation to safe and effective
medicines. The new pharmaceutical
legislation accommodates the
broader use of AI in the lifecycle of
medicines in regulatory decision-
making and creates additional
possibilities for testing innovative
AI driven methods for medicines in
a controlled environment.

To realise these benefits, AI
needs to be expertly managed.

As AI continues to evolve, a
principles-based approach will
help regulators, pharmaceutical
companies and medicines
developers harness the potential of
these technologies while ensuring
patient and animal safety and
regulatory compliance.

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