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
22 CHP PACKER INTERNATIONAL update
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.