HIGHLIGHTS OF DECEMBER 2025
MEETING The Management Board opened
its meeting welcoming the
political agreement reached by
the European Commission, the
European Parliament and the
Council of the European Union
on the new EU pharmaceutical
legislation. The legislation
represents a historic milestone
for European medicines regulation
and for patients across the EU,
creating significant opportunities to
strengthen Europe’s position as a
leader in pharmaceutical innovation.

The Board adopted EMA’s work
programme for 2026, which
sets out the Agency’s priorities
for the coming year. While
EMA will continue to ensure
the highest standards in the
evaluation and supervision of
human and veterinary medicines,
work during 2026 will focus
on intense preparation for the
changes introduced by the new
EU pharmaceutical legislation,
supporting innovation for public
and animal health and investing
in developing our staff across the
European medicines regulatory
network. As EMA carries out its
work across these three areas,
it will seize opportunities to
modernise the regulatory system
in response to rapid scientific and
technological advances, enhancing
efficiency through digitalisation
and artificial intelligence, while
expanding early development
support to enable new medicines
to be authorised in the EU as
rapidly as possible.

The Board adopted the final
programming document for 2026-
2028 (to be published at the end of
January 2026) and the preliminary
programming document for 2027-
2029. The Agency’s budget for 2026
was also adopted, increasing by
2.6% compared to 2025 to over
615 million euros, driven primarily
by increased fee income from
the growing product portfolio of
centrally authorised products.

The Board adopted a governance
structure to guide and oversee
EMA’s implementation of the
pharmaceutical legislation and its
impact on the network. A new
group, including representatives
from EMA, the Management Board
and the European Commission, will
oversee work across workstreams
on the centralised procedure and
committees, development support,
environmental risks, quality and
manufacturing, shortages and other
regulatory and legal aspects.

Both the centralised procedure/
committee and development
support workstreams will also
include civil society representatives
(patients and healthcare
professionals). This integrated
approach aims to ensure close
coordination between EMA, the
Committee for Medicinal Products
for Human Use (CHMP), the
Pharmacovigilance Risk Assessment
Committee (PRAC) and the
Coordination Group for Mutual
Recognition and Decentralised
Procedures (Human) (CMDh),
the Commission, the European
medicines regulatory network
and stakeholders, throughout
the implementation of the new
legislation. The Commission updated the
Board on the proposals for a
revision of the Medical Device
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Regulation ((EU) 2017/745) and
the In Vitro Diagnostic Medical
Device Regulation ((EU) 2017/746),
which assign new responsibilities
to EMA regarding the management
of medical device expert panels,
to work with the Commission
to set up and manage an IT
system for reporting and sharing
information on supply interruptions
or discontinuation of critical
medical devices. This would also
provide support to the national
competent authorities for medical
devices to facilitate the exchange
of experience, cooperation and
coordination in certain areas.

The Board also welcomed the
publication of the Commission’s
proposed Biotech Act, which is
designed to further boost biotech
innovation and research in the EU
and includes several amendments
to the EU Clinical Trials Regulation.

Dr Sabine Scherer, chair of EMA’s
Paediatric Committee (PDCO),
updated the Board on key activities
of the PDCO in 2025, emphasising
efforts to facilitate the development
of paediatric medicines. She noted
that the 2007 EU Paediatric
Regulation has significantly
augmented the development of
medicines for children, resulting in
an increased range of treatment
options. Nevertheless, children
remain underrepresented in clinical
development, which is still leading
to delayed access to innovative
treatments and reliance on off-label
prescribing. Dr Scherer also underlined the
importance of further strengthening
patient and healthcare professional
engagement in paediatric drug



development to improve
program feasibility and
implementation success rates.

Looking ahead, Dr Scherer noted
that the new pharmaceutical
legislation may create an even
more favourable environment for
paediatric medicine development,
positioning the EU to drive
innovation that will benefit
children across the region.

In the first half of 2026, EMA
will launch a competitive tender
to extend the work of the
Data Analysis and Real World
Interrogation Network (DARWIN
EU) from 2027 to 2032.

DARWIN EU provides the
infrastructure, data and tools
needed to generate relevant and
reliable real-world evidence on
diseases, populations and medicine
performance across Europe
through a federated approach.

Since its inception in 2022, more
than 100 studies have been
initiated and 32 data partners have
joined, enabling the use of health
data from 188 million patients
across 16 European countries to
answer research questions around
the use of medicines.

USE OF PARACETAMOL DURING
PREGNANCY UNCHANGED IN THE EU
A recent systematic review and
meta-analysis published in The
Lancet Obstetrics, Gynaecology,
& Women’s Health has found no
evidence that using paracetamol at
recommended doses during
pregnancy increases the risk of
autism spectrum disorder, ADHD or
intellectual disability in children. This
supports the existing evidence and
advice that the EMA issued on the
use of paracetamol during pregnancy
In the EU, paracetamol (also known
as acetaminophen) can be used
for reducing pain or fever during
pregnancy if clinically needed. There
is currently no new evidence that
would require changes to the
current EU recommendations for
use. As included in the product
information for paracetamol in
the EU, a large amount of data
from pregnant women who used
paracetamol during pregnancy
indicates no risk of malformations in
the developing foetus or newborns.

In 2019, EMA reviewed available
studies that investigated the
neurodevelopment of children
exposed to paracetamol in utero
and found that the results were
inconclusive, and that no link with
neurodevelopmental disorders could
be established.

When needed, paracetamol can
be used during pregnancy. As with
any medicine for acute treatment,
it should be used at the lowest
effective dose, for the shortest
possible time and as little as possible.

Pregnant women should speak to
their healthcare professional if they
have questions about any medication
during pregnancy.

As for all medicines, EMA and the
national competent authorities in
the EU will continue to monitor
the safety of medicines containing
paracetamol and promptly evaluate
any new data as they emerge.

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