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.

CHP PACKER INTERNATIONAL update 29
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