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My name is Gunter Waxenecker.
I'm working for the Austrian
Medicines and Medical
Devices Agency
and acted as a rapporteur
for the third revision
of the ICH S5 guideline
on the detection of
reproductive and
developmental toxicity
for human pharmaceuticals.
0:19
The views expressed in
this presentation are
my personal views and
may not be understood as
being made on behalf
of the position of
the European Medicines Agency
or one of its committees
or working parties,
nor does it reflect
the position of
the Austrian
Competent Authority.
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Detection of reproductive
and developmental toxicity
for human pharmaceuticals
is abbreviated as DART.
DART occupies a special
position in drug development.
First of all, because there's
a high background rate
for pregnancy losses
with 23 million miscarriages
occurring worldwide every year,
which is estimated to be
around 10-15% of all clinically
recognized pregnancies.
Secondly, because
prescription drug use
is common during pregnancy,
with 7 out of 10 reporting
to take at least one
prescription medicine.
The use of at least one
prescription medication
in the first trimester
increased by
35% between 1997 and 2018.
Thirdly, because
accidental drug exposure
during pregnancy still exists.
The unintended pregnancy
rate in Europe varies
11-94 per 1000 women
of reproductive age.
Finally, we have to deal with
biased epidemiological data.
The mean age of women
at childbirth is
meanwhile 30 or above,
since maternal age is a
significant risk factor
for spontaneous abortion,
and fetal loss is high in
women in their late 30s.
In parallel, there is
a strong age profile.
The higher the
age, the higher is
the likelihood of
taking medicines.
There are some unique
aspects of DART.
