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0:00
Hello. This is Jan
Willem van der Laan.
I'm retired from
the Medicines Evaluation
Board in the Netherlands,
and I will give a
talk today about
the non-clinical part of the
common technical dossier.
I will explain more
about this document.
0:24
The title of the
multidisciplinary topic 4
is an early one in the ICH
process, in the early 90s,
we started with a common
technical document to have
a harmonized dossier over
Europe, America, and Japan.
That's important to
reduce the efforts of
the pharmaceutical industry in
the requirements
for a new dossier.
It's a non-clinical
approach today.
However, the toxicology is
hardly the topic of this part,
it's more organizational.
Common technical document
for the registration of
pharmaceuticals for
human use is done on
safety on the
non-clinical overview
and the non-clinical
summaries in Module 2
and the organization
of Module 4,
and I will explain
more in a moment.
1:20
In fact, the structure
of the dossier is
an overall structure of
the whole dossier in
a type of triangle.
You see it on the screen.
At the lowest level of the
triangle is describing
the various parts
of the dossier:
The quality part, the
non-clinical study reports,
and the clinical study reports.
The middle level is Module 2.
It's the summary
and the overview,
and I will explain
the difference
between overview and
summary later on.
In fact, the top
of the triangle is
not part of the common
technical dossier
in the sense that it is not
the unharmonized description,
and I will also start with that.
