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0:00
Hello my name is David Jones.
I'm an independent consultant in
PharmacoToxicology and
my previous life was as
a non clinical assessor at
the UK's medicines and
healthcare products
regulatory agency
where I had been for 25 years.
While the UK was part of the EU,
I represented the
UK over the EMA
and I represented Europe
at the ICH level,
and I was the co-rapporteur
on this guideline
ICH S10 photo safety
evaluation of pharmaceuticals.
0:38
We all know about ICH.
We all know that it
came into being around
1990 and ICH these days
has gone beyond Japan,
Europe and USA and
actually covers most of
the whole world from a
pharmaceutical point of view,
and ICH meetings are
still held twice a year.
0:59
The ICH S10
photosafety evaluation
of pharmaceuticals
received approval by
the ICH Steering Committee in
2013 and was adopted
into use thereafter.
1:15
Now there is a section on
photosafety testing
in ICH M3 R2.
The guidance on nonclinical
safety studies for the conduct
of human clinical trials and
marketing authorization
to pharmaceuticals.
This discusses the timings of
the studies and does give some
guidance on requirements.
The ICH M3 R2 was
actually written before
ICH S10 had been thought about,
and the ICH M3 R2 guidance
is the subject of a
talk in this series.
