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ICH 10 photosafety evaluation of pharmaceuticals

Published on April 30, 2026   21 min

A selection of talks on Pharmaceutical Sciences

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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.

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ICH 10 photosafety evaluation of pharmaceuticals

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