ICH S10 Photosafety evaluation of pharmaceuticals

Current effective version

PDF iconAdopted guideline

Reference numberCHMP/ICH/752211/2012
Published31/01/2014
Effective from01/06/2014
KeywordsPhotosafety, phototoxicity, photoreactivity, photoallergy, non-clinical, clinical
DescriptionThis document provides guidance on photosafety testing strategies for pharmaceuticals. It applies to new active pharmaceutical ingredients, new excipients clinical formulations for dermal application and photodynamic therapy products.


Document history

First version

Current version

PDF iconAdopted guideline


PDF iconDraft guideline

In operation: 01/06/2014–present


Published: 17/12/2012

Superseded document


PDF iconConcept paper for the revision


PDF iconAdopted guideline


PDF iconQuestions and answers


PDF iconOverview of comments


PDF iconDraft questions and answers

Published: 24/01/2008


In operation: 01/12/2002–01/06/2014


Published: 17/12/2012


Published: 01/04/2011


Published: 19/07/2010


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