ICH S10 Photosafety evaluation of pharmaceuticals

Current effective version

PDF iconAdopted guideline

Reference numberCHMP/ICH/752211/2012
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Superseded document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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