ICH S10 Photosafety evaluation of pharmaceuticals

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Current effective version

Adopted 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

Adopted guideline


Draft guideline

In operation: 01/06/2014–present


Published: 17/12/2012

Superseded document


 

Concept paper for the revision


Adopted guideline


Questions and answers


Overview of comments


Draft 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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