ICH S10 Photosafety evaluation of pharmaceuticals

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Current effective version

Adopted 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

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Superseded document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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