ICH S10 Photosafety evaluation of pharmaceuticals - Scientific guideline
This 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.
Keywords: Photosafety, phototoxicity, photoreactivity, photoallergy, non-clinical, clinical
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ICH guideline S10 on photosafety evaluation of pharmaceuticals - Step 5 (PDF/401.2 KB)
Adopted
First published: 31/01/2014
Last updated: 14/07/2014
EMA/CHMP/ICH/752211/2012 -
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ICH guideline S10 - Guidance on photosafety evaluation of pharmaceuticals - Step 3 (PDF/184.69 KB)
Draft: consultation closed
First published: 17/12/2012
Last updated: 17/12/2012
Consultation dates: 17/12/2012 to 01/03/2013
EMA/CHMP/ICH/752211/2012
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Concept paper on the need for revision of the note for guidance on photosafety testing (PDF/34.92 KB)
Draft: consultation closed
First published: 24/01/2008
Last updated: 24/01/2008
Consultation dates: 24/01/2008 to 31/05/2008
EMEA/CHMP/SWP/534549/2007 -
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Note for guidance on photosafety testing (PDF/194.91 KB)
Adopted
First published: 27/06/2002
Last updated: 27/06/2002
Legal effective date: 01/12/2002
CPMP/SWSP/398/01 -
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Questions and answers on the ‘Note for guidance of photosafety testing’ (PDF/121.93 KB)
First published: 11/04/2011
Last updated: 11/04/2011
EMA/CHMP/SWP/336670/2010 -
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Overview of comments received on 'Questions and answers on the ‘Note for guidance of photosafety testing’' (PDF/127.82 KB)
First published: 11/04/2011
Last updated: 11/04/2011
EMA/CHMP/SWP/170012/2011 -
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Question & answers on the note for guidance on photosafety testing (PDF/93.11 KB)
Draft: consultation closed
First published: 19/07/2010
Last updated: 19/07/2010
Consultation dates: 24/06/2010 to 30/09/2010
EMA/CHMP/SWP/336670/2010