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

Current effective version

ICH guideline S10 on photosafety evaluation of pharmaceuticals - Step 5

Adopted Reference Number: EMA/CHMP/ICH/752211/2012

Document history - First version (current)

ICH guideline S10 on photosafety evaluation of pharmaceuticals - Step 5

Adopted Reference Number: EMA/CHMP/ICH/752211/2012

ICH guideline S10 - Guidance on photosafety evaluation of pharmaceuticals - Step 3

Draft: consultation closed Consultation dates: 17/12/2012 to 01/03/2013 Reference Number: EMA/CHMP/ICH/752211/2012 Summary:

The purpose of this document is to recommend international standards for photosafety assessment, and to harmonise such assessments supporting human clinical trials and marketing authorization for pharmaceuticals. It includes criteria for initiation of and triggers for additional photosafety testing and should be read in conjunction with ICH M3(R2), Section 14 on Photosafety Testing (Ref. 1). This guideline for photosafety assessment should reduce the likelihood that substantial differences in testing requirements and data interpretation will exist among regions.

Superseded documents

Concept paper on the need for revision of the note for guidance on photosafety testing

Draft: consultation closed Consultation dates: 24/01/2008 to 31/05/2008 Reference Number: EMEA/CHMP/SWP/534549/2007

Note for guidance on photosafety testing

Adopted Reference Number: CPMP/SWSP/398/01 Legal effective date: 01/12/2002

Questions and answers on the ‘Note for guidance of photosafety testing’

Reference Number: EMA/CHMP/SWP/336670/2010 Summary:

The aim of this Questions & Answers document is to provide clarification to the Note for Guidance on Photosafety Testing (CPMP/SWP/398/01) on revised regulatory positions regarding specific aspects of photosafety testing.

Overview of comments received on 'Questions and answers on the ‘Note for guidance of photosafety testing’'

Reference Number: EMA/CHMP/SWP/170012/2011

Question & answers on the note for guidance on photosafety testing

Draft: consultation closed Consultation dates: 24/06/2010 to 30/09/2010 Reference Number: EMA/CHMP/SWP/336670/2010