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
English (EN) (401.2 KB - PDF)
Document history - First version (current)
ICH guideline S10 on photosafety evaluation of pharmaceuticals - Step 5
English (EN) (401.2 KB - PDF)
ICH guideline S10 - Guidance on photosafety evaluation of pharmaceuticals - Step 3
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.
English (EN) (184.69 KB - PDF)
Superseded documents
Concept paper on the need for revision of the note for guidance on photosafety testing
English (EN) (34.92 KB - PDF)
Note for guidance on photosafety testing
English (EN) (194.91 KB - PDF)
Questions and answers on the ‘Note for guidance of photosafety testing’
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.
English (EN) (121.93 KB - PDF)
Overview of comments received on 'Questions and answers on the ‘Note for guidance of photosafety testing’'
English (EN) (127.82 KB - PDF)
Question & answers on the note for guidance on photosafety testing
English (EN) (93.11 KB - PDF)
External links
- ICH S10 Step 2 Video Presentation (see S10 Step 2 Presentation under S10 Photosafety Evaluation: WG Presentations / Trainings)