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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.