The purpose of this guidance is to recommend international standards for photosafety assessment, and to harmonize such assessments that support human clinical trials and marketing authorizations for pharmaceuticals. This guidance includes factors for initiation of and triggers for additional photosafety assessment and should be read in conjunction with ICH M3(R2), section XIV(14) on Photosafety Testing (Ref. 1). It should reduce the likelihood that substantial differences in recommendations for photosafety assessment will exist among regions.


This guidance is divided into several sections:


  • Section II(2) discusses factors to consider in any evaluation of photosafety.

  • Section III(3) describes existing nonclinical photosafety tests, but this section does not describe specific testing strategies.

  • Section IV(4) mentions clinical photosafety assessment. 

  • Section V(5) provides strategies for determining how to assess photosafety for drugs given by routes intended to produce systemic exposure or by the dermal route using the considerations and tests described in sections II(2), III(3), and IV(4).


Consideration should be given to the use of non-animal methods or clinical data for photosafety assessment, which could reduce the use of animals in accordance with the 3R (replacement/reduction/refinement) principles.



Posted on the FDA website on 27 January 2015