7 January 2014

The ICH S10 Guideline on Photosafety Evaluation reached Step 4 of the ICH Process in November 2013 and now enters the implementation period (Step 5).

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

The final Guideline is now available for download under the Safety Guideline page.