S10 Photosafety Evaluation
S10 Photosafety Evaluation of Pharmaceuticals
The ICH Harmonised Guideline was finalised under Step 4 in November 2013. This Guideline provides international standards for photosafety assessment and harmonises 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.
Date of Step 4: 13 November 2013
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
WG Presentations / Trainings (Click the links below for complete guidelines)
*These Guidelines Belongs to ICH website.
