ICH S10 Photosafety Evaluation Guidelines

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)

S10 Final Guidelines

Endorsed Documents (Click the links below for complete guidelines)

S10 Concept Paper

S10 Business Plan

WG Presentations / Trainings (Click the links below for complete guidelines)

S10 Training Material

*These Guidelines Belongs to ICH website.