International scientific guideline: ICH Guideline S10 on photosafety evaluation of pharmaceuticals

About this guideline

Overseas effective date: June 2014

Categories: Nonclinical | Toxicology | Other toxicity

Replaces: CPMP/SWP/398/01 Note for Guidance on Photosafety Testing (Adopted by TGA 17 September 2004) and EMA/CHMP/SWP/336670/2010 Question and answers on the 'Note for guidance on photosafety testing' (provided for information 24 February 2014)

Access this international scientific guideline

TGA annotations

See also: Finalised guideline (pdf,265kb)

For more information see International scientific guidelines adopted in Australia.

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.