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ICH Guideline S10 on photosafety evaluation of pharmaceuticals

We have adopted this International Scientific Guideline – ICH S10; CHMP/ICH/752211/2012 

Last updated

About this guideline

Overseas effective date: June 2014

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)

Note: See also finalised guideline 

Categories: ICH | Safety

Non-clinical | Toxicology | Other

TGA annotations: nil 

  • 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.
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For more information see International scientific guidelines adopted in Australia.

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