Photosafety testing

Photosafety testing (testing for adverse effects of drug products in the presence of light) is recommended only when it is felt that the results of such testing would yield important safety information or would be informative for the consumer and healthcare practitioner. 

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The European Agency for the Evaluation of Medical Products, Committee for Proprietary Medicinal Products, Note for Guidance on Photosafety Testing, London, 2002... 

FDA Guidance for Industry Photosafety Testing, 2003. Guidance documents, published by the FDA, represent the agency s current thinking on a particular subject. They can be accessed at www.fda.gov/cder/guidance/index.htm. 

CPMP (December 2002) Note for the guidance on photosafety testing, CPMP/SWP/398/01, http //www.emea.eu.int/pdfs/human/swp/039801en.pdf. 

FDA, CDER (May 2003) Guidance for industry photosafety testing, http //www.fda.gov/cder/ guidance/3 640fnl.pdf. 

EMEA guideline CPMP/SWP/398/01 CPMP Note for guidance on photosafety testing, adopted June 2002. 

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