FDA Adopts International Photosafety Testing Standard
Posted 27 January 2015 | By
New guidance published by the US Food and Drug Administration (FDA) would bring the US into alignment with an international standard meant to ensure new drug products don't cause photosensitivity in patients.
The standard, S10 – Photosafety Evaluation of Pharmaceuticals, was developed by the International Conference on Harmonisation (ICH), an international body composed of FDA, the European Medicines Agency (EMA), Japan's Pharmaceutical and Medical Device Agency (PMDA) and pharmaceutical industry groups.
ICH guidelines, after undergoing a lengthy consultation process, are meant to be enacted in all member states, thereby making it easier for companies to make submissions in multiple regions using the same data.
"The purpose of this guidance is to recommend international standards for photosafety assessment, and to harmonize such assessments that support human clinical trials and marketing authorizations for pharmaceuticals," FDA explains in its guidance document. "It should reduce the likelihood that substantial differences in recommendations for photosafety assessment will exist among regions."
As Regulatory Focus has previously reported, the S10 guideline was previously released in draft form by FDA in February 2013. The standard outlines the testing requirements for companies to show their products don't cause photosensitivity—literally a reaction to light—in patients. Some drugs can cause phototoxicity, photoirritation or photoallergies in patients, all of which generally cause burns (similar to—or in some cases much worse than—sunburns experienced after a day at the beach).
Unlike other ICH documents covering photosafety, including the M3(R2) and S9 documents, S10 provides "specific information regarding testing strategies" for photosafety. For example, FDA notes that only products which absorb photons at wavelengths between 290 and 700 nm should be considered for safety testing.
The document goes into effect immediately, FDA said.
S10 – Photosafety Evaluation of Pharmaceuticals (FR)