FDA Issues Photosafety Guidance

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 01-26-2015 16:41


The US Food and Drug Administration has released final guidance, Photosafety Evaluation of Pharmaceuticals. 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. The guidance was developed within the Safety Implementation Working Group of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the ICH process. This document was endorsed by the ICH Steering Committee at Step 4 of the ICH process in November 2013. At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States.

The guidance includes factors for initiation of and triggers for additional photosafety assessment and should be read in conjunction with ICH M3(R2), section XIV(14) on Photosafety Testing.

The ICH M3(R2) guidance provides certain information regarding timing of the photosafety assessment relative to clinical development. It recommends that an initial assessment of phototoxicity potential be conducted and, if appropriate, an experimental evaluation be undertaken before exposure of large numbers of subjects (i.e. Phase III). Similarly, ICH S9 describes the timing of photosafety testing for oncology products. However, neither ICH M3(R2) nor ICH S9 provides specific information regarding testing strategies. This ICH S10 guidance outlines further details on when photosafety testing is warranted and on possible assessment strategies. This guidance generally applies to new active pharmaceutical ingredients, new excipients, clinical formulations for dermal application (including dermal patches), and photodynamic therapy products.

Source: FDA


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