Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

A review of the advancements in photosafety testing with regard to ICH’s new topic S10: Photosafety evaluation of pharmaceuticals ***

Annette Kienapfel (geb. Lorenz) (Abschlußjahr: 2013)

Summary

Photosafety evaluation of pharmaceuticals is an integral part of non-clinical toxicity testing during drug development. However, first steps towards a defined regulatory environment for photosafety testing were made during the 1990s when EMA adopted a guideline on local tolerance testing [10] which provided brief information on photosafety evaluation until the release of EMA’s “Note for guidance on photosafety testing” [11] in 2002. Almost at the same time, FDA’s CDER published its “Guidance for industry on photosafety testing” in 2003 [13].
Since the release of the named guidances, pharmaceutical industry, regulatory authorities as well as academia generated data and increased their knowledge in the field of photosafety testing. This resulted in the revealing of certain shortcomings in the up-to-date approaches which comprise the lack of clarity in certain scientific questions related to photosafety evaluation (i. e. the conduct of a parallel testing approach versus a tiered approach, the lack of specifity of the 3T3 NRU-PT, the general lack of validated in vitro alternatives, the need for defined standards of in vivo tests as well as the question of whether tests for photogenotoxicity (and photocarcinogenicity) should be a pivotal part of any photosafety evaluation program). Furthermore, also the missing harmonization between ICH regions as regards testing strategies was identified as a subject to advancement of photosafety evaluation since global development programs of pharmaceutical companies require standard approaches in order to avoid duplicate work and to shorten development times.
A specific step towards a new, harmonized approach in the regulatory field of photosafety testing was ICH’s consensus in 2010 to start with its work on an independent guidance for photosafety testing, namely ICH S10: “Photosafety evaluation of pharmaceuticals”. Until finalization of this master thesis, the ICH process reached Step 2. The related draft guideline is comprehensively displayed and analyzed with regard to the above mentioned shortcomings for both, pharmaceutical industry and regulatory authorities.