New Photosafety guideline to be implemented by EU, US and Japan
The photosafety guideline, which is also known as S10, is aimed at harmonizing photosafety testing standards among these three regions, EU, US and Japan. The main purpose of having this initiative is that certain pharmaceutical products are capable of causing light-induced adverse reactions. These reactions can include tissue and immune system reactions under certain conditions.
The given guideline S10 was introduced by the International Conference on Harmonisation (ICH). This group basically deals with international regulatory harmonization and maintains harmony with regards to issues like these. The guidelines given by ICH are widely accepted and followed by health regulators. The three main regulators that are bound to these guidelines are European Medicines Agency (EMA) from EU, US Food and Drug Administration (USFDA) from the US and Pharmaceutical and Medical Device Agency (PMDA) from Japan.
The guideline S10 aims at establishing the testing requirements that the pharmaceutical companies need to assess and evaluate regarding the photsafety of their products. The ICH announces that the Phostosafety Evaluation guideline that has been long standing would now be implemented by the global regulators and in particular, EU, US and Japan.
The full guidance may be viewed Click Here