Environmental risk assessment: The ongoing update of CTD module 1.6 guideline in the European Union

<p>The environmental risk assessment for human medicinal products in the EU is going to be updated in order to adapt it to the technical progress. Significant changes are foreseen according to the guideline draft of EMA published end of 2018. In the commenting period until mid 2019 intense discussions took place questioning many of the intended changes and suggesting different ones. At the point in time of the compilation of this abstract the submitted comments have not been published yet, which could signify that not only a high number has been received, but also that considerable points have been raised. The time line of the guideline implementation process is unforeseeable. Therefore either the final guideline and its implications for the drug development process or the recent status will be presented. In any case the discontinuation of the option to use marketing data for refinement of the predicted environmental concentration can be expected. Consequently the use of epidemiological data originating from the EU becomes much more important to avoid undesirable leaflet warnings. Also implications to the preclinical toxicity and pharmacokinetic study designs seem likely. It can therefore be assumed that environmentally relevant properties should be considered earlier in drug development.</p>