ToxWriter provides project-focused Environmental Risk Assessment support for human medicinal products. The assessment pathway is adapted to the active substance, product, intended market and available environmental evidence, with scope aligned to the applicable regulatory framework.
The current EMA guideline describes assessment of the potential environmental risks of human medicinal products, considering environmental exposure, environmental fate and effects, and relevant hazard characteristics of the active substance.
Phase I follows a decision tree and concludes with a predicted environmental concentration in surface water (PECSW). The current EMA action limit is 0.01 µg/L for entry to Phase II, subject to specific strategies for certain substance groups.
Where required, Phase II evaluates environmental fate and effects across relevant compartments and supports risk characterisation using predicted environmental concentrations and predicted no-effect concentrations.
The ERA also considers relevant environmental hazard properties, including persistence, bioaccumulation and toxicity (PBT/vPvB) where applicable. Certain substance groups may require tailored assessment or testing strategies.
The current EMA guideline states that the total residue approach assumes the active substance is completely excreted as parent compound, unless metabolites are assumed to have similar or lower toxicity. Metabolism may be considered in Phase II where applicable.
This is a regulatory assessment convention; project-specific justification is still needed where the substance or metabolite profile creates a different scientific question.
EMA notes that public assessment reports and summary data from other regulatory frameworks cannot be used as ERA dossier data by another applicant without the necessary access rights. Where relevant, underlying study reports should be available and submitted.
This is particularly important when an existing innovator ERA is being considered as a starting point for a new submission.
An Environmental Risk Assessment evaluates the potential environmental exposure, fate, effects and risk associated with the use of a human medicinal product and its active substance.
ToxWriter can adapt the assessment to the applicable EU or UK submission context, including environmental exposure and prevalence considerations relevant to the market.
The assessment can progress to environmental fate and effects work and risk characterisation, with the exact data needs depending on the substance and applicable assessment strategy.
Yes. The profile directory is not intended to limit the service scope. Custom Environmental Risk Assessment requirements can be reviewed directly with ToxWriter.
The website directory shows profiles only. Detailed calculations, study data and confidential conclusions are not published here.
Interactive decision-support tool for navigating Phase I and PBT/vPvB ERA pathways.