EMA / CHMP / SWP / 4447 / 00 Rev. 1-Corr.
Navigate the EMA ERA decision tree
Navigate the EMA ERA decision tree
one question at a time.
Answer the relevant regulatory questions in sequence. The navigator applies the Phase I and PBT/vPvB logic separately, while carrying shared findings forward so you do not answer the same scientific question twice.
Source controlledEMA Revision 1 (effective 1 Sep 2024)
Expert follow-upUse the decision record to discuss the assessment pathway with ToxWriter
PrintableReview the decision and print/save as PDF
WHAT THIS TOOL DOES
Shared screeningCommon findings such as natural status and non-natural peptide/protein classification are used across both pathways.
Automatic stop pointsWhen the guideline provides a stopping condition, the tool tells you exactly what stops and what remains independent.
Clear conclusionsPhase I, Phase II and PBT/vPvB outcomes are reported separately and with guideline references.
Assessment recordGenerate a final report containing inputs, answers, calculations, decision path and notes.