EMA ERA Decision Tree & Navigator
Interactive decision-support tool for navigating Phase I and PBT/vPvB ERA pathways.
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Regulatory Toxicology & Pharmaceutical ERA Resources
Practical background on environmental, health-based exposure-limit and occupational toxicology topics. These pages are general information and should be applied to project-specific regulatory requirements with appropriate scientific review.
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Regulatory background and practical guidance.
These resources provide general regulatory background and are not downloadable assessment reports. Project-specific calculations, study evaluation and confidential conclusions are handled through the assessment request process.
Pharmaceutical ERA: Phase I and Phase II
Understand the stepwise environmental risk assessment pathway for human medicinal products.
EU and UK Pharmaceutical ERA
Review the relationship between the EMA framework and current UK ERA expectations.
PECSW and FPEN in ERA
Understand the Phase I exposure calculation and population-fraction refinement concepts.
PBT / vPvB in pharmaceutical ERA
Background on persistence, bioaccumulation and toxicity considerations within ERA.
PDE / ADE methodology
Learn how PDE / ADE assessments use pharmacological and toxicological evidence.
OEL / OEB / OHC
Understand workplace exposure limits and exposure-band concepts.
HBEL, PDE & OEL guidelines and databases
Direct links to selected EMA, ICH and OSHA public references.
ERA vs PDE vs OEL
Compare the questions answered by environmental, health-based and occupational exposure assessments.
ERA for generic medicines
Understand how submission context and anticipated environmental exposure influence ERA requirements.
Pharmaceutical ERA data requirements
Review the environmental exposure, fate, effects and risk-characterisation evidence typically considered.
PEC and PNEC in pharmaceutical ERA
Understand the two core concepts used in environmental risk characterisation.
ERA data access and LOA
Understand the distinction between public ERA information and rights to rely on underlying data.
Project support
Need a project-specific assessment?
Share the substance, product context, intended market and regulatory requirement. ToxWriter can review the scope and confirm the appropriate assessment pathway.