Non-clinical: environmental risk assessment
HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines
The European Medicines Agency's scientific guidelines on environmental risk assessment help medicine developers prepare marketing authorisation applications for human medicines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
- Environmental risk assessment of medicinal products for human use
- Environmental risk assessments for medicinal products containing, or consisting of, genetically modified organisms (GMOs) - Scientific guideline
- Scientific requirements for the environmental risk assessment of gene-therapy medicinal products