“Environmental risk assessment of medicinal products for human use” according to revised EMA guideline (EMEA/CHMP/SWP/4447/00 Rev. 1)

The marketing authorisation of medicinal products for human use (HMP) requires an environmental risk assessment (ERA, CTD Module 1.6.1). It is based on the maximum daily dose (MDD) and depends on the physico-chemical, ecotoxicological, and fate properties of the active substance(s).

Numerous changes and new features arise from the revision, e. g., with regard to the test strategies to be used (e. g., antibiotic agents), the assessment of possible secondary poisoning and the methodology. The guideline is significantly more comprehensive and the requirements are more stringent. It provides a detailed overview of the assessment and a decision tree for Phase I.

Modul 1:

• Legal basis of the Environmental Risk Assessment (ERA) of medicinal products for human use
• ERA guideline EMEA/CHMP/SWP/4447/00 Rev. 1 – Principles and Overview –
• Changes to former guideline
• ERA guideline EMEA/CHMP/SWP/4447/00 Rev. 1 – Phase I and PBT assessment –
• Database search and requirements on data quality

Modul 2:

• Compartment specific Phase II assessment, Part 1: Physico-chemical properties, fate, ecotoxicity, trigger values
• Part 2: Compartment specific Phase II assessment and changes to former guideline
• ERA Module 1.6.1 template
• Overview over study costs and timeline

The modules can be booked individually.