EMA: Revision of Guideline on Environmental Risk Assessment (ERA) enters into force
This guideline is an essential reading for all regulatory professionals involved in preparing MAAs. It describes the revised requirements for assessing the potential environmental risks of human medicinal products. The guideline was adopted on 15 February 2024 and will enter into force on 1 September 2024. The changes and extended requirements for environmental risk assessment will be mandatory for all pharmaceutical companies placing their medicines on the EU market.
An ERA must comprise detailed protocols for analysing the environmental impact of drugs, including chemical-physical characterisation, environmental fate, and ecotoxicology studies of its active substance(s). The identification of potential hazards of the active substance of a medicinal product is described along with detailed guidance on how to document the results in a risk assessment report and also suggests precautionary and mitigation measures.
Revision 1 of the guideline was published on 22 August 2024 including new wording in Section 3.1. It was amended to clarify requirements for excipients. Furthermore, editorial corrections were made throughout the text.
Source:
EMA: Guideline on the environmental risk assessment of medicinal products for human use
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