On 21 March 2024, the European Medicines Agency (EMA) published a new guideline for the environmental risk assessment (ERA) of medicines for human use. This guideline, which will come into force on 1st September 2024, aims to protect ecosystems by providing detailed protocols for analysing the environmental impact of drugs, including chemical-physical characterisation, environmental fate and ecotoxicology studies according to Good Laboratory Practice (GLP).

The guide emphasises the importance of environmental risks assessment and suggests precautionary and mitigation measures. It also offers guidance on how to document the results in a risk assessment report.

Our team is available to assist in complying with the new standards and applying the required assessment methodologies.

For more information, please feel free to consult TEAM mastery!

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