Environmental risk assessment (ERA) for approving veterinary and human medical products

Why does the environmental risk assessment for drugs need to be updated?

News /

Drugs that are to be marketed in Europe must always be approved by the competent authority. For over 15 years, the environmental risk assessment (ERA) has been a mandatory part of the application for approval. The ERA systematically identifies risks of environmental damage. The aim of an ERA is to ensure that the drug manufacturer understands the possible environmental risks — such as impacts on drinking water and aquatic ecosystems, antibiotic resistance, adverse effects on microorganisms and other environmental interactions — and takes appropriate steps to minimize these risks.