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Revised guideline to assess risk of human medicines for the environment

Environmental risk assessment of medicines ensures that the potential effects of pharmaceuticals on the environment are studied and that adequate precautions are taken in case specific risks are identified. Performing an ERA is mandatory for any pharmaceutical company submitting a marketing authorisation application for a medicine, regardless of the type of medicine. Appropriate details are included in the European Public Assessment Report (EPAR) of approved medicines, so that this information is available to the public.

The revision of EMA’s guideline on ERA introduces a decision tree clarifying when ERA studies are required and provides more detailed technical guidance to applicants to increase the consistency of the assessments.

One of the most notable changes introduced in the proposed revision is the introduction of the term ‘endocrine active substances’, to include all compounds that affect development or reproduction. Additionally, guidance is provided for the estimation of the exposure of predators to pharmaceuticals through the food chain (‘secondary poisoning’), as well as directly through the environment. The revision also proposes to limit the use of a laboratory test method - the Organisation for Economic Co-operation and Development (OECD) 308 environmental fate test - to certain categories of substances and this will reduce the burden of testing on applicants.

In the interest of animal welfare, the guideline encourages applicants to share data generated for the ERA, implementing the principles of 3Rs (Replacement, Reduction and Refinement) - in accordance with Directive 2010/63/EU - to avoid unnecessary repetition of studies.

Please refer to the full EMA publication here