The European Medicines Agency (EMA) has published a iconrevision of its guideline on the environmental risk assessment (ERA) of human medicines for a six-month public consultation.
The presence of biologically-active pharmaceuticals in the environment is a growing concern, because some of these substances have shown direct effects on wildlife at or below the concentrations found in water and soil.
Human medicines may enter the environment during their manufacture, use and disposal. The ERA is based on the use of the product and the physico-chemical, ecotoxicological and fate properties (degradation, persistence) of its active substance. 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.
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 to certain categories of substances and this will reduce the burden of testing on applicants.
The revision of the ERA guideline is based on a concept paper issued in 2014 and the work of a group of EMA’s human medicines committee (CHMP). It builds on the twelve years of experience gained since the original guideline was published and aims to facilitate the work for both applicants and regulators in the interest of environmental protection.