Sunday, 3 March 2019

Guideline to assess risk of human medicines for the environment


EMA has published its guideline on the environmental risk assessment (ERA) of human medicines  for a six-month public consultation. Stakeholders are invited to send their comments by 30 June 2019.

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. For example, male fish exposed to the main ingredient in the contraceptive pill may become feminised and this can affect the capacity of the population to reproduce. Pharmaceuticals may also have indirect effects e.g. a recent study shows that pharmaceutical compounds detected in surface waters can transfer from invertebrate larvae to the predators that feed on them.

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. 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.

See: https://www.ema.europa.eu/en/news/revised-guideline-assess-risk-human-medicines-environment

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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