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Regulatory Focus™ > News Articles > 11 > How Pharmaceuticals Impact the Environment: EMA Revises Guideline

How Pharmaceuticals Impact the Environment: EMA Revises Guideline

Posted 30 November 2018 | By Zachary Brennan 

How Pharmaceuticals Impact the Environment: EMA Revises Guideline

The revision of the European Medicines Agency’s (EMA) guideline on environmental risk assessment (ERA) introduces a decision tree clarifying when ERA studies are required and provides more detailed technical guidance to help 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,” EMA explained. “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.”

Building on 12 years of experience since the original guideline was published, the revision of the ERA guideline is based on a 2014 concept paper and the work of a group of experts led by the Safety Working Party of EMA’s CHMP.


Performing an ERA is mandatory for any pharmaceutical company submitting a marketing authorization application for a medicine. The assessments are meant to assess the potential effects of pharmaceuticals on the environment and ensure that adequate precautions are taken if specific risks are identified. 

The ERA is based on the use of the product and the physico-chemical, ecotoxicological, and degradation and persistence of its active substance.

“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,” EMA said. “For example, male fish exposed to the main ingredient in the contraceptive pill may become feminized 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.”

Comments on the revised guideline are due 30 June 2019.



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