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.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
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