Tuesday, December 04, 2018

The European Medicines Agency (EMA) Has Revised Its Guideline On The Environmental Risk Assessment (ERA) of Pharmaceuticals.

 Pharmaceuticals and the environment.
Fig. 1 Pharmaceutical concentrations in caddisfly larvae. Mean pharmaceutical concentrations (ngg −1 dry weight ±1 SE) in caddisfly larvae
(Hydropsychidae) (n=6) at wastewater-influenced Brushy Creek. Each bar represents the mean concentration of a pharmaceutical compound in the six
individuals collected over two sampling dates. Colours represent therapeutic drug classes
The presence of pharmaceuticals in the environment has been a growing concern for a while and many agencies are working towards solutions. The impact of some of these substances seem to bring dire 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.
EMA has published a  PDF iconrevision of 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 to era_dg@ema.europa.eu using the Microsoft Office document icontemplate provided.

The presence of pharmaceuticals in the environment has been a growing concern for a while and many agencies are working towards solutions. The impact of some of these substances seem to bring dire 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.

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.

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