EMA – Guideline on the Enviromental Risk Assessment of medicinal products for human use

In an increasingly environmentally conscious world, it is crucial to ensure that the drugs we consume do not pose a threat to our environment. This is where Environmental Risk Assessment (ERA) comes into play.

ERA is a fundamental process in the pharmaceutical industry involving a series of studies and scientific analyses aimed at identifying and quantifying the potential adverse effects that drugs may have on aquatic and terrestrial environments. These studies include toxicological tests, biodegradability studies, drug metabolism analysis, and assessment of their presence in different environmental compartments.

The new guideline from the European Medicines Agency (EMA), accepted on February 15 and set to come into effect on September 1, 2024, stipulates that an ERA report will be required for all new applications for marketing authorization of medicinal products for human use.