63rd AFI Symposium – Ivo Caldera’s interview

The ninth session of the AFI Symposium is dedicated to Environmental risk assessment (ERA) of medicinal products


The EMA guideline on Environmental Risk Assessment, issued in 2006, aims to limit the environmental impact resulting from the placing on the market and use of medicines for human use.

Drugs and their residues present in the environment, in fact, are considered “emerging” contaminants: looking at the drug as a potential pollutant is part of the integrated “One health” approach in which the health of humans, animals and the environment are strictly interdependent.

So, the prudent and responsible use of all medicines is an essential element for human and animal health and for the protection of the ecosystem.

The updated version

After 18 years, that guideline has now been updated by EMA and the new version will be applied starting from the next September. The new EMA guideline on Environmental Risk Assessment (ERA) introduces significant regulatory, methodological, and operational changes.

  • Regulatory updates include mandatory ERA for market authorization and periodic reassessments every five years.
  • Methodological innovations adopt the “One Substance, One Assessment” principle and include detailed evaluations for endocrine disruptors and antibiotic resistance.
  • Operationally, the EMA will now prepare risk-based monographs for individual ERA assessments and encourage data sharing among companies.

The IX session of the 63rd AFI Symposium, scheduled for June 6, is dedicated to these topics. The session, entitled “Environmental risk assessment (ERA) of medicinal products. The conventional approach and the prospects related to the new European Drug Directive, aims to offer a first overview of the scientific/regulatory approach adopted so far also in light of the significant changes indicated by the draft on the new European directive on medicines.

In addition to briefly illustrating the historical scientific approach suggested since the first EMA guideline (2006), the interventions will present the strategies adopted by the European authorities in addressing the issue of ERA.

Ivo Caldera, Coordinator of the AFI Environmental Safety and Hygiene study group, gave us a short interview in which he explains the concept of environmental risk of medicinal products.

During the interview, Caldera, who will moderate the session, introduces us to the guideline on the environmental risk assessment of drugs and its news approved.