3. Regulatory and technical developments

3.1 Micropollutant analysis and monitoring capabilities

The regulatory context has changed in recent years. The Environmental Risk Assessment (ERA) of drugs for both human and veterinary use is a mandatory part of marketing authorization dossiers in Europe. The texts and reference documents used to carry out this assessment are currently being discussed and updated. Although environmental risk assessment procedures for marketing authorization dossiers are also implemented in North America, they are not applied or do not exist in all countries of the world.

As far as aquatic environments are concerned, drugs are currently included in the Water Framework Directive's watch list, and the inclusion of antibiotics is in line with the European Action Plan on Antimicrobial...