As part of the broader legislative reforms under the EU's pharmaceutical regulatory framework – changes relating to environmental risk assessments (ERAs) outlined in the new version of the EMA guidelines (EMEA/CHMP/SWP/4447/00 Rev. 1- Corr.) are having significant ramifications, particularly for generic pharmaceuticals. Previously, following the introduction of the first ERA guidelines in 2006 the requirement to assess the potential impact of a drug on the environment was the responsibility of the originator company. For generic drugs the requirement for an ERA could be waived with the justification of no increased environmental exposure. However, the latest updates to the guideline, which came into force in September 2024, removed this option for generic drugs. Requiring, instead, access to previous ERAs submitted by marketing authorisation holders, or performance of a new ERA in accordance with the revised guidelines.

The revised guidelines require a comprehensive analysis of the environmental impact of drug substances, which encompasses chemical-physical characterisation, environmental fate, and ecotoxicology studies of active substances. Furthermore, the revised guidelines require consideration of specific hazards that may have been ignored under the previous version. For example; endocrine disrupting substances and antibacterials require a specific “tailored testing strategy”. This initiative aims to minimise the environmental footprint of medicinal products by implementing stricter assessment criteria and mitigation measures.

With far greater emphasis on improving safety and sustainability of pharmaceuticals in the European Union, these changes are intended to deeply embed environmental considerations into the regulatory framework for pharmaceuticals.
 

Key Changes to the Pharmaceutical ERA Guidelines

• Enhanced requirements for the environmental risk assessments of pharmaceuticals, particularly generic drugs.
• Modifications to testing requirements and triggers, e.g. removal of the OECD 308 as a mandatory study.
• Enhanced utilisation of publicly available data (scientific literature) to ensure an up-to-date assessment.
• Enhanced consideration of specific hazards, e.g. endocrine disruption, antimicrobial.
   

The expected outcome is to harmonise the internal market, ensuring timely access to safe, effective, and affordable medicines that are also environmentally sustainable. These regulatory changes emphasise the importance for pharmaceutical companies, especially those involved in the production and distribution of generic drugs, to stay abreast of these developments and integrate robust environmental risk assessment processes into their product lifecycle.
 

Blue Frog Scientific specialises in environmental risk assessment of pharmaceuticals and has extensive experience in consortium management and advocacy. If you’re currently revising your strategy or wondering about the potential impacts of these legislative changes, our pharmaceutical ERA experts would be very interested in talking with you.