Environmental Risk Assessments (ERAs) Therapeutic Drug Development
Recently we have had a number of enquiries and subsequent projects to utilise Peritus’ expertise for our Environmental Risk Assessment (ERA) services. Here, our Head of Toxicology Services, Dr Richard Reece-Jones briefly provides background information on ERAs.
ERAs are not new – the EMA has required ERAs for new marketing authorisations since 2006 and the FDA requires INDs/NDAs to have accompanying ERAs.
The purpose of ERAs for biopharmaceutical industry is examine the impact of their products on the broader ecosystem, over and beyond just toxicological evaluation – this is an important compliance risk regulation which all manufacturers need to include within their submissions to regulatory authorities.
It is well established that pharmaceuticals can have significant environmental impacts after they are excreted from humans and enter the environment directly through channels such as sewage treatment plants. The ERA involves investigating the fate and hazard profiles to determine the potential risks associated with these pharmaceuticals (APIs, metabolites, and other potentially harmful components) on the environment and organisms.
We have had a number of manufacturers who have been asked for their ERA for products by the regulators and approached us at Peritus Regulatory to support them.
The more holistic ERA compliance requires manufacturers to consider the wider ecosystem impact of their products. This may require the ERA to undertake further assessment and/or studies to identify, estimate/quantify the potential adverse effects of pharmaceuticals on both aquatic and terrestrial environments. The goal is to evaluate environmental hazards and outline necessary precautions. This may necessitate undertaking:
- Further toxicology studies & testing
- Product persistence within environmental settings
- Biodegradability impact and assessment studies
Peritus Regulatory Toxicologists have extensive experience of both the regulatory framework and design & management of aquatic ecotoxicology studies and programs. We work with our partner laboratories & CROs to undertake these studies in line with the regulatory requirements and build the appropriate dataset.
Please contact us for a free consultation with our ERA Advisers