A short summary of the output from an ETERNAL Industry engagement workshop conducted as part of the Making Pharmaceuticals UK Conference programme held at the Coventry Building Society Arena, Coventry, United Kingdom, on 23rd and 24th April 2024 is now available.

Artificial Intelligence (AI) and Big Data (BD) presents an unprecedented opportunity within the framework outlined by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to enhance quality assurance, streamline drug development processes, increase traceability at supply chain level, and ultimately improve quality and safety of medicinal products. A new report generated by the ETERNAL Research and Innovation Action discusses the ethical considerations and legislative imperatives for integrating AI and BD within the ICH guidelines to ensure responsible usage and sustainable business outcomes.

We look forward into the year ahead with a sense of growing excitement as the ETERNAL project’s collaborative research and case study strands gather pace. With several parts of the project’s work programme starting to deliver early results and work progressing strongly across the board, we are looking forward to sharing some of the early highlights and our latest thinking at two notable gatherings of industrialists and researchers from the pharmaceutical and specialty chemicals sectors respectively in the first half of 2024.

A newly released public deliverable of the ETERNAL project lays out the key-drivers and a possible regulatory roadmap for “compliant-by-design” strategies applying the concepts of “greener design” to be delivered in Europe.

A key aspect of evaluating the environmental impact and sustainability of pharmaceuticals is assessing the risk that they may pose to ecosystems. A new public report from the ETERNAL project provides an overview of the current EMA regulation covering the environmental risk assessment of pharmaceuticals, followed by a comparison against the new proposed Regulation and Directive published earlier in 2023. The report concludes with a series of recommendations for integrating the latest scientific knowledge into pharmaceutical risk assessment to help fill gaps in the current and proposed legislation.

The prospect of new and transformed regulation for pharmaceuticals in the EU has got the ETERNAL team talking. This article explores the potential additional protection offered to the environment by the new proposals beyond what is currently in force.