Drug safety assessment within a sustainable development framework

Abstract

The pharmaceutical sciences are inherently part of Goal no. 3 of the 17 United Nation's Sustainable Development Goals (SDGs) of the 2030 Agenda for Sustainable Development: "ensure healthy lives and promote well-being for all at all ages". This concept includes challenges in the process of designing and manufacturing medicines, their transport, administration and disposal throughout the entire life cycle. Safety assessment is a key component of drug development, which ensures the development of effective, quality and safe drugs while supporting broader sustainability goals. A sustainable approach to drug safety emphasizes the reduction of animal testing through the adoption of New Approach Methodologies (NAMs) such as in vitro models, computational toxicology, and artificial intelligence-based predictive tools. Validated in silico methods are of particular importance, as they are extensively used not only for designing intelligent testing strategies but also for predicting toxicity in regulatory contexts. Environmental considerations are also increasingly important. Safety assessments evaluate the potential ecological effects of pharmaceutical compounds, including their persistence, bioaccumulation, and toxicity in ecosystems. This supports the development of greener medicines and reduces environmental contamination. Integrating drug safety assessment with sustainable development principles supports responsible innovation, protects human and environmental health, and contributes to achieving global sustainability objectives, including those outlined in the SDGs.