The impact of active pharmaceutical ingredients (APIs) in the environment remains unclear. There are approximately 1900 APIs in use, yet the environmental risks have been assessed for only a fraction of these. To address this gap, the PREMIER project will deliver a novel assessment system for characterizing the environmental risks of APIs.

The PREMIER project aims to develop a comprehensive assessment system dedicated to characterizing the environmental risks of APIs, including their human metabolites and environmental transformation products. This innovative system is designed to fulfill several key objectives, including the screening and prioritization of existing APIs, identification of potential hazards linked to APIs in development, and the enhancement of accessibility to pertinent environmental data for all stakeholders.

Key Objectives:

1. Design Decision Trees: Collaborate with key stakeholders to create decision trees for the prioritization, environmental assessment, targeted testing, and greener design of APIs.
2. Development of Experimental and Modeling Tools: Create novel experimental and modeling tools to estimate the fate properties of APIs and assess the exposure of aquatic and terrestrial environments at high spatial resolutions.
3. In Silico and In Vitro Tools: Develop reliable in silico and in vitro tools to predict environmental effects of APIs on aquatic and terrestrial organisms, supporting the protection of ecologically relevant species and minimizing animal testing.
4. Database Creation: Establish a transparent, publicly accessible database containing information on the occurrence, fate, and effects of APIs in aquatic and terrestrial systems. Include data on API properties and pharmacology to facilitate evidence-based communication among stakeholders.
5. Integration of Tools and Database: Integrate decision trees, exposure and effect tools, and the developed database into an API information and assessment system. Ensure usability by diverse stakeholder groups and provide guidance on prioritization, risk assessment, and support for green API design.
6. Demonstration and Optimization: Collaborate with stakeholders to demonstrate and optimize the system through case studies focused on approximately 25 prioritized APIs. This collaborative approach aims to refine the assessment system based on real-world scenarios and feedback.

The PREMIER project represents a pivotal step towards addressing the environmental risks associated with pharmaceuticals. By combining innovative tools, stakeholder collaboration, and real-world case studies, PREMIER endeavors to deliver a robust and adaptable assessment system. This system will not only prioritize and assess existing APIs but also contribute to the development of greener pharmaceuticals, fostering a more sustainable future for the pharmaceutical industry.