WP1: In collaboration with EMA and WP1 partners, RU developed a decision tree to prioritise legacy APIs for environmental risk assessment (ERA), now being finalised. EFPIA and public partners scheduled and began experimental tests for 25 case study APIs, with results enabling final ERA in RP6.
WP2: Major advances were made, including a new approach to experimentally measure and predict half—lives in soil and water-sediment systems through read-across has been developed. Simplified machine learning-based approach was developed and applied for assessing sorption mobility of APIs in the environment. An aquatic secondary poisoning model was developed and validated for aquatic food webs. The ePiE model (
https://shoeks.github.io/ePiE_desktopApp/(se abrirá en una nueva ventana)) was expanded and evaluated using an extensive European monitoring set. The EcoDrug+ database (
https://ecodrugplus.helsinki.fi/(se abrirá en una nueva ventana)) is finalised. The VERA model (
https://www.vegahub.eu/download/(se abrirá en una nueva ventana)) was improved for acute/chronic fish toxicity, and new QSAR models were developed to assess the acute toxicity of earthworms. Integration of effect modelling tools into the DAS progressed, with new data generated for API uptake and clearance, and predictive methods for API effects in fish. Multiple journal articles resulted from WP2.
WP3: WP3 enhance the PREMIER ERA Database and Digital Assessment System (DAS) across three sub-WPs. WP3.1 focused on database design and population, adapting based on partner feedback and DAS testing, including an EU-wide API inventory and GLP study data. WP3.2 systematically extracted and assessed literature and regulatory data for case study compounds, evaluating data reliability and conducting comprehensive assessments for 25 APIs. WP3.3 defined and improved DAS functionalities, enhancing search capabilities and refining ERA tool architecture per EMA guidelines, preparing DAS for public access in RP6.
WP4: Guidance documents 1–4 are in advanced draft stages, with annexed example calculations for clozapine and metoprolol. Guidance 4 addresses selecting environmental threshold concentrations, with a scientific article nearly ready for review. Guidance 8 for drug R&D experts will be published as a brochure. Guidance 1, 3, and 4 are slightly delayed (D4.4) while guidance 2 on exposure assessment will be delivered as D4.3. D4.8 with conclusions on greener drug design, has been submitted, and an interview-based article is nearing completion. D4.7 and its manuscript, covering new drug modalities and their environmental impact, are delayed.
WP5: RP5 focused on robust project governance and management, coordinating all scientific and operational activities. This included strategic oversight, engaging the SAB, supporting the PMO, ExCom, and GAMs. Virtual GAM#10 and onsite GAM#11 in Barcelona (September 2025) were organised. WP5 maintained oversight of deliverables, milestones, and risk management, with regular meetings and continuous editorial communication. Efforts enhanced internal/external communications, including two newsletters and targeted social media posts. Commitment to open-source development ensures long-term PREMIER outcomes, especially the DAS. Increasing EMA involvement supports EU platform compatibility, strengthening DAS relevance and accessibility.
