The European Medicines Agency will hold a public stakeholder meeting to present the work plan of the 3Rs Working Party (3RsWP) for the 2026–2028 period. The virtual session is scheduled for 31 March 2026 and will focus on initiatives aimed at advancing alternatives to animal testing in the development and evaluation of medicinal products.
The meeting will bring together regulators, pharmaceutical companies, research institutions, and scientific experts involved in regulatory science and non-clinical research. Participants will review the strategic priorities of the working party and discuss upcoming activities designed to support innovation in medicines development while maintaining regulatory standards for safety, quality, and efficacy.
Role of the 3Rs Working Party
The 3Rs Working Party operates within the scientific framework of the European medicines regulatory network and promotes the principles of replacement, reduction, and refinement of animal use in research.
These principles are increasingly integrated into regulatory evaluation processes during non-clinical testing and early drug development. The working party contributes scientific expertise to discussions on alternative testing strategies and emerging scientific methodologies that may reduce reliance on animal studies.
Developments in this area may influence regulatory expectations and research approaches across the pharmaceutical product lifecycle, particularly in early safety evaluation and clinical development planning.
Focus of the 2026–2028 Work Plan
The upcoming work plan outlines activities aimed at strengthening the integration of alternative testing strategies into regulatory science. These initiatives include collaboration with regulatory authorities, academic institutions, and industry stakeholders to support the adoption of new approach methodologies and other innovative scientific tools.
The programme also promotes knowledge exchange across the European regulatory network and encourages dialogue on emerging scientific approaches used in non-clinical evaluation and medicines research.
Regulatory professionals, clinical research teams, and pharmacovigilance specialists often monitor these developments as they may influence regulatory documentation, safety evaluation frameworks, and long-term development strategies.
Relevance for Regulatory and Pharmacovigilance Professionals
Updates related to non-clinical testing strategies and regulatory science are particularly relevant for pharmaceutical companies and CROs involved in drug development and regulatory compliance.
Organizations working in regulatory affairs, clinical research, and pharmacovigilance frequently monitor initiatives from the European Medicines Agency to align internal procedures, risk management activities, and regulatory documentation with evolving expectations.
Additional information about global pharmacovigilance practices and safety monitoring can be found in Baupharma’s pharmacovigilance services page:
https://www.baupharma.com/services-categories/pharmacovigilance/
Insights into pharmacovigilance system management and regulatory documentation are discussed in:
https://www.baupharma.com/blogs-posts/psmf-maintenance-concept-importance-pharmacovigilance/
Summary
The upcoming public session organized by the European Medicines Agency will present the strategic priorities of the 3Rs Working Party for the 2026–2028 period. The initiative supports collaboration between regulators, industry stakeholders, and research institutions while encouraging the development of alternative scientific approaches in non-clinical testing and medicines research.
For more information: 3Rs Working Party (3RsWP) stakeholder meeting - Public session on the 2026-2028 work plan
