OBJECTIVES: Identify insights from reflective MCDA (rMCDA) experiences in Spain representing potential contributions to achievement of European Medicines Agency’s (EMA) regulatory science to 2025 objectives and patient access to medicines in Europe (EU).

METHODS: Meta-analysis of rMCDA (EVIDEM framework) exercises conducted in Spain involving over 150 stakeholders (regulatory, national, regional and hospital evaluators and decision-makers and patient groups) focusing on challenging therapeutic areas: rare diseases and oncology.

RESULTS: rMCDA discussions and conclusions suggest key potential contributions to 4/5 EMA’s regulatory science 2025 strategic goals (SG) and their respective core recommendations (CRs): SG1 Catalysing integration of science and technology in medicines development (CRs: Evaluate in collaboration with HTAs, payers and patients treatment impact in clinical outcomes measured by biomarkers; Promote and invest in the PRIME scheme; Diversify and integrate provision of regulatory advice along the development continuum); SG2: Driving collaborative evidence generation improving the scientific quality of evaluations (CRs: Foster innovation in clinical trials; Develop regulatory framework for emerging clinical data generation; Expand benefit-risk assessment and communication; Invest in special populations initiatives); SG3: Advancing patient-centred access to medicines in partnership with healthcare systems (CRs: Contribute to HTA’s preparedness and downstream decision making for innovative medicines; Bridging from evaluation to access through collaboration with payers; Reinforce patient relevance in evidence generation; Further develop external engagement and communications to promote trust and confidence in the EU regulatory system) and SG5: Enabling and leveraging research and innovation in regulatory science (CRs: Disseminate and exchange knowledge, expertise and innovation across the network and to its stakeholders).

CONCLUSIONS: Application of rMCDA methodology to evaluation and decision-making could be useful to operationalise EMA’s strategic goals to 2025 based on what really matters to key stakeholders, enabling advances in empowerment, enhancing contributions to regulatory science and bridging the gap between regulatory approval and patient access to innovative medicines.