Table 3.
Overall comparison of all Core Recommendations by mean score (question 7).
| Number | Core Recommendations | Mean score |
|---|---|---|
| 9 | Foster innovation in clinical trials | 4.4 |
| 17 | Reinforce patient relevance in evidence generation | 4.4 |
| 18 | Promote use of high-quality real world data (RWD) in decision making | 4.4 |
| 15 | Contribute to HTAs' preparedness and downstream decision making for innovative medicines | 4.3 |
| 2 | Support translation of Advanced Therapy Medicinal Products cell, genes, and tissue-based products into patient treatments | 4.3 |
| 30 | Identify and enable access to the best expertise across Europe and internationally | 4.3 |
| 10 | Develop the regulatory framework for emerging digital clinical data generation | 4.3 |
| 31 | Disseminate and share knowledge, expertise, and innovation across the regulatory network and to its stakeholders | 4.3 |
| 24 | Continue to support development of new antimicrobials and their alternatives | 4.2 |
| 28 | Develop network-led partnerships with academia to undertake fundamental research in strategic areas of regulatory science | 4.2 |
| 1 | Support developments in precision medicine, biomarkers, and “omics” | 4.2 |
| 11 | Expand benefit-risk assessment and communication | 4.2 |
| 29 | Leverage collaborations between academia and network scientists to address rapidly emerging regulatory science research questions | 4.2 |
| 7 | Diversify and integrate the provision of regulatory advice along the development continuum | 4.1 |
| 19 | Develop network competence and specialist collaborations to engage with big data | 4.1 |
| 5 | Create an integrated evaluation pathway for the assessment of medical devices, in vitro diagnostics, and borderline products | 4.1 |
| 25 | Promote global cooperation to anticipate and address supply challenges | 4.1 |
| 14 | Exploit digital technology and artificial intelligence in decision making | 4.0 |
| 26 | Support innovative approaches to the development and post-authorization monitoring of vaccines | 3.9 |
| 13 | Optimize capabilities in modeling and simulation and extrapolation | 3.9 |
| 16 | Bridge from evaluation to access through collaboration with payers | 3.9 |
| 22 | Further develop external communications to promote trust and confidence in the EU regulatory system | 3.9 |
| 12 | Invest in special populations initiatives | 3.8 |
| 4 | Facilitate the implementation of novel manufacturing technologies | 3.8 |
| 20 | Deliver real-time electronic Product Information (ePI) | 3.8 |
| 3 | Promote and invest in the Priority Medicines scheme (PRIME) | 3.8 |
| 8 | Leverage novel nonclinical models and 3Rs | 3.7 |
| 23 | Implement EMA's health threats plan, ring-fence resources, and refine preparedness approaches | 3.7 |
| 6 | Develop understanding of and regulatory response to nanotechnology and new materials' utilization in pharmaceuticals | 3.6 |
| 27 | Support the development and implementation of a repurposing framework | 3.5 |
| 21 | Promote the availability and uptake of biosimilars in healthcare systems | 3.5 |
Overall mean scores were calculated based on the individual scores given by participants who rated each Core Recommendation on a scale from 1 to 5: (1) not important; (2) less important; (3) moderately important; (4) important; (5) very important.