Table 2.
Number | Core Recommendations | Totala |
---|---|---|
9 | Foster innovation in clinical trials | 35 |
18 | Promote use of high-quality real-world data (RWD) in decision making | 30 |
17 | Reinforce patient relevance in evidence generation | 26 |
15 | Contribute to HTAs' preparedness and downstream decision making for innovative medicines | 25 |
1 | Support developments in precision medicine, biomarkers, and “omics” | 23 |
11 | Expand benefit-risk assessment and communication | 22 |
2 | Support translation of Advanced Therapy Medicinal Products cell, genes, and tissue-based products into patient treatments | 17 |
5 | Create an integrated evaluation pathway for the assessment of medical devices, in vitro diagnostics, and borderline products | 16 |
7 | Diversify and integrate the provision of regulatory advice along the development continuum | 16 |
29 | Leverage collaborations between academia and network scientists to address rapidly emerging regulatory science research questions | 16 |
13 | Optimize capabilities in modeling and simulation and extrapolation | 15 |
16 | Bridge from evaluation to access through collaboration with Payers | 13 |
10 | Develop the regulatory framework for emerging digital clinical data generation | 13 |
31 | Disseminate and share knowledge, expertise, and innovation across the regulatory network and to its stakeholders | 12 |
4 | Facilitate the implementation of novel manufacturing technologies | 12 |
28 | Develop network-led partnerships with academia to undertake fundamental research in strategic areas of regulatory science | 11 |
12 | Invest in special population initiatives | 10 |
25 | Promote global cooperation to anticipate and address supply challenges | 10 |
19 | Develop network competence and specialist collaborations to engage with big data | 10 |
14 | Exploit digital technology and artificial intelligence in decision making | 10 |
3 | Promote and invest in the Priority Medicines scheme (PRIME) | 9 |
6 | Develop understanding of and regulatory response to nanotechnology and new materials' utilization in pharmaceuticals | 6 |
24 | Continue to support development of new antimicrobials and their alternatives | 6 |
30 | Identify and enable access to the best expertise across Europe and internationally | 5 |
8 | Leverage novel non-clinical models and 3Rs | 5 |
22 | Further develop external communications to promote trust and confidence in the EU regulatory system | 4 |
26 | Support innovative approaches to the development and post-authorization monitoring of vaccines | 4 |
20 | Deliver real-time electronic Product Information (ePI) | 3 |
21 | Promote the availability and uptake of biosimilars in health care systems | 2 |
27 | Support the development and implementation of a repurposing framework | 0 |
23 | Implement EMA's health threats plan, ring-fence resources and refine preparedness approaches | 0 |
Total times chosen as first, second, or third most important.