EFPIA statement on the European Regulatory Network Strategy to 2025
EFPIA welcomes the European medicines regulatory agencies network (EMRN) draft strategy to 2025 (EUNS 2025) and fully supports the establishment of an overarching strategic plan. EFPIA views the EUNS 2025 and the related EMA’s Regulatory Science Strategy to 2025 (RSS 2025) as essential to bringing the promising next wave of innovation to patients who live with the burden of unmet medical need.
The all-encompassing nature of EUNS 2025 leads EFPIA to believe that there needs to be a prioritisation of objectives based on EMRN’s core mission and competencies. As a high-level strategic document, the EUNS 2025 must be supported by a prioritised implementation plan with clear actions and measurable deliverables that are monitored annually with progress shared with stakeholders.
Consistent with EFPIA’s own reflection on European regulatory evolution, the Regulatory Road to Innovation, EFPIA proposes four priority actions with measurable outcomes:
- Escalate work on Innovative clinical trials from an EUNS 2025 objective to a theme or goal
- Redesign a more iterative, flexible, integrated product support mechanism
- Implement a Real World Evidence (RWE) use cases/pilot programme
- Develop and implement an overarching EU Telematics Strategy within EUNS 2025 to enable digital transformation
In addition to these concreate measures, EFPIA believes that the creation of a new standalone goal to emphasize patient focus would be important and should be considered. For example, adding considerations to advance patient-focused medicines development could be added under the Innovation theme.
Reflecting the numerous, diverse elements in the EUNS 2025 and its importance, EFPIA would like to highlight the importance of a continuous dialogue with relevant stakeholders to strengthen the EMRN and encourage innovation. EFPIA and its member companies stand ready to engage in that dialogue and our full response to the EUNS 2025 consultation can be found here.