The draft European Medicines Agencies Network Strategy to 2028 is a timely update to the previous strategy covering 2021 to 2025 (EMANS 2025). This new strategy aims to address the evolving landscape of medicines regulation while ensuring the accessibility of safe and effective medicines within the EU.

Background and Context

The EMA developed the original strategy (EMANS 2025) in response to the rapid changes in the medicines landscape, particularly during the COVID-19 pandemic. Since then, substantial shifts have occurred in both regulatory and technological spheres. This includes new EU legislation for public health emergencies and the establishment of the Directorate-General for Health Emergency Preparedness and Response (DG HERA).

Key Focus Areas

The draft strategy to 2028 is organized around six strategic focus areas:

1. Accessibility: The primary goal is to facilitate pathways for access to medicines through healthcare systems in the EU. This will ensure efficient and predictable access for patients and veterinary medicine users.
2. Leveraging Data, Digitalisation, and Artificial Intelligence: The plan emphasizes making decisions more effective and optimizing processes by integrating technological advancements, especially in AI and digitalisation.
3. Regulatory Science, Innovation, and Competitiveness: A core focus is to foster a regulatory and research environment that enhances innovation and competitiveness within the EU’s healthcare sector. This will help accelerate the translation of new ideas into market-ready medicines.
4. Antimicrobial Resistance and Other Health Threats: There’s a strong commitment to prepare the EU for potential health threats. This includes antimicrobial resistance, ensuring that the network is ready to respond to public health emergencies.
5. Availability and Supply: The strategy aims to bolster the availability of medicines to protect public and animal health. By addressing supply-chain challenges, it seeks to ensure a steady supply of essential medicines.
6. Sustainability of the Network: Ensuring that the network possesses the necessary resources is crucial. This support will enhance the scientific and regulatory decision-making processes, maintaining operational excellence and sustainability.

Consultation and Implementation

An eight-week public consultation for the draft strategy is open until 30 November 2024. The EMA encourages stakeholders to provide feedback via an online questionnaire. Following this consultation, the EMA and will refine the strategy, aiming for adoption by March 2025. Th EMA will implement the finalized strategy through respective multi-annual work plans.

Additional Resources

The EMA published a reflection paper to aid in the consultation process. It offers insights into the considerations and discussions that informed the draft strategy.

In summary, the draft European Medicines Agencies Network Strategy to 2028 is designed to align the regulatory framework with the dynamic landscape of medicine regulations. By leveraging new technologies and addressing health threats, the strategy ensures that the continued accessibility of safe and effective medicines remains a priority across the EU.