The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) recently unveiled the new European Medicines Agency Network Strategy to 2028 (EMANS 2028), a document that outlines the priorities for medicines regulation in the European Union in the coming years. This strategy aims to respond to the challenges and needs of the pharmaceutical sector and strengthen the EU’s competitiveness in the development and manufacture of medicines, while ensuring safe and equitable access to innovative treatments.
EMANS 2028 objectives
The strategy, entitled “Seizing opportunities in a changing landscape”, has the main objective of updating the previous plan (2021-2025), placing special emphasis on the use of emerging technologies, such as artificial intelligence and digitalization, which will play an increasing role in the evaluation and monitoring of medicines throughout their life cycle.
The new approach also incorporates One Health, a strategy that recognizes the interconnection between human, animal and environmental health, aiming for a coordinated response to global challenges.
Six Priority Areas of the Strategy
EMANS 2028 defines six priority areas that will guide medicines regulation actions in the EU until 2028. These are the most urgent and fundamental areas of action for the future development of the regulatory network:
- Accessibility: Facilitating access to medicines through EU health systems.
- Digitalization and Artificial Intelligence: Improving decision-making, optimizing processes and increasing efficiency.
- Innovation and Competitiveness: Creating a regulatory environment that fosters research and the rapid translation of innovation into benefits for patients.
- Preparedness for Health Threats: Strengthening the capacity to respond to emergencies, including antimicrobial resistance.
- Availability and Security of Supply: Ensuring a stable supply of medicines and the security of supply chains.
- Sustainability of the Regulatory Network: Ensure the necessary resources to support scientific and regulatory decisions, taking advantage of technological advances.
Importance of the Medicines Regulation Strategy
Maria Lamas, President of the HMA Management Group, highlighted the importance of the strategy to ensure “a transparent and future-oriented approach to the management of public health priorities”. She emphasized that European regulatory agencies must operate with a comprehensive strategy, capable of adapting to new opportunities to promote public and animal health.
EMANS 2028 will also be implemented according to multi-annual work plans, allowing for continuous monitoring of its implementation and adjustments as necessary.
Infarmed’s role in drawing up the strategy
Infarmed, the Portuguese authority responsible for regulating medicines and health products, played an active role in drawing up EMANS 2028. The institution’s president, Rui Santos Ivo, was part of the document’s coordination team, representing the HMA together with Thomas Hereber from BVL (Germany). Infarmed also co-led the Availability and Security of Supply theme, working with other experts from different EU countries.
Rui Santos Ivo highlighted the importance of the strategy in responding to global regulatory challenges and preparing for the revision of European pharmaceutical legislation, especially with regard to access to and availability of medicines.
Next steps and implementation
With the adoption of EMANS 2028, the EMA and the HMA will now implement the strategy, adapting it to the needs of the sector and monitoring its implementation on an ongoing basis. International collaboration will be essential to guarantee the effectiveness of the strategy and to ensure that the network of European regulatory agencies is prepared to face the challenges of the next decade.
This initiative not only puts the EU at the forefront of pharmaceutical regulation, but also ensures that European citizens can access safe and innovative medicines, thus promoting public health in a sustainable and equitable way.
