Joint strategy sets direction for EMA and EU medicines regulatory agencies to 2025
The strategy details how the European medicines regulatory network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats, such as the COVID-19 pandemic.
“The COVID-19 pandemic has highlighted the pivotal role of medicine regulation for the protection of public health,” said Emer Cooke, EMA’s Executive Director. “Lack of availability of medicines, either because they are not marketed or due to supply disruptions, has shown to pose serious threats to patient and animal health, animal disease control programs and sustainable livestock production. This strategy ensures that we join forces across the EU to effect tangible improvements for citizens.”
The European medicines agencies network strategy to 2025 outlines six priority areas for the network:
- the availability and accessibility of medicines;
- data analytics, digital tools and digital transformation;
- antimicrobial resistance and other emerging health threats;
- supply chain challenges; and
- the sustainability of the network and operational excellence.
It identifies strategic goals for each of these areas, which will be translated into concrete actions in the detailed work plans of EMA and the national competent authorities in EU Member States in the coming five years. It also considers some of the recent developments related to the COVID-19 pandemic. Further learnings from the pandemic have been incorporated into the strategy and will be taken into account in subsequent work plans on an ongoing basis.
“We must keep pace with societal changes and developments so that we can continue to fulfil our mission successfully, with the most efficient use of the resources and knowledge available to us,” said Thomas Senderovitz, Chair of the Heads of Medicines Agencies Management Group. “This strategy document, which is a living document, will help us to work together across the network to achieve this goal.”
The joint EMA//HMA strategy was open for public consultation from July to September 2020. The extensive and helpful feedback from the public consultation, which captured input from a full range of stakeholder groups, was carefully analysed and reviewed in order to refine and finalise the strategy. More detail on the comments received and the network’s analysis of these comments is available in a separate document .
The European medicines agencies network strategy was developed in consultation with the European Commission and the key themes are aligned with those covered in the Commission’s Pharmaceutical Strategy that will set the tone of future pharmaceutical policy for human medicines in the EU.
The network will review the strategy after 18 months to consider if the goals and objectives remain appropriate, and to adjust them if necessary, in the light of the changing environment and ongoing engagement with stakeholders.
- The development of the European medicines agencies network strategy to 2025 was also informed by the Agency’s Regulatory Science Strategy to 2025 which was published in March 2020.
- The key topic areas and challenges identified in the strategy were presented and discussed with patient, consumer and healthcare professional organisations in March 2020 and industry, academia and veterinary stakeholders contributed through a written consultation.