EMA and the Heads of Medicines Agencies (HMA) have developed a joint strategy for the next five years that is released for a two-month public consultation today. The draft strategy details how the European medicines agencies’ 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 European Medicines Agencies Network Strategy to 2025, which builds on the HMA/EMA strategy to 2020, outlines six priority areas for the network:
the availability and accessibility of medicines;
data analytics, digital tools and digital transformation;
innovation;
antimicrobial resistance and other emerging health threats;
supply chain challenges; and
the sustainability of the network and operational excellence.
It identifies high-level goals and supporting recommendations for each of these areas, which will guide and shape the detailed work plans of EMA and the national competent authorities in EU Member States in the coming five years.
Input on the draft strategy document is welcome from all stakeholders, including members of the public, until 4 September 2020 via an online questionnaire.
The draft strategy was developed in consultation with the European Commission (EC) and the key themes are aligned with those covered by the EC’s roadmap for a new Pharmaceutical Strategy. It also takes into account some of the recent developments related to the COVID-19 pandemic. Further learnings from the pandemic will be incorporated into the strategy and subsequent work plans on an ongoing basis.
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.
Launch of public consultation on joint network strategy to 2025
The strategy is intended to be a living document which will be periodically reviewed, and detailed actions to implement it will be further developed by EMA and the national authorities in their multi-annual work plans. For most of these actions the work will be shared between national authorities and EMA and will involve close collaboration.
Following the public consultation, comments from stakeholders and the public will be analysed and considered in the final draft of the document.
The strategy will be considered for adoption by the HMA and EMA Management Board towards the end of 2020. A summary of comments will be published at the time of publication of the final strategy.
Notes
The development of the European Regulatory Network Strategy to 2025 was also informed by the Agency’s Regulatory Science Strategy to 2025 which was published in March 2020.
Contact point
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E-mail: press@ema.europa.eu
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Heads of Medicines Agencies Permanent Secretariat
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63225 Langen
Germany
E-mail:hma-ps@pei.de
