The European medicines regulatory network (EMRN) represents a unique response to the challenge of regulating human and veterinary medicines across a diverse group of countries. It includes the national competent authorities (NCAs) of the 27 EU Member States plus those of Iceland, Liechtenstein and Norway, and also come together under the aegis of the Heads of Medicines Agencies (HMA) and the centralised regulator and coordinating body, the European Medicines Agency (EMA). By working together under a common and agreed set of regulations and laws, and sharing resources, knowledge and expertise to maximise efficiency, they have created one of the world’s leading systems for regulating medicines. Such a complex enterprise inevitably requires detailed planning and coordination. In 2015, the HMA and EMA came together to look ahead and develop an overarching European Medicines Agencies Network strategy for the coming 5 years, addressing 4 key priority areas (supporting development and availability of medicines for human health; increasing availability of veterinary medicines and reducing the risks of veterinary antimicrobial use; optimising the operation of the Network itself; and continuing to develop resource sharing and regulatory convergence at the global level). Building on the success of this previous strategy and the work carried out under its auspices, HMA and EMA are now planning for the next 5 years the European medicines agencies network strategy 2025 document outlining six strategic focus areas:
- Availability and accessibility of medicines
- Data analytics, digital tools and digital transformation
- Innovation
- Antimicrobial resistance and other emerging health threats
- Supply chain challenges
- Sustainability of the Network and operational excellence
A Public Consultation was launched to collect comments from stakeholders and the public, which will be analysed and considered in the final draft of the document. TEDDY provided its comments underlining the necessity to pay attention to paediatric medicines, given the lack of appropriate formulations for children and the difficult early access on innovative and advanced therapies. Likewise, it offered its full support by virtue of its experience in the promotion of paediatric research and ELSI aspects, in compliance with fundamental and children rights. TEDDY suggested concrete actions that could support EMA/HMA network activities, such as the use of the TEDDY- European Paediatric Medicines Database (EPMD) collecting verified information on medicines available for children.