HPRA to support Ireland’s EU Council Presidency

15/07/2026 Regulatory news Corporate news

Logo of the Irish Presidency of the EU

The HPRA will actively contribute to Ireland’s Presidency of the Council of the European Union from July to December 2026. We will support Ireland’s Permanent Representation in Brussels and the Department of Health to make significant progress on key legislative files. These measures include the revision of the Medical Devices and In Vitro Diagnostics Regulations, as well as the Biotech Act, which proposes amendments to a number of EU health product regulations, most notably the Clinical Trials Regulation. These legislative proposals aim to support efficient regulatory processes to make Europe an attractive location for developing innovative health products, while maintaining the highest standards of quality, safety and public health protection.

As Ireland’s national regulator for medicines and medical devices, the HPRA will host 25 meetings involving delegates from all EU Member States. These meetings will support the Irish Government’s health priorities during the Presidency, helping to shape and implement regulatory frameworks that support the safety of medicines and medical devices across Europe. 

In addition to the legislative priorities outlined above, the HPRA will contribute to a broad range of regulatory objectives. Through its programme of meetings, the HPRA will support progress across the following areas:  

  • Competitiveness – fostering a regulatory environment that protects public and animal health while supporting research, innovation and investment in the European life sciences sector 
  • Access – promoting equitable access to safe and effective health products for patients across the EU 
  • Clinical research – enabling clinical research by supporting innovators and researchers to understand and navigate regulatory requirements  
  • Medicine supply – implementing the Critical Medicines Act and strengthening the security and resilience of medicine supply across Europe 
  • Digital health – responding to significant developments including artificial intelligence; working to implement the European Health Data Space Regulation; and developing digital solutions to support regulatory processes. 

Ms Grainne Power, Chief Executive of the HPRA, welcomes EU delegates to Dublin, saying:  

“The European regulatory network plays a vital role in facilitating collaboration and enabling the sharing of expertise and resources, helping to deliver effective and efficient regulation across Europe. As an active member for more than 30 years, the HPRA is proud to contribute to this collective effort and to support even closer collaboration and coordination in the regulation of medicines and medical devices across the EU. We look forward to welcoming delegates from every EU Member State to Dublin for these important meetings and to facilitating productive discussions that help strengthen the European regulatory system and deliver positive outcomes for patients and public health.”

 Mr Paul Quinn, Chairperson of the Authority of the HPRA, added: 

“The HPRA is proud to support the Irish Government’s Presidency programme and contribute its expertise to key legislative and regulatory priorities. Through Ireland’s leadership during the Presidency, we have an opportunity to help shape the future of health product regulation in Europe, ensuring that the regulatory framework continues to protect public health, supports innovation and responds effectively to emerging challenges. In doing so, we will support the Irish Presidency theme of ‘Ní neart go cur le chéile – Strength with unity’, reflecting the importance of partnership, shared expertise and collective action in addressing common challenges across Europe.”

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