HPRA publishes 2025 annual report

The HPRA today published its 2025 annual report, outlining a year of significant achievement across its regulatory remit and marking the successful conclusion of the organisation's Strategic Plan 2021-2025. The report highlights the HPRA's continued contribution to protecting public and animal health through the regulation of medicines, medical devices and other health products, while responding to a complex and evolving national and European regulatory environment. It also reflects the organisation's role in strengthening Ireland's regulatory capacity, supporting access to safe and effective health products, and contributing to the work of the wider European regulatory network.

During 2025, the HPRA’s key activities included:

• Authorisation of 473 new human medicines following assessment of their safety, quality and effectiveness. 
• Issuing 95 authorisations for clinical trials of human medicines under the EU Clinical Trials Regulation. 
• Continuing the assessment of veterinary medicines, with 1,966 authorised medicines for animal use on the Irish market at year-end. 
• Receipt of 8,565 suspected adverse reaction reports for human medicines. 
• Receipt and assessment 4,638 medical device vigilance reports, in addition to undertaking 564 market surveillance cases.
• Completion of 108 good manufacturing practice (GMP) inspections at sites producing human medicines or active substances, and 11 GMP inspections of veterinary medicines manufacturers. 
• Undertaking 191 market surveillance cases relating to cosmetic products. 
• Coordinating 54 recalls of medicines, comprising 41 human medicines and 13 veterinary medicines. 
• Detention of 763,027 dosage units of falsified and other illegal medicines, while securing the amendment or shutdown of 4,762 websites, e-commerce listings and social media pages associated with the sale of illicit medicinal products. 

The HPRA continued its active contribution at European and international level throughout 2025, including:

• Acting as rapporteur or co-rapporteur for 13 centrally authorised human medicines and being assigned a further seven centralised assessment roles during the year. The HPRA was also the co-ordinator of 54 scientific advice requests via the European Medicines Agency (EMA) across a broad range of conditions.
• Serving as rapporteur or co-rapporteur for six centrally authorised veterinary medicines and acting as co-ordinator or joint co-ordinator for nine EMA scientific advice procedures relating to veterinary medicines.  
• Playing a leading role in European initiatives addressing medicines shortages, including contributions to the European Shortages Monitoring Platform and the EMA Medicines Shortages Steering Group. 
• Contributing to the IncreaseNET Joint Action, which aims to strengthen the capacity and capability of medicines regulators across Europe. 
• Supporting the ongoing implementation of the EU medical device regulations, including leadership roles within the Medical Device Coordination Group and related working groups. 
• Advancing work on innovative health technologies through initiatives such as COMBINE and the EU Innovation Network. 

Grainne Power, Chief Executive of the HPRA, reflected on 2025 as a pivotal year for the organisation.  

“The publication of our 2025 Annual Report marks the conclusion of the HPRA’s Strategic Plan 2021–2025, a period during which the organisation delivered an ambitious programme of work while responding to significant external challenges. Throughout this period, our focus remained firmly on protecting public and animal health with strong collaboration across the Irish and European regulatory systems. 

Ms Power also pointed to 2025 as a year of significant achievement, underpinned by continued investment in the organisation’s people, capabilities and digital infrastructure.

“The availability of medicines remained a priority during 2025, with ongoing global supply pressures highlighting the importance of robust regulatory systems, strong partnerships and coordinated action. Through our contribution to medicines availability initiatives, crisis preparedness activities and regulatory policy development, we continued to strengthen our ability to anticipate, prevent and mitigate potential disruptions for patients and healthcare professionals.

“We completed a highly successful Benchmarking of European Medicines Agencies assessment, continued our participation and influence across the European regulatory network and broader international regulatory initiatives, and launched the new HPRA website as part of our ongoing digital transformation programme. Internally, we introduced a Career and Capabilities Framework for staff and launched a new learning and development platform, further strengthening our capacity to meet future challenges and opportunities.

Ms Power also acknowledged the significant contribution of Dr Lorraine Nolan, whose decade as Chief Executive helped strengthen the HPRA’s regulatory impact, organisational capability and standing both nationally and internationally across Europe.

“As we move into the next phase for our organisation under the HPRA Strategic Plan 2026–2029, we do so from a position of strength. The regulatory environment continues to evolve rapidly, driven by advances in science and technology and by significant updates to national and European regulatory frameworks across health products. The HPRA remains committed to ensuring that Ireland benefits from a trusted, responsive and effective regulator that supports and embraces innovation while safeguarding public and animal health.”

The full report is available to download below. The HPRA Annual Report is also available in Irish. 

ENDS

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