HPRA publishes 2024 Annual Report

The HPRA today published its 2024 annual report, detailing a wide-ranging programme of work undertaken to regulate health products in Ireland for the benefit of people and animals. The report outlines the HPRA’s core priorities and key achievements throughout the year, while also highlighting its proactive response to external developments affecting the broader health landscape. These included challenges around medicines availability, changes to national and EU regulatory systems, and the detention of unauthorised or illegal medicinal products. 

During 2024, the HPRA’s key activities included:

• Authorisation of 462 new human medicines following an assessment of their safety, quality and effectiveness. 
• Issuing 82 authorisations for clinical trials of human medicines under the EU Clinical Trials Regulation. 
• The continued assessment of the safety, quality and effectiveness of new veterinary medicines. At year-end, there were 1,977 authorised veterinary medicines on the Irish market.
• Review of applications to conduct clinical investigations of medical devices in
• Ireland under the new device regulations including 11 new applications, 17 amendments to ongoing investigations and 11 post-marketing clinical investigations.
• Receipt of 7,885 suspected adverse reaction reports for human medicines. 
• Assessment of 3,672 medical device vigilance reports. 
• Recall of 51 medicines consisting of 46 human medicines and five veterinary medicines. 
• Commencement of 403 market surveillance cases in respect of medical devices. 
• Completion of 83 good manufacturing practice (GMP) inspections at sites that produce human medicines or active substances. There were eight GMP inspections of manufacturers producing veterinary medicines.
• Detention of 1,000,984 dosage units of fake (falsified) and other illegal medicines. A total of 2,553 websites, webpages, e-commerce listings and/or social media pages associated with the sale of falsified or illicit medicinal products were either amended or shutdown. 
• Commencement of 176 market surveillance cases for cosmetic products.

The HPRA continued its active contribution at an EU and international level throughout 2024 including:

• Assessment of 13 new human medicines applications – eight as rapporteur and five as co-rapporteur – via the centralised authorisation procedure coordinated by the European Medicines Agency (EMA). The HPRA was also the co-ordinator of 72 EMA scientific advice requests across a broad range of conditions.
• Serving as rapporteur or co-rapporteur in respect of 10 veterinary medicines that were authorised via the EU centrally authorised route and acting as co-ordinator or joint co-ordinator for six EMA scientific advice procedures relating to veterinary medicines. 
• Serving as rapporteur for the monitoring of any safety signals detected in relation to 70 centrally authorised human medicines through our participation at the EMA Pharmacovigilance Risk Assessment Committee.
• Progressing implementation and application of EU device Regulations for both medical devices and in vitro diagnostic medical devices. This included participation in the EU Medical Device Coordination Group (MDCG) with a focus on priority areas such as safetyand access to critical devices.
• Continuing to play a pivotal role in the IncreaseNET Joint Action. This three-year initiative, co-funded by the EU4Health Programme, aims to bolster the capacity and capability of European national medicines agencies.

Dr Lorraine Nolan, Chief Executive of the HPRA, described 2024 as a year of strategic progress and forward planning, aimed at strengthening the organisation’s ability to deliver on its public health mission.

“The availability of safe and effective medicines remained a key focus at both a national and European level in 2024 as we continued to face global challenges related to medicines supply. Despite these pressures, we made significant strides in strengthening systems designed to reduce the impact of medicine shortages on patients and healthcare providers. For example, in collaboration with the EMA and our partners in the Heads of Medicines Agencies (HMA) network, we contributed to the development of the European Shortages Monitoring Platform. This initiative enhances real-time data sharing and coordination across EU Member States. Actions like these, carried out through the European medicines regulatory network and complemented by strong engagement with national health system partners, continue to strengthen our ability to anticipate, prevent, and mitigate disruptions in the supply of medicines.

“Throughout 2024, we remained strategically focused on enhancing our information resources and communication platforms. Central to this effort was the continued development of the HPRA’s new website, representing a major cross-organisational initiative. The newly designed and restructured site went live in early 2025, marking a key milestone in the HPRA’s Digital Transformation Strategy. Recognising the website as a vital tool for communication and stakeholder engagement, the redevelopment focused on modernising its design, enhancing content readability and accessibility, and improving integration with internal digital systems.

According to Dr Nolan, the HPRA maintained a strong presence at EU level throughout 2024, making substantial contributions across all regulated product areas. A particular highlight, especially noteworthy in light of the recent retirement of Dr Gabriel Beechinor who served as Director of Veterinary Sciences, was the HPRA’s status as the leading national competent authority in the EU for non-centralised assessment work related to veterinary medicines. This included serving as lead Member State for the assessment of 34 applications under the decentralised procedure.

“The HPRA is deeply indebted to Gabriel for his remarkable contribution over more than 37 years,” Dr Nolan said. “The exceptional output delivered by Gabriel and his team in 2024 is a testament to his enduring legacy, which has firmly established the HPRA as a leading European authority in veterinary medicines regulation. On behalf of his colleagues and friends at the HPRA, I extend our heartfelt thanks and best wishes for a fulfilling retirement.”

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

For further information

Káno Communications Tel: (01) 679 8600  

Siobhán Molloy / Sinead Brassil / Eoghan Dowling (086) 817 5066 / (083) 450 5356