The Report also shows the HPRA’s continued focus on patient safety, supply chain resilience, enforcement and innovation, including medicines and device shortages, increased surveillance and inspection activity, action against non-compliant products, and support for clinical trials and emerging healthcare products.
Background
The Health Products Regulatory Authority (HPRA) recently published its Annual Report for 2025.
The Report reflects a regulatory environment in which companies are managing increasingly complex obligations across the full product lifecycle, from development, clinical trials and market access through to manufacturing, supply, pharmacovigilance, advertising, distribution and post-market enforcement.
The HPRA also continued to contribute to the wider European regulatory network, relevant for businesses using centralised, mutual recognition or decentralised procedures, cross-border clinical trials, European manufacturing operations, or products regulated under the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
Human medicines
The human medicines sector remained the HPRA's largest area of activity in 2025. The regulator authorised 473 new medicines across national, decentralised, mutual recognition and centralised procedures, issued 95 clinical trial authorisations, and coordinated 54 EMA scientific advice procedures, reflecting Ireland’s continued attractiveness for pharmaceutical development and clinical research.
Medicines availability remained a major focus. The HPRA continued to participate in European shortage management initiatives and supported new national measures, including proposals for mandatory shortage notifications and enhanced stock monitoring. The Department of Health's late-2025 establishment of the Strategic Medicines Access and Availability Group reflects the growing policy focus on supply resilience.
The authority also maintained major oversight and enforcement activity: 8,565 adverse reaction reports, 108 GMP inspections, 1,103 quality defect cases and 41 human medicine recalls. Although the volume of falsified or illegal medicines detained fell to just over 763,000 dosage units (down from over 1,000,000 in 2024), enforcement cases initiated rose sharply to 13,898 (up from 4,950 in 2024), and 4,762 websites, online listings and social media pages were amended or shut down for unlawful medicines sales.
Medical devices
Regulatory oversight of medical devices expanded in 2025, with 171 economic operator validations on EUDAMED and 246 new national device organisations registered. The agency supported emerging technologies by reviewing 7 clinical investigations under the MDR and 7 performance studies under the IVDR, and a pilot "hyper care" programme provided pre-submission support for early feasibility studies involving high-risk devices.
Market surveillance and vigilance operations were highly active, resulting in:
- 4,638 vigilance reports assessed
- 564 surveillance cases initiated
- 615 field safety corrective actions managed, and
- 18 formal compliance notifications issued
The HPRA also conducted 32 inspections across manufacturers, notified bodies and distributors.
At policy level, the HPRA co-chaired the Medical Device Coordination Group breakthrough taskforce, producing the EU’s first official guidance on clinical evidence for breakthrough technologies, and implemented new evaluation processes for device shortage notifications under EU Regulation 2024/1860.
Veterinary medicine
The veterinary medicines sector continued to evolve under the EU Veterinary Medicines Regulation framework. At year-end, 1,966 veterinary medicines were authorised in Ireland, with 57 new products approved during 2025 and the HPRA acting as the reference Member State on numerous European procedures.
Pharmacovigilance and product quality remained key priorities, with more than 1,000 adverse event reports relating to Irish products recorded on the European pharmacovigilance database, alongside substantial signal detection activity and continued involvement in EMA working groups.
The Report highlights continued emphasis on antimicrobial stewardship and resistance, with the HPRA collecting and analysing veterinary antimicrobial sales data to support EU reduction targets, alongside product quality surveillance, recalls and manufacturing inspections.
Controlled drugs and precursor chemicals
The HPRA managed the administrative licensing of controlled drugs on behalf of the Department of Health, processing 2,311 licensing activities for the import, export and possession of restricted substances, ensuring scheduled drugs under the Misuse of Drugs Acts are used strictly for legitimate medical and scientific purposes.
Regulatory controls extended to precursor chemicals and agricultural licensing: 15 licensing procedures for precursor chemicals, substances heavily monitored for dual use in pharmaceutical manufacturing and illicit drug synthesis, and 18 one-year licences for legal hemp cultivation.
The HPRA also conducted 28 specialised inspections of controlled drug manufacturers and distributors and supported the Medical Cannabis Access Programme (MCAP) by assessing supplier applications and recommending one new product for inclusion, which the Department of Health accepted, raising approved MCAP products to 11.
Cosmetic products
The cosmetics sector continued to attract increasing regulatory attention, particularly around market surveillance and consumer protection. During 2025, the HPRA issued 131 free sale certificates for export activities and maintained extensive oversight of products on the Irish market.
Market surveillance activity remained robust, with:
- 191 surveillance cases initiated
- 1,667 Safety Gate notifications received, and
- 22 inspections carried out to assess compliance with the EU Cosmetics Regulation
The authority also focused on public awareness and consumer safety. It published research highlighting widespread consumer use of cosmetic products beyond their expiry periods and encouraged greater adherence to product labelling and safety guidance.
Other regulatory programmes
Beyond its core product areas, the HPRA continued to expand its support for regulatory innovation, international cooperation and inspection activities, remaining heavily involved in European and international networks covering GMP, GDP, pharmacovigilance and pharmaceutical quality management.
Through its Innovation Office, the HPRA provided regulatory guidance to developers of innovative products and technologies, with many enquiries from SMEs and academic institutions, while maintaining a leadership position within the EU Innovation Network.
The Report further demonstrates the HPRA’s increasing engagement in policy development, horizon scanning and international regulatory cooperation, aiming to ensure emerging technologies and novel product categories can be regulated effectively while facilitating patient access to innovation.
Impact
The HPRA’s 2025 activities show that regulatory compliance is becoming a more complex and continuous responsibility for businesses across medicines, medical devices, veterinary medicines, cosmetics and related sectors, with obligations spanning the full product lifecycle from development and clinical research through manufacturing, distribution, advertising, pharmacovigilance and post-market surveillance.
The picture is reinforced by developments at EU level expected to take effect over the course of 2026. Businesses should consider the following practical steps:
Strengthen supply chain resilience and shortage-reporting readiness
The HPRA has supported proposals for mandatory shortage notifications and enhanced stock monitoring, and the proposed EU pharmaceutical legislation reform would require shortage prevention plans and earlier notification of withdrawals or supply disruptions. Businesses should review forecasting, sourcing and notification procedures now.
Treat compliance and quality systems as commercial risk management
HPRA enforcement cases initiated rose sharply to 13,898 in 2025, up from 4,950 in 2024. Robust compliance and quality systems reduce enforcement exposure and protect market access.
Audit device vigilance and shortage-notification processes ahead of EU changes
The HPRA has implemented new evaluation processes for device shortage notifications under EU Regulation 2024/1860, which requires manufacturers to notify authorities and health institutions before supply of certain devices or IVDs is interrupted. Manufacturers and distributors should map their notification chains now.
Prepare for the EU Critical Medicines Act and revised pharmaceutical legislation
The Critical Medicines Act will establish a European Critical Medicines Board to identify up to 200 critical medicines and prioritise supply security in procurement, while the pharmaceutical legislation reform, agreed in December 2025, shortens the EMA review period from 210 to 180 days and expands Member State powers during shortages. Track both measures for impact on manufacturing and procurement strategy.
Assess eligibility for innovation and fast-track pathways
The HPRA co-chaired the breakthrough devices taskforce and ran a pilot "hyper care" programme for high-risk device feasibility studies and expanded the MCAP to 11 approved products. Early engagement with the HPRA's Innovation Office can reduce approval timelines.
Conclusion
Taken together, these developments highlight the growing strategic value of strong regulatory capability. Companies with solid compliance frameworks can maintain market access while adapting smoothly to regulatory change. This agility helps bring innovative products to market more efficiently.
For more information, contact a member of our Life Sciences Regulatory team.
The content of this article is provided for information purposes only and does not constitute legal or other advice.
