The HPRA’s latest annual report outlines a number of areas of focus, with medicine availability still a top priority
The Health Products Regulatory Authority (HPRA) has published its 2023 annual report, which details its activities across an extensive range of work programmes to regulate medicines, medical devices and other health products for the benefit of people and animals.
The report outlines the HPRA’s core focus and achievements in each of the health product areas it regulates. It also details the organisation’s tailored and effective response to external developments that impacted on the wider health sector.
During 2023, the HPRA says key activities undertaken included:
- The authorisation of 384 new human medicines following an assessment of their safety, quality and effectiveness.
- 19 new clinical trial authorisations under the EU Clinical Trials Directive (CTD) and 36 authorisations under the new EU Clinical Trials Regulation (CTR).
- Continued assessment of the safety, quality and effectiveness of new veterinary medicines. At year-end, there were 1,913 authorised veterinary medicines on the Irish market.
- Receipt of 7,793 suspected adverse reaction reports for human medicines.
- Receipt of adverse event reports relating to veterinary medicines directly from veterinarians and animal owners. Overall, there were 852 reports which also included reports from marketing authorisation holders recorded in the European Pharmacovigilance Database.
- Assessment of 3,065 medical device vigilance reports.
- Recall of 65 medicines consisting of 59 human medicines and six veterinary medicines.
- Commencement of 317 market surveillance cases in respect of medical devices.
- Completion of 103 good manufacturing practice (GMP) inspections at sites that produce human medicines or active substances. There were three GMP inspections of manufacturers producing veterinary medicines.
- Commencement of 204 market surveillance cases for cosmetic products.
- Detention of 874,945 dosage units of fake (falsified) and illegal medicines. A total of 2,348 websites, e-commerce listings and social media pages associated with the sale of falsified/illicit medical products were either amended or shutdown.
Milestones
Dr Lorraine Nolan, Chief Executive of the HPRA, said 2023 brought many opportunities, milestones and challenges for the organisation which at all times, and across all its operations and decision-making, maintained a clear, central focus on seeking to protect consumer and animal health.
“Medicine availability continues to be a top priority for the HPRA and our partners across the Irish health system. Over the course of 2023, all EU member states, and many countries globally reported an increased prevalence of medicines shortages, indicating this is by no means an issue that is unique to Ireland. We recognise and appreciate the issues that medicines shortages pose for patients and healthcare professionals, and this is central to our efforts to prevent and mitigate against shortages. As coordinator of the national Medicines Shortages Framework, the HPRA continues to collaborate with all stakeholders who have a part to play in reducing the impact of medicines shortages for Irish patients, including ensuring access to suitable alternative treatments, where possible. At EU level, the HPRA also actively contributes to numerous initiatives to address shortages and will continue to work towards our shared goal of strengthened medicines supply within Europe.”
The HPRA’s active contribution at an EU and international level during 2023 included:
- Serving as one of the top 10 national contributors via the European Medicines Agency (EMA) for lead assessment of centrally authorised human medicines and scientific advice, as was also the case last year. This included the assessment of 12 new human medicines applications – eight as rapporteur and four as co-rapporteur – and the co-ordination of 93 scientific advice procedures.
- The HPRA acted as rapporteur or co-rapporteur in respect of eight veterinary medicines that were authorised via the EU centrally authorised route and acted as co-ordinator or joint co-ordinator for five EMA scientific advice procedures relating to veterinary medicines. Separately, for procedures outside of the centrally authorised route, the HPRA was the second-leading national competent authority in the EU for outgoing work relating to veterinary medicines. This included acting as reference (lead) Member State (RMS) for the assessment of 21 applications under the decentralised procedure.
- Contributed to the effective application of the EU Medical Device Regulation and in vitro Device Regulation at EU and national levels, gathering data on the challenges with implementation while working to ensure continued supply of essential devices.
- Continued to co-lead an International Coalition of Medicines Regulatory Authorities (ICMRA) project piloting global assessments of post-approval change management protocols for innovative medicines.
Innovation
“Supporting innovation was also a key priority for the HPRA throughout 2023, in line with our current strategic plan,” Dr Nolan continued. “We were honoured to host the EU-Innovation Network conference in November, which focused on supporting life sciences innovation across Europe and brought together key stakeholders to explore challenges faced by innovators. The discussions highlighted the importance of continued regulatory agility to respond to both scientific and technological advancements to enable swift access to products to benefit human health.”
Dr Nolan concluded that the HPRA’s Innovation Office continues to offer regulatory advice to anyone developing an innovative heath product or technology. Approximately 70 per cent of queries received by the innovation office emanated from small and medium enterprises, and academia, she said.
