End of Year Review: HPRA

This year has seen significant progress in several key areas of focus for the HPRA as we continued our work in response to the pandemic in combination with ongoing activities to ensure the successful implementation of new regulations and management of medicines shortages.

Written by Dr Lorraine Nolan, Chief Executive, Healthcare Products Regulatory Authority

Central to the success of all these initiatives continues to be close collaborative relationships with all our partners across the broader healthcare system. Indeed, maintaining and establishing new collaborative partnerships with key stakeholders will continue to be a primary focus for the organisation into 2023 as we look to enhance and protect public health through the effective regulation of health products.

COVID-19 Response and Lessons Learned

There is no doubt that 2022 was a much more positive and optimistic time for our country following the challenges presented by the COVID-19 pandemic during the previous almost two-year period. While there are currently no COVID-19 restrictions in Ireland, public health advice, combined with safe and effective vaccines, continue to help protect our communities. As we enter a new phase in our response to COVID-19, it is important we remain vigilant given the potential for future waves of infections driven by different subvariants. From a regulatory perspective, there was considerable focus on the authorisation of adapted bivalent vaccines to help protect against severe disease and hospitalisation in response to the Omicron variant. Experts from across our organisation, in collaboration with colleagues throughout Europe, conducted rigorous assessments to ensure that newly authorised adapted vaccines continue to demonstrate extremely high levels of safety, effectiveness and quality. In addition to the authorisation of COVID-19 related therapies and vaccines, regulators from across the globe are currently undertaking a period of reflection to understand how best to retain and implement some of the extraordinary regulatory agilities introduced during the pandemic to support the accelerated development and authorisation of medicines. Indeed, the HPRA continue to engage with colleagues across Europe to ensure efficiencies in the regulation of medicines are retained, wherever possible.

Implementation of New Regulations

The past year was also a time of significant progress regarding the implementation of new legislative frameworks that will positively affect human health for many years. The new Medical Devices Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR), for example, will ultimately strengthen existing regulatory systems for medical devices and diagnostics across Europe. The regulations aim to provide, among other things, clearer requirements on clinical data for medical devices and in-vitro diagnostics (IVDs), more specific product requirements and enhanced provisions for market surveillance and performance assessment. Despite the clear and obvious benefits for patients and healthcare providers associated with the MDR and IVDR – in terms of an enhanced focus on clinical safety and innovation support – there are challenges that will need to be addressed before fully realising the system-strengthening opportunities provided by each regulation. Specifically, the coordinated and consistent application and operation of both regulations is critical to deliver for patients and ensure their success. The HPRA, in collaboration with colleagues from other European agencies, are providing leadership, influence and strategic direction to enhance cooperation and coordination within the EU regulatory system to deliver the successful implementation of MDR and IVDR.

We also saw the new Clinical Trials Regulation (CTR) coming into effect in January of this year. Like the MDR and IVDR, the CTR aims to maintain high standards of public transparency and safety for clinical trial participants, while at the same time demonstrating the EU offers an attractive and favourable environment for conducting clinical research on a large scale. The CTR enables sponsors to submit one application via a single online platform, known as the Clinical Trials Information System (CTIS), for approval to run a clinical trial in several European countries. In this way, it makes it more efficient to carry out such multinational trials. Following “golive” in January, the majority of trials submitted to the CTIS have been authorised (+75 trials), with many more currently under evaluation.

Despite the relative success of CTIS, submission numbers remain lower than expected at this time and users have experienced technical issues with the platform resulting in the delayed approval of applications. The European Medicines Agency (EMA), together with national regulatory authorities across Europe, including the HPRA, are working collaboratively to resolve high-priority technical issues associated with the CTIS. The goal for all involved is to enable the timely, effective, and efficient authorisation of clinical trials that are so important to facilitating patient access to innovative medicines.

Enhancing our Approach to the Management of Medicines Shortage Management

Indeed, a primary focus throughout 2022 was ensuring the continued availability of medicines to meet patient need through our role in coordinating the management of medicines shortages. The HPRA has recently conducted a review of national data associated with the underlying root causes of shortages from the previous twoyear period. This is with a view to establishing the next phase of our multistakeholder response to shortage management in Ireland. Key stakeholders, including healthcare professionals and pharmaceutical companies, were consulted on this review, with recommendations on ways to help prevent and mitigate the effect of medicines shortages on patients due for publication in the coming year. This represents an exciting new phase in our approach to managing a multistakeholder approach and ensuring the continued availability of critical medicines on the Irish market to meet patient needs.

HPRA Contributions in Europe

Finally, from a personal perspective, it was a great honour to be appointed to lead the EMA’s Management Board. What has been evident throughout the years of the pandemic is that EMA must remain agile, responsive, and ready to show leadership and solidarity in the context of significant developments in the operating environment. As chair, my focus will be to continue and further enhance the strong partnership between the EMA, national agencies and the European Commission. It is imperative that the EMA continues to deliver the highest standards of public health protection while maintaining its global reputation as a modern, progressive, and transparent regulator. This will be achieved through the continued close cooperation and partnership approach of the broader European medicines regulatory network. My role as chair of the EMA Management Board only serves to complements other HPRA staff holding prominent positions of influence at European level. Despite being a medium sized agency in the context of Europe, we continue to provide leadership on a range of important regulatory issues impacting public health.

Conclusion

As we look forward to 2023, I am excited to build on the achievements of the organisation throughout the year as we continue to work in partnership with colleagues from across the national public health system. This is in addition to our well-established commitment to the European, and increasingly global, regulatory network. While we have set ambitious goals and objectives for the coming year, I believe the HPRA will continue to excel in health product regulation through science, collaboration, and innovation.

Read more clinical features here

Read more of our latest news here