HPRA Launches Strategic Plan for 2021 – 2025: Delivering for Patients through Collaborative Health Product Regulation

News Category: Regulatory news

Date: 02/06/2021

The Health Products Regulatory Authority (HPRA) has today launched its Strategic Plan 2021 – 2025, setting out the strategic direction that will guide the regulator over the next five years as it seeks to deliver better outcomes for people and animals through value-driven regulation and partnerships.

This Strategic Plan is focused on ‘delivering for patients through collaborative health product regulation’ - reflecting the HPRA’s mission to regulate medicines and devices for the benefit of people and animals, and its updated vision of ensuring excellence in regulation through science, collaboration and innovation.

The HPRA’s new strategic plan centres on five key goals, incorporating a number of areas for high-level actions. These are:

Strategic Goal 1 - Health system partnerships: The HPRA will further strengthen the integration between health product regulation and healthcare delivery through enhanced partnership and collaboration across all levels of the health system. This will enable the HPRA to better support the safe use of health products in clinical practice and contribute to national and international efforts to address public health challenges.

Strategic Goal 2 - Progressive regulation: The HPRA will enhance its use of proportionate and adaptive regulatory approaches for improved patient outcomes. The includes maximising the opportunities presented by new legislation to enhance regulation of health products, strengthening the use of risk-based approaches to regulation, and promoting greater mutual reliance, regulatory harmonisation, and intelligence sharing among global regulators.

Strategic Goal 3 - Communication and engagement: The HPRA is committed to improving its models of engagement to strengthen public trust and confidence in the regulation of medicines and medical devices. It will do this by engaging consistently and clearly with stakeholders, including patients and the general public, as well as providing greater transparency and clarity around its role in protecting public and animal health, and by further development of communication channels and information resources.

Strategic Goal 4 - Enabling innovation: The HPRA will enhance its supports for innovation from discovery through to regulatory approval, promoting an agile and appropriate approach to the regulation of innovations, with specific emphasis on outreach and engagement with Irish researchers.

Strategic Goal 5 - Great people, great processes: An organisation is only as effective as its people and its processes. The HPRA will continue to develop and renew to ensure it has the talent and skills to successfully achieve its goals in an era of deeper connectivity and evolving work practices.

The Chair of the HPRA, Mr Michael Donnelly, says: “I look forward to working with my fellow Authority members in supporting the Chief Executive in the implementation of the 2021-2025 Strategic Plan. The HPRA organisation performed exceptionally for patients during the recent unforeseen challenges and this new plan sets out an ambitious and similarly patient-focused agenda for the future. During this 2021-2025 timeframe, the HPRA will endeavour to deliver outcomes that make a real difference in the lives of all who use medicines, medical devices, and other health products.”

According to Dr Lorraine Nolan, HPRA Chief Executive: “The unprecedented challenge of COVID-19, as well the significant impact of Brexit, has demonstrated the need for, and value of, working collaboratively across Europe and internationally, with the health system in Ireland, and with patients and the general public. Patients are the users of health products and our most important stakeholder group. We are committed through this plan to building greater engagement with patients which we believe will contribute to broader-based and better-informed regulatory decisions. Together with everyone that works at the HPRA, as well as our stakeholders, I look forward to delivering on this strategic plan and continuing to build a stronger and more impactful medicines regulatory system that puts patient safety first.”

For more information, please download the Strategic Plan for 2021-2025: Delivering for patients through collaborative health product regulation


For Further Information:

Káno Communications                           

Barry Dunning               083 167 4871

Siobhan Molloy             086 817 5066                             


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