HPRA Seeks Feedback to Inform Development on Regulatory Plan for 2021 to 2025

25 November 2019

GMP News

Ireland’s Health Products Regulatory Authority (HPRA) is seeking feedback to inform the development of its strategic plan for 2021 to 2025. HPRA wants input on how the sectors it regulates will change in the next five to 10 years and feedback on how well it currently communicates with stakeholders.

When HPRA established its current strategic plan, it set itself the objectives of optimizing regulatory systems, improving communication, supporting innovation, adding expertise and enhancing access to health products. Those goals have remained touchstones for HPRA over the subsequent years, but its efforts to meet them have been affected by external forces, notably Brexit and changing regulations at the European Union level.

HPRA highlighted Brexit and changing EU regulations as key drivers of its strategy for the next five years. With the consequences of the United Kingdom’s vote to leave the EU still uncertain, HPRA is unable to say how Brexit will affect its operations out to 2025 but it thinks “changes to the supply of some human or veterinary medicines and medical devices … cannot be ruled out.” HPRA also sees opportunities to fill the gap created by the UK’s departure from the EU regulatory network.

The impact of incoming EU regulations should be easier to predict, but outstanding questions about the implementation of rules on clinical trials, veterinary medicines and, in particular, medical devices and in vitro diagnostics means HPRA faces some uncertainty in these areas, too. HPRA expects the new rules to “impact significantly on the operation of the relevant regulatory system.”

HPRA mentioned innovation, partnerships and public trust as the other three key drivers of its 2021 to 2025 strategy. The agency expects these drivers to result in more collaborations and lead it to make its decision-making process more transparent.

While HPRA has identified the drivers of its next regulatory strategy, it is yet to develop the plan. To inform that work, HPRA has posed a set of questions to groups that will be affected by the strategy. HPRA wants feedback on the focus of its contribution to EU and international regulatory networks, its role in legislation and policy development and how well it communicates with stakeholders.

HPRA is accepting feedback until 13 December.




Read more


Read more

Media Center

Read more