Supporting Regulatory Challenges in NI 


The Medicines and Healthcare products Regulatory Agency (MHRA) and partners across Northern Ireland, including Health Innovation Research Alliance Northern Ireland (HIRANI), led by the Department of Health NI have confirmed a strengthened programme of collaboration designed to support innovation, enhance patient safety and ensure people in Northern Ireland continue to benefit from world-class regulation of medicines and medical technologies. The agency has pledged to establish a clear point of contact in Northern Ireland.

Chief Pharmaceutical Officer, Catherine (Cathy) Harrison, welcoming the news said: “These actions mark an important step in strengthening the partnership with Department of Health NI and supporting Northern Ireland’s life sciences sector, building on commitments made at the recent Belfast visit by the board of the Medicines and Healthcare products Regulatory Agency.”

The MHRA said: “As part of this growing partnership:
We will expand the use and visibility of the MHRA Yellow Card scheme across Northern Ireland, building on existing work to strengthen surveillance of medicines and medical devices. This enhanced focus will support earlier detection of safety issues and reinforce our shared commitment to protecting patients.
We will continue to work together with Northern Ireland partners to ensure participation in cutting-edge research, accelerating the development of new therapies and reinforcing our shared ambition to improve health outcomes through evidence-based innovation.
We will establish an MHRA presence in Northern Ireland, providing a clear point of contact for local partners and supporting closer partnerships and engagement with industry, academia and the health system.
We will explore opportunities for the development of regulatory science and innovation in Northern Ireland, recognising the potential value this support could bring to clinical and regulatory science collaboration.

“This statement builds on commitments to collaborate that emerged from the first ever MHRA Board seminar held in Belfast in November 2025, co-chaired by MHRA Chair Professor Anthony Harnden and Chief Pharmaceutical Officer for Northern Ireland, Professor Cathy Harrison.

Brendan McGuigan, Director of Advanced Manufacturing & Engineering and Life Sciences Invest Northern Ireland said: “This is a significant step that will help NI innovators fully leverage our unique regulatory position and dual market access to both the UK and EU.

Such support strengthens our ability to drive innovation, attract investment, and showcase Northern Ireland as a hub for life and health sciences.”

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