“We warmly welcome the MHRA’s commitment to establishing a presence here in Northern Ireland.
“This is a landmark moment for our health and life sciences sector, having direct, on-the-ground regulatory expertise available to our innovators from early-stage startups to established industry partners; R&D institutes and devolved government officials,” said HIRANI CEO following a meeting this week on making the regulatory process in NI a lot smoother with a dedicated MHRA presence in the region.
“This will be genuinely transformative in enabling equitable access to diagnostics, clinical trials and new therapies for patients.
“It will help streamline the path to market for local industry, and attract investment, accelerating the development of cutting-edge treatments and health technologies.
“Northern Ireland’s dual regulatory position has created additional complexity; but with MHRA now firmly alongside us, we can unlock dual market access with our closest neighbours and beyond with global stakeholders, turning it into our unique competitive advantage,” said Joann.
MHRA CEO Lawrence Tallon said: “Another brilliant visit on behalf of the Medicines and Healthcare products Regulatory Agency to Belfast.
Thank you to colleagues from the Department of Health – Northern Ireland, Department of Economy, Health Innovation Research Alliance Northern Ireland (HIRANI) and Invest Northern Ireland for warmly welcoming us again, as we continue working closely together on our shared ambitions.
We continue the conversations we have been having over the last year to make tangible progress on:
• Spreading the uptake of the yellow card system, including building it into existing electronic record systems where possible
• Ensuring that the dual regulatory framework (UK and EU) smoothly facilitates clinical trials using companion diagnostics – we are now confident there should be no regulatory impediment to clinical trials in NI on this basis
• Sharing the emerging work of the National Commission on the Regulation of AI, ensuring that NI is well placed to accelerate the development and adoption of healthcare AI building on its strong tech economy
• Enabling clinical innovators and entrepreneurs to access clear and effective regulatory pathways across the UK and beyond
• Strengthening the MHRA’s presence in, and engagement with, the NI health ecosystem.”
