The UK’s MHRA approval of Tauvid comes four years after it was approved by the FDA. Credit: Ralf Liebhold via Shutterstock.

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has unveiled a new business plan to build on the launch of a three-year corporate plan. 

The new plan will build on the 2023 corporate plan which outlined four key priorities, including public trust, improved access to safe and effective products and the pursuit of new strategic partnerships. The MHRA said that the 2024/25 plan has a core focus of enabling access to new technologies while also ensuring continued access to healthcare products that “are the backbone of NHS healthcare”. 

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The MHRA said that another key focus will be improving service delivery for its customers. This includes boosting performance and clearing any remaining backlogs that built up during the pandemic, where its resources were redirected to the Covid-19 response. The agency also added that it will make its performance data more transparent to help customers better predict its services. 

The plans emphasis on service optimisation features the introduction of two new regulatory IT systems, dubbed SafetyConnect and RegulatoryConnect. The systems aim to help the MHRA quickly respond to safety concerns throughout the product lifecycle and make it easier to communicate and collaborate with stakeholders. 

June Raine, the MHRA’s chief executive said: “To take full advantage of today’s exciting developments in science and technology for the benefit of patients, we will focus on facilitating access to innovative new products while also ensuring continued access to well-established healthcare products that are the backbone of NHS healthcare.” 

The MHRA is responsible for regulating both medicines and medical devices in the UK. As part of its 2024/25 objectives, the agency said it will finalise several pathways, including the launch of a refreshed Innovative Licensing and Access Pathway (ILAP) by the end of Q3. The ILAP aims to accelerate the timeline to marketing authorisation of medicines in the UK. 

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It will also finalise the Innovative Devices Access Pathway (IDAP) pilot, completing evaluation to determine next steps to be implemented in 25/26 by the end of Q4. The IDAP pilot launched in 2022, backed with £10m funding. The aim of the scheme is to give an opportunity to streamline developments of technologies that address the clinical needs of the National Health Service (NHS) without sacrificing safety, quality, and efficiency. 

The MHRA has released several other reports this year, including one that sets out the call for regulation in the artificial intelligence (AI) health tech space. The paper suggested that many Class I devices using AI – able to be on the market without authorisation – could be bumped up to Class II.