The Medicines and Healthcare products Regulatory Agency (MHRA) has published a new Delivery Plan for the 2021-2023 time period. “Putting patients first: A new era for our agency” is the title of the document, which aims to put a “constant focus on delivering meaningful outcomes for patients”. The plan sets out 14 objectives, and is grouped into six central areas: scientific innovation, healthcare access, patient safety, dynamic organisation, collaborative partnerships and financial sustainability.

Patient involvement, and that from the public, is vital to ensure the success of the MHRA in future. The plan sets out the life sciences sector can be empowered through the scientific expertise the MHRA offers, how future regulatory approaches can be created, and new regulation for emerging technologies and product trends within healthcare, such as Artificial Intelligence (AI). Patient safety is the central tenet of MHRA’s role, and this will be maintained in future in line with the highest standards.

The plan addresses the challenge of MHRA creating a new business model that provides a financially sustainable future and preparing for the end of its operation as a Trading Fund and inclusion within the Department of Health and Social Care’s accounting boundary. MHRA plans to launch a new service that assists in the rapid recruitment of patients into commercial clinical trials, with the first contract in place by Q3, 2021/22; and offer this service to companies as standard by Q2, 2022/23; and by Q4, 2021/22 achieve 1 in every 4 UK GP practices signed-up to this clinical practice research data service. A consultation on legislation ensure safe access to innovative products will take place from Q1 2021/2022. Another public consultation will be launched covering all key aspects of proposed new market access framework by the end of Q2, 2021/22.

“Our Delivery Plan sets out our ambition plainly and prioritises the steps we are taking to achieve it: integrating our undeniable assets in science and regulation; building the UK and international partnerships we need to support our delivery; and taking the necessary decisions to improve our organisational resilience” said Stephen Lightfoot, Chair of the MHRA.