The Medicines and Healthcare products Regulatory Agency (MHRA) is the independent regulator of medicines, medical devices and blood components for transfusion in the UK. We operate in a statutory framework set by HM Government. Our responsibilities are to;
- ensure medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy (effectiveness)
- secure safe supply chains for medicines, medical devices and blood components
- promote international standardisation and harmonisation to assure the effectiveness and safety of biological medicines
- educate the public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components, leading to safer and more effective use
- enable innovation and research and development that is beneficial to public health
- collaborate with partners in the UK and internationally to support our mission to enable the earliest access to safe medicines and medical devices and to protect public health.
As a science-led organisation, the MHRA has a key role to play in enabling the UK to be a science and technology superpower by 2030. The agency is considering the opportunities and risks of Artificial Intelligence (AI), which has been identified as one of the five critical technologies in the UK Science and Technology Framework, from three different perspectives.
1. As a regulator of AI products
Where AI is used for a medical purpose, it is very likely to come within the definition of a general medical device, meaning it must meet the requirements of the UK Medical Devices Regulations 2002 (as amended) in order to be on the market in the UK. The MHRA is currently undertaking a programme of regulatory reform for medical devices. This includes ensuring there is proportionate regulation of AIaMD which takes into account the risks of these products without stifling the potential they have to transform healthcare.
2. As a public service organisation delivering time critical decisions
AI offers us the opportunity to improve the efficiency of the services we provide, across all our regulatory functions from regulatory science, through market access for medicines and medical devices, to post market surveillance and enforcement. More efficient regulatory services will lead to earlier access to medical products for UK patients and enable us to focus our talented resources more on priority activities that demand their advanced skills, such as enabling innovation and engaging with patients.
3. As an organisation that makes evidence-based decisions that impact on public and patient safety, where that evidence is often supplied by third parties
As a regulator of medical products we consider submissions, inspect premises and examine data relating to the products, protocols and practices we regulate. Increasingly, we expect AI to feature in how those we regulate undertake their activities and generate evidence. We need to ensure we understand the impact of that in order to continue to regulate effectively.
The Pro-innovation approach to the regulation of AI
The MHRA welcomed the publication of the Pro-innovation approach to the regulation of AI and has taken significant steps, in the 12 months since its publication, to adopt its recommendations into the work we do. The approach introduced five key principles.