In April 2024, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a policy paper on its strategic approach to artificial intelligence (AI) [1]. It summarises the MHRA’s view on the UK government’s white paper on AI regulation published in 2023 [2] and is the agency’s response to the Secretary of State letter of 1 February 2024 [3].
The policy paper provides an update on the MHRA's use of AI as a regulator of AI products, as a public service organization delivering time-critical decisions and as an organization making evidence-based decisions that impact public safety.
In the policy paper, MHRA outline strategy on how incorporating AI into the MHRA’s regulatory processes could help the agency focus on key priorities such as innovation. MHRA highlights that AI offers ‘improved efficiencies’, enabling patients in the UK to safely access medical products earlier. In addition, as a regulatory authority, the processes and protocols required to assess submissions and examine data should ‘evolve in line with innovative AI’.
With this in mind, MHRA highlighted that they should be established as:
- a regulator of AI products
- a public service organization delivering time-critical decisions
- an organization making evidence-based decisions that impact on public and patient safety, where that evidence is often supplied by third parties.
In addition, MHRA stress that ‘AI is likely to be integral to ensuring effective product regulation and patient safety, and therefore measuring and understanding its impact is essential for the agency to remain an effective and innovative regulator’.
In summary, MHRA aims to embrace the use of AI in regulatory processes and post acceptance monitoring. In a statement, Dr Laura Squire, Chief Quality and Access Officer at the MHRA, said, ‘AI offers us the opportunity to improve the efficiency of the services we provide across all our regulatory functions from regulatory science, through enabling safe access for medicines and medical devices, to post market surveillance and enforcement’.
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References
1. Government UK. Impact of AI on the regulation of medical products [homepage on the Internet]. [cited 2024 May 22]. Available from: https https://www.gov.uk/government/publications/impact-of-ai-on-the-regulation-of-medical-products/impact-of-ai-on-the-regulation-of-medical-products
2. Government UK. A pro-innovation approach to AI regulation: government response [homepage on the Internet]. [cited 2024 May 22]. Available from:
https://www.gov.uk/government/consultations/ai-regulation-a-pro-innovation-approach-policy-proposals/outcome/a-pro-innovation-approach-to-ai-regulation-government-response#executive-summary
3. Government UK. Letter from DSIT and DHSC Secretaries of State to the Medicines and Healthcare products Regulatory Agency - HTML [homepage on the Internet]. [cited 2024 May 22]. Available from: https://www.gov.uk/government/publications/request-for-regulators-to-publish-an-update-on-their-strategic-approach-to-ai-secretary-of-state-letters/letter-from-dsit-and-dhsc-secretaries-of-state-to-the-medicines-and-healthcare-products-regulatory-agency-html
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