MHRA publishes strategy on AI regulation

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a policy paper on its strategic approach to artificial intelligence (AI). It summarises the MHRA’s view on the UK government’s white paper on AI regulation published in 2023.

Following publication of this white paper, the government requested that the MHRA outline the steps the agency is working on in relation to its expectations.

Over the past year, MHRA asserted that it has taken “significant steps” to adopt these recommendations.

According to the MHRA, artificial intelligence offers “improved efficiencies”, enabling patients in the UK to safely access medical products earlier. Additionally, AI will afford the MHRA “greater scope” to focus specialist expertise on priorities such as innovation.

AI: an innovative approach

The agency stated that it relies on this evidence when considering for instance, submissions and when examining data. It asserted that as a regulator, these processes and protocols should “evolve in line with innovative AI”.

As such, the MHRA highlighted that it views the opportunities and risks that AI holds through the lens of being:

• a regulator of AI products
• a public service organisation delivering time-critical decisions
• an organisation making evidence-based decisions that impact on public and patient safety, where that evidence is often supplied by third parties.

“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…Increasingly, we expect AI to feature in how those we regulate undertake their activities and generate evidence,” commented Dr Laura Squire, Chief Quality and Access Officer at the MHRA.

MHRA predicted that in the future artificial intelligence “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”.

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