MHRA lays out its thinking on AI and medicines regulation - pharmaphorum

The Medicines and Healthcare products Regulatory Agency has published a document explaining how its regulatory processes will adapt to the era of AI and personalised medicines. The document forms part of the agency's MHRA Strategy 2030 plan, which sets out its approach. In the plan, the UK regulator describes AI as one of the 'defining medical technologies' of coming years. The publication was reported by pharmaphorum under the headline 'MHRA lays out its thinking on AI and medicines regulation.'

In the strategy, the agency pledged to deliver faster and more predictable regulatory decisions. It also proposed improving real-world evidence generation and regulation, and said that work would be assisted by AI. The plan sets out how the regulator's processes will change as AI and personalised medicines become part of the field the agency oversees. The document addresses both AI and personalised medicines, which the strategy treats as technologies that will shape regulation in the coming years.

The MHRA is the UK regulator whose remit covers medicines and healthcare products. Its strategy says the agency's regulatory processes will adapt to the era of AI and personalised medicines. The stated aims are faster and more predictable regulatory decisions, and improved real-world evidence generation and regulation, with AI assisting that work. The publication sets out how the regulator expects its processes to change as those technologies take hold in the field it oversees. Pharmaphorum reported the document under a headline describing the agency's thinking on AI and medicines regulation.