GDP Inspection Responses: MHRA’s Expectations for AI Use in GxP Replies

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a new post entitled “Use of AI for GXP inspection responses: setting standards without stifling innovation” on the Inspectorate blog. The article focuses on submissions to the MHRA Compliance Teams following GxP inspections and is therefore also relevant for GDP-regulated activities.

The authors note: "AI can support better regulatory outcomes and improve patient safety. However, we have also encountered responses containing references to MHRA guidance that doesn't exist, citations of inappropriate regulatory frameworks, and responses to serious deficiencies that appear designed to mislead rather than address underlying problems."

Against this background, the blog sets out MHRA’s current expectations: inspection-related submissions must remain factually accurate and verifiable, technically reviewed, and signed off with clear accountability, irrespective of whether AI tools are used in drafting.

A more detailed summary of the blog post has been published in our GMP Newsletter.

The full blog post is available in the MHRA Inspectorate Blog.