The UK Medicines and Healthcare products Regulatory Agency (MHRA) said it will develop an AI protocol checker to help clinical trial sponsors align planned studies with regulatory expectations. The initiative targets the protocol-writing step—where amendments, missing elements, or inconsistent outcome definitions can lead to delays during review. An AI-assisted compliance tool may shift quality-control earlier in the development timeline. For sponsors and CROs, this signals a regulatory push toward machine-aided review and earlier harmonization, with potential implications for submission consistency and reviewer workload.