On 28 April 2026 the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) will enforce a new set of clinical‑trial regulations. The reforms aim to speed the launch of lower‑risk trials, introduce a fast‑track “Route B” modification pathway, and require registration and summary‑results publication. The new rules build on earlier successes that reduced combined safety and ethics review time from 169 to 122 days and cut the overall review process to an average of 41 days. The Route B pilot, run from October 2025 to March 2026, processed applications in about seven calendar days and received strong support from commercial sponsors. The changes seek to maintain safety while expanding access to new treatments and improving transparency.
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