英國更新法規以加速臨床試驗
UK Updates Regulations to Speed Up Clinical Trials
聯合王國已正式啟動二十年來最重大的臨床試驗法規改革。
The United Kingdom has officially launched the most significant overhaul of its clinical trial regulations in twenty years.
該法規於2026年4月28日生效，即《2025年人類用藥物（臨床試驗）（修訂）法規》，旨在將聯合王國打造為全球研究的首選目的地。
Enacted on 28 April 2026, the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 aim to transform the UK into a premier destination for global research.
政府希望透過擺脫僵化的架構，轉向靈活且與風險成比例的系統，以現代化整體環境，並加速將救命療法送達患者手中。
By shifting away from a rigid framework to an agile, risk-proportionate system, the government intends to modernize the landscape and accelerate the delivery of life-saving treatments to patients.
重要變革包括針對低風險研究的快速通知管道，以及第一期臨床試驗為期14天的評估時程。
Key changes include a fast-track notification route for low-risk studies and a 14-day assessment timeline for Phase 1 trials.
此外，新規整合了監管機構與倫理委員會的單一申請路徑，有效消除了重複的文書作業。
Furthermore, the new rules integrate a single application route for regulators and ethics committees, effectively eliminating duplicate paperwork.
此項改革亦擁抱現代科學，允許採用計算機模擬等創新方法。
The reforms also embrace modern science by allowing for innovative methods like computer-model simulations.
此一策略性舉措旨在簡化從申請到招募的流程，最終提升聯合王國在生命科學領域的競爭優勢，並確保該國持續站在醫療創新的最前線。
This strategic move aims to streamline the path from application to recruitment, ultimately boosting the UK’s competitive edge in the life sciences sector and ensuring that the country remains at the forefront of medical innovation.
