英國實施新法規以簡化醫療試驗流程
UK Implements New Regulations to Streamline Medical Trials
於2026年4月28日，英國發布了《2025年人用藥品（臨床試驗）（修正）條例》。
On April 28, 2026, the United Kingdom launched the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025.
這項由英國藥品及保健產品管理局（MHRA）與健康研究管理局（HRA）共同擬定的重大更新，旨在現代化英國的臨床試驗架構，以提升全球競爭力。
This major update, created by the MHRA and HRA, modernizes the UK's clinical trial framework to boost global competitiveness.
一項關鍵特色是法律明文納入的「聯合審查程序」，這讓申請人能提交一份申請文件，同時進行法規與倫理審查。
A key feature is the legally embedded combined review process, which lets sponsors submit one application for both regulatory and ethics approval.
此變更削減了行政作業負擔，並建立在先前已將試驗準備時間縮短超過25%的系統成功經驗之上。
This change cuts down administrative work and builds on the success of a system that already reduced trial setup times by over 25%.
透明度現已成為法律義務，要求試驗申請人公開註冊試驗，並在12個月內向參與者提供易於理解的結果摘要。
Transparency is now a legal obligation, requiring sponsors to register trials publicly and provide accessible result summaries to participants within 12 months.
此外，這些更新擁抱了電腦模擬與國際數據等現代技術，並將如「受試者」（ㄕㄡˋㄕˋㄓㄜˇ）等過時術語替換為「參與者」（ㄘㄢㄩˇㄓㄜˇ）。
Furthermore, the updates embrace modern technologies like computer simulations and international data, while replacing outdated terms like 'subject' with 'participant.'
透過聚焦於效率與包容性——鼓勵研究人員設計能更好地呈現多元族群的試驗——政府旨在使英國成為生命科學投資的首選之地，並確保病患能更快速地獲取創新的醫療治療。
By focusing on efficiency and inclusivity—encouraging researchers to design trials that better represent diverse populations—the government aims to make the UK a leading destination for life sciences investment and ensure patients gain faster access to innovative medical treatments.
