Clinical Trials Information System

The Clinical Trials Information System (CTIS) is the online system for the regulatory submission, authorisation and supervision of clinical trials in the European Union and the European Economic Area. From 31 January 2023, all initial clinical trial applications in the European Union (EU) must be submitted via the Clinical Trials Information System (CTIS). CTIS is now the single-entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data. This follows a one-year transition, during which sponsors could choose whether to apply for a new clinical trial in the EU/EEA in line with the Clinical Trials Directive or under the new Clinical Trials Regulation (CTR), which entered into application on 31 January 2022.临床试验信息系统（Clinical Trials Information System，CTIS）是欧盟与欧洲经济区内用于临床试验监管申报、审批与监督的在线系统。自2023年1月31日起，欧盟境内所有初始临床试验申请均须通过CTIS提交。目前，CTIS已成为临床试验申办方与监管机构提交、评估临床试验数据的单一入口。上述制度调整历经一年过渡期，过渡期内申办方可选择按照《临床试验指令（Clinical Trials Directive）》，或是依据2022年1月31日正式施行的新版《临床试验法规（Clinical Trials Regulation，CTR）》，申请欧盟/欧洲经济区内的新增临床试验。

搜集汇总

背景与挑战

背景概述

Clinical Trials Information System（CTIS）是欧盟和欧洲经济区用于临床试验监管提交、授权和监督的在线平台。自2023年1月31日起，它成为所有欧盟临床试验申请的单一入口点，允许用户搜索自2022年1月31日以来发起的试验，并为赞助商和监管机构提供申请和管理功能。