CAJ | 학술논문

2012-11，国家药品审评中心发布“药物临床试验登记与信息公示平台”试行版，并于2013-11进行了一次重要升级。其登记和公示的要求和内容等均基于对国际上先进临床试验网站的调研基础之上，包括欧盟临床试验网站（ EU CTR）等。本文简要介绍EU CTR的建立、法规沿革以及登记和审核等相关内容，以帮助读者清晰认知这些问题，深入理解我国建设“药物临床试验登记与信息公示平台”的意义。
2012-11，국가약품심평중심발포“약물림상시험등기여신식공시평태”시행판，병우2013-11진행료일차중요승급。기등기화공시적요구화내용등균기우대국제상선진림상시험망참적조연기출지상，포괄구맹림상시험망참（ EU CTR）등。본문간요개소EU CTR적건립、법규연혁이급등기화심핵등상관내용，이방조독자청석인지저사문제，심입리해아국건설“약물림상시험등기여신식공시평태”적의의。
In November 2012 , Center for Drug Evaluation addressed the pilot version of “Platform for Registry and Publicity of Drug Clinical Tri-als”, which has been updated in November , 2013.The requirements for registry and publicity are on the basis of numerous surveys on advanced international clinical trials websites including the European Union Clini-cal Trials Register ( EU CTR).This article briefly introduces the interna-tional background while building of EU CTR , its legislation reform , registration and check, etc, to help readers get a clear awareness and un-derstand the significance of China Platform.