阿拉伯联合酋长国干细胞临床试验的监管前景

Y. Castillo-Aleman, Y. Ventura-Carmenate, R. A. Rivero-Jiménez, Antonio Bencomo-Hernández
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引用次数: 0

摘要

健康研究和临床试验正在推动有价值的医学知识的发展。近年来,阿拉伯联合酋长国(阿联酋)的政府和私营保健提供者进行了许多类型的临床研究,越来越多的出版物和以阿联酋为基础的临床试验已在世界范围内注册。然而,在管理新兴干细胞疗法的政策方面,阿联酋之间存在很大差异。本文旨在讨论在阿联酋开展涉及干细胞治疗的临床试验的监管框架。在国际注册和国家数据库中检索了以阿联酋为基础的干细胞临床试验。两个卫生当局正在领导干细胞和再生医学的监管事务:阿布扎比卫生部和迪拜卫生局,而公共数据库显示了在阿联酋调查干细胞的7项研究。我们建议加强卫生当局与受管制方之间的组织间关系。
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Regulatory Prospects of Clinical Trials with Stem Cells in the United Arab Emirates
Health research and clinical trials are driving the development of valuable medical knowledge. Many types of clinical research have been conducted in the United Arab Emirates (UAE) by governmental and private health providers in recent years, and a growing number of publications and UAE-based clinical trials have been registered worldwide. However, there are wide differences between the Emirates regarding the policies governing emerging stem cell therapies. This article aims to discuss the regulatory framework for conducting clinical trials involving stem cell therapies in the UAE. UAE-based clinical trials with stem cells were searched in international registries and national databases. Two health authorities are leading regulatory affairs on stem cells and regenerative medicine: The Department of Health - Abu Dhabi and Dubai Health Authority, while the public databases revealed 7 studies that investigated stem cells in the UAE. We recommend increasing the inter-organizational relationships between health authorities and regulated parties.
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