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首页> 外文期刊>Pharmaceutical medicine >The Saudi Arabia Food and Drug Authority: An Evaluation of the Registration Process and Good Review Practices in Saudi Arabia in Comparison with Australia, Canada and Singapore
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The Saudi Arabia Food and Drug Authority: An Evaluation of the Registration Process and Good Review Practices in Saudi Arabia in Comparison with Australia, Canada and Singapore

机译:沙特阿拉伯食品和药物权威:与澳大利亚,加拿大和新加坡相比,沙特阿拉伯注册过程和良好审查实践评估

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Abstract Objective This study compares the current regulatory review process and good review practices at the Saudi Food and Drug Authority (SFDA) with those of regulatory agencies in Australia, Canada, and Singapore and identifies opportunities for developing the SFDA as a Regional Centre of Excellence. Methods A questionnaire completed by the SFDA included data regarding the organisation, key milestones, review timelines, and good review practices of the agency. Similar information was obtained within the same time-frame (2014/2015) through the same standard questionnaire regarding the processes and practices for Health Canada, Singapore's Health Sciences Authority, and Australia's Therapeutic Goods Administration.
机译:摘要目的本研究将沙特食品和药物管理局(SFDA)与澳大利亚,加拿大和新加坡的监管机构(SFDA)的良好审查做法进行了比较,并确定了将SFDA作为区域卓越中心发展的机会。 方法SFDA完成的问卷包括有关组织,主要里程碑,审查时间表和原子能机构的良好审查实践的数据。 通过相同的标准问卷在加拿大卫生部,新加坡卫生科学管理局和澳大利亚的治疗机构管理局以及澳大利亚的治疗机制管理中获得类似的信息。

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