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Regulatory watch: Structural and procedural characteristics of international regulatory authorities
Nature Reviews Drug Discovery ( IF 122.7 ) Pub Date : 2017-08-11 , DOI: 10.1038/nrd.2017.135
Anand B. Jain , Annette Mollet , Thomas D. Szucs

Drug reviewers in regulatory authorities (health authorities) around the world have the responsibility of evaluating safety, effectiveness and quality control data for a new drug before it is approved for marketing. The regulatory requirements, structure and processes of various regulatory authorities are different, making it

中文翻译:

监管观察:国际监管机构的结构和程序特征

全球监管机构(卫生当局)中的药品审查人员都有责任在批准新药上市之前评估其安全性,有效性和质量控制数据。各个监管机构的监管要求,结构和流程都不尽相同,
更新日期:2017-09-04
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