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Regulatory meta-analyses for the evaluation of psychotropic medicines
The Lancet Psychiatry ( IF 30.8 ) Pub Date : 2017-09-01 , DOI: 10.1016/s2215-0366(17)30161-x
Corrado Barbui , Marianna Purgato , Giovanni Ostuzzi

Concern has been raised regarding the rules governing approval of psychotropic medicines by regulatory agencies, and the quality and transparency of evaluations.1–4 The European Medicines Agency (EMA) is responsible for scientific evaluation of medicines developed by drug companies for use in European countries. These evaluations are based on the results of studies done by the manufacturer and submitted to the EMA. Proof of efficacy relies on several standalone clinical studies, with no requirement to apply meta-analytical techniques.

中文翻译:

评估精神药物的法规荟萃分析



人们对管理机构批准精神药物的管理规则以及评估的质量和透明度表示关注。1-4欧洲药品管理局(EMA)负责对制药公司开发的用于欧洲国家的药品进行科学评估。这些评估基于制造商完成的研究结果并提交给EMA。疗效证明依赖于数项独立的临床研究,不需要应用荟萃分析技术。
更新日期:2017-09-07
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