This report considers how the experience of the European regulatory system might be applied to help strengthen the regulatory systems for medicines in the Region of the Americas. The work of the European Medicines Agencies (EMA) is carried out through its scientific committees, composed of members from European Economic Area countries. A robust legal framework allows EMA to coordinate resources from Member States' competent authorities, including, for example, assisting candidate countries as they prepare to join the European Union (EU). Capacity-building programs help countries adjust their regulatory systems ahead of full participation in the European medicines regulatory network. These programs facilitate adoption of common technical requirements, identify areas where action might be needed to ensure the smooth transposition of EU pharmaceutical law into national legislation, and prepare candidate countries for participation in EMA committees and the European regulatory network. The methodology of these programs could be of potential interest to the Pan American Health Organization (PAHO), the Regional Office of the World Health Organization for the Americas. Given resolutions adopted by the World Health Assembly and the PAHO Directing Council, there is a strong indication that the countries of the Region of the Americas wish to assemble a system that uses the existing regulatory capacity of some countries to strengthen local regulatory capacities in others.

译文

本报告考虑了如何应用欧洲监管体系的经验来帮助加强美洲地区的药品监管体系。欧洲药品机构 (EMA) 的工作是通过其科学委员会进行的,该委员会由来自欧洲经济区国家的成员组成。健全的法律框架使EMA可以协调成员国主管当局的资源,例如,在准备加入欧盟 (EU) 时协助候选国。能力建设计划帮助各国在全面参与欧洲药品监管网络之前调整其监管体系。这些计划有助于采用共同的技术要求,确定可能需要采取行动以确保将欧盟制药法顺利转换为国家立法的领域,并为参与EMA委员会和欧洲监管网络的候选国家做准备。这些计划的方法可能会引起世界卫生组织美洲区域办事处泛美卫生组织 (PAHO) 的潜在兴趣。鉴于世界卫生大会和泛美卫生组织指导理事会通过的决议,有强烈迹象表明,美洲区域各国希望建立一个利用一些国家现有监管能力加强其他国家地方监管能力的系统。

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