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本帖最后由 julia朱玉姣 于 2016-11-2 23:02 编辑
ComprehensiveOverview of global Initiatives on Medicine Regulation published 已发布的全球药事法规综合概览 The European Medicines Agency (EMA) has published an overview of existinginternational regulatory initiatives for human medicines, like for exampleInternational Council for Harmonisation (ICH), Pharmaceutical InspectionCo-operation Scheme (PIC/S), International Pharmaceutical Regulators Forum(IPRF) and International Coalition of Medicines Regulatory Authorities (ICMRA)members. EMA发布了一份现有国际人药法规的概览，例如ICH、PIC/S、IPRF和ICMRA成员。 题为“连接断点---向国际药事法规全球知识化进发：国际化倡议蓝图”的报告还列出了相应的国际项目，以及全球化倡议的数量和范围详情。 The aim of the mapping exercise is to raise awareness of ongoinginternational regulatory activities, help establish a basis for a morestrategic coordination to avoid duplication of efforts, and identify possiblegaps. 蓝图目标是使大家了解正在进行的全球法规倡议，帮助建立一个更为策略化的合作基础，避免重复工作，找出潜在的差距。 In the conclusion, EMA mentions that there is "a myriad ofinitiatives but no strategic coordination". So these mappings and analysesshould "strongly support the need for a global strategy to supportcooperation between international medicines regulators, to help avoid anoverlap of activities and make resources available for areas where gaps stillexist." 结论中，EMA提到现在有“一个倡议的金字塔但没有策略性合作”，因此，这些蓝图和分析应“坚定支持全球策略需求，支持国际药品监管机构之间的合作，帮助避免重叠活动，提供资源弥合仍存在空档的领域。”
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