Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma
Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma
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DOI：
10.1038/nrd2664
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发表时间：
2008-10-01
影响因子：
120.1
通讯作者：
Breckenridge, Alasdair
中科院分区：
文献类型：
--
作者：
Eichler, Hans-Georg;Pignatti, Francesco;Breckenridge, Alasdair
在迅速获得新药的必要性与确保获得关于其益处和风险的全面数据的必要性之间找到适当平衡的挑战，给药物监管机构带来了越来越大的压力。这种困境并不新鲜，但最近备受瞩目的药物撤回和相互冲突的要求使其更加突出，包括一方面需要提高药物开发效率，另一方面需要避免使患者暴露于不必要的风险或可能无效的治疗。在这里，我们总结了利益相关者的当前需求以及面临的科学和监管问题，描述了现有和新兴的监管方法，并推测了未来的发展方向，例如当前监管模式从一次性上市许可到生命周期方法的演变。
Drug regulatory agencies are increasingly pressed by the challenge of finding the appropriate balance between the need for rapid access to new drugs and the need to ensure comprehensive data on their benefits and risks. This dilemma is not new, but has been made more prominent by recent high-profile drug withdrawals and conflicting demands, including the need to improve the efficiency of drug development on one hand, and the need to avoid exposing patients to unnecessary risks or possibly ineffective treatments on the other. Here, we summarize the current demands by stakeholders and the scientific and regulatory issues at stake, describe existing and emerging regulatory approaches, and speculate on future directions, such as evolution of the current regulatory model from a one-off marketing authorization to a life-cycle approach.