Improving access to new diagnostics through harmonised regulation: priorities for action.
Improving access to new diagnostics through harmonised regulation: priorities for action.
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DOI：
10.4102/ajlm.v3i1.123
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发表时间：
2014
影响因子：
1.1
通讯作者：
Peeling RW
中科院分区：
文献类型：
--
作者：
McNerney R;Sollis K;Peeling RW
新一代诊断测试正在开发中，可在护理点使用，通过早期检测和治疗可以挽救生命并减少传染病的传播。重要的是，发展中国家的患者能够以负担得起的价格立即获得这些产品。医疗产品的监管旨在确保安全和质量，同时平衡及时获得有益新产品的需求。目前发展中国家对诊断测试的监管变化很大，监管薄弱导致低质量的测试进入市场。然而，低效或过于严格的监管会导致不必要的延误、增加成本并成为创新和市场进入的障碍。制定国际标准和简化监管流程可以减少这些障碍。已经确定了四项优先活动，其中标准和协议的融合或数据的联合审查将是有利的：（1）采用共同的注册文件进行上市前批准； (2) 生产现场检查质量标准趋同； (3) 使用共同的评估方案以及数据的联合审查，以减少不必要的重复冗长且昂贵的临床性能研究； (4) 利用实验室网络进行上市后监督，以监测诊断设备的持续质量。在发展中国家采取和实施此类措施可以加速获得安全且负担得起的新诊断测试。
A new generation of diagnostic tests is being developed for use at the point of care that could save lives and reduce the spread of infectious diseases through early detection and treatment. It is important that patients in developing countries have access to these products at affordable prices and without delay. Regulation of medical products is intended to ensure safety and quality whilst balancing the need for timely access to beneficial new products. Current regulatory oversight of diagnostic tests in developing countries is highly variable and weak regulation allows poor-quality tests to enter the market. However, inefficient or overzealous regulation results in unnecessary delays, increases costs and acts as a barrier to innovation and market entry. Setting international standards and streamlining the regulatory process could reduce these barriers. Four priority activities have been identified where convergence of standards and protocols or joint review of data would be advantageous: (1) adoption of a common registration file for pre-market approval; (2) convergence of quality standards for manufacturing site inspections; (3) use of common evaluation protocols, as well as joint review of data, to reduce unnecessary duplication of lengthy and costly clinical performance studies; and (4) use of networks of laboratories for post-market surveillance in order to monitor ongoing quality of diagnostic devices. The adoption and implementation of such measures in developing countries could accelerate access to new diagnostic tests that are safe and affordable.