Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, United Kingdom.
Clin Infect Dis. 2015 Oct 15;61Suppl 3:S135-40. doi: 10.1093/cid/civ553.
Improved diagnostic tests for tuberculosis case detection are urgently needed that are affordable, robust, and easy to use so that they can be implemented widely. The mandate of national regulatory authorities is to ensure the safety and effectiveness of diagnostics, protecting the population against unsafe products while expediting access to beneficial new devices. However, regulatory approval processes in the developing world are often complex, lengthy, and not transparent. Recent progress in building regulatory capacity using harmonized approaches will reduce duplication in clinical performance studies and manufacturing audits, facilitate information sharing through trust and mutual confidence building, and ultimately improve efficiency. These savings can be passed onto the consumers in the form of more affordable pricing and allowing new high-quality tests for tuberculosis to be introduced more quickly and without delay.
迫切需要改进结核病病例检测的诊断检测方法，这些检测方法应价格合理、稳健且易于使用，以便能够广泛实施。国家监管机构的任务是确保诊断试剂的安全性和有效性，在保护民众免受不安全产品危害的同时，加快有益的新器械的上市。然而，发展中国家的监管审批程序往往复杂、冗长且不透明。目前，通过采用协调一致的方法来建设监管能力，可减少临床性能研究和生产审计方面的重复，通过建立信任和相互信心促进信息共享，并最终提高效率。这些节省的成本可以以更实惠的价格转嫁给消费者，并使新的高质量结核病检测更快、更及时地推出，而不会出现延误。
