Speeding Access to Vaccines and Medicines in Low- and Middle-Income Countries: A Case for Change and a Framework for Optimized Product Market Authorization
Speeding Access to Vaccines and Medicines in Low- and Middle-Income Countries: A Case for Change and a Framework for Optimized Product Market Authorization
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DOI：
10.1371/journal.pone.0166515
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发表时间：
2016-11-16
期刊：
影响因子：
3.7
通讯作者：
Hartman, Dan
中科院分区：
文献类型：
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作者：
Ahonkhai, Vincent;Martins, Samuel F.;Hartman, Dan
背景：联合国千年发展目标激发了全球努力，通过前所未有的公私伙伴关系减轻世界上最贫穷人民的痛苦。捐助援助机构通过增加获得有质量保证的疫苗和药品的机会，显然挽救了数百万人的生命，否则这些人可能会死于疾病。然而，由于仍然缺乏了解的因素，在低收入和中等收入国家(LMIC)引入这些卫生干预措施仍然面临一段时间的滞后。方法和发现我们伙伴关系的一个反复出现的主题是，优化的监管程序将有助于改善获得高质量保健品的机会。因此，我们调查了LMICs目前的药品和疫苗注册制度，作为我们全面监管战略的一部分。在这里，我们报告了LMICs中用于治疗某些传染病的疫苗和药物的注册时间表的事实基础。我们与广泛的利益攸关方合作，包括世界卫生组织的资格预审小组、国家监管机构、制造商、采购商和其他专家，并收集了撒哈拉以南非洲产品注册申请首次提交和最后批准之间的时间表的数据。我们把重点放在传染病负担最重、对所研究产品的需求最大的国家。数据显示，从第一次向高收入国家的监管机构提交监管申请到撒哈拉以南非洲国家的最终批准之间，通常有4至7年的滞后。在这些国家，产品在交付之前经历的三个典型注册步骤中有两个涉及较长的时间。未能利用或依赖主管监管机构已经进行的审查的结果，各国对产品批准的不同要求，以及制造商回应监管询问的漫长时间，是造成延迟的关键潜在因素。结论我们与关键利益相关者密切合作，提出了一系列措施，可以缩短注册时间，并在最需要的国家更快地提供安全有效的药物。其中许多建议正由负责任的利益攸关方执行，包括世卫组织资格预审小组和撒哈拉以南非洲的国家监管当局。这些努力将是有关小组随后发表的出版物的重点。
Background The United Nations Millennium Development Goals galvanized global efforts to alleviate suffering of the world's poorest people through unprecedented public-private partnerships. Donor aid agencies have demonstrably saved millions of lives that might otherwise have been lost to disease through increased access to quality-assured vaccines and medicines. Yet, the introduction of these health interventions in low- and middle-income countries (LMICs) continues to face a time lag due to factors which remain poorly understood.Methods and Findings A recurring theme from our partnership engagements was that an optimized regulatory process would contribute to improved access to quality health products. Therefore, we investigated the current system for medicine and vaccine registration in LMICs as part of our comprehensive regulatory strategy. Here, we report a fact base of the registration timelines for vaccines and drugs used to treat certain communicable diseases in LMICs. We worked with a broad set of stakeholders, including the World Health Organization's prequalification team, national regulatory authorities, manufacturers, procurers, and other experts, and collected data on the timelines between first submission and last approval of applications for product registration sub-Saharan Africa. We focused on countries with the highest burden of communicable disease and the greatest need for the products studied. The data showed a typical lag of 4 to 7 years between the first regulatory submission which was usually to a regulatory agency in a high-income country, and the final approval in Sub-Saharan Africa. Two of the three typical registration steps which products undergo before delivery in the countries involve lengthy timelines. Failure to leverage or rely on the findings from reviews already performed by competent regulatory authorities, disparate requirements for product approval by the countries, and lengthy timelines by manufacturers to respond to regulatory queries were key underlying factors for the delays.Conclusions We propose a series of measures which we developed in close collaboration with key stakeholders that could be taken to reduce registration time and to make safe, effective medicines more quickly available in countries where they are most needed. Many of these recommendations are being implemented by the responsible stakeholders, including the WHO pre-qualification team and the national regulatory authorities in Sub-Saharan Africa. Those efforts will be the focus of subsequent publications by the pertinent groups.