Khadem Broojerdi Alireza, Alfonso Claudia, Ostad Ali Dehaghi Razieh, Refaat Mohamed, Sillo Hiiti Baran
Regulatory Systems Strengthening Team, Regulation and Safety Unit, World Health Organization, Geneva, Switzerland.
Front Med (Lausanne). 2021 Aug 13;8:722872. doi: 10.3389/fmed.2021.722872. eCollection 2021.
Regulatory preparedness for public health emergencies is critical. However, responses to past emergencies, such as the 2009 H1N1 influenza pandemic and medical product shortages, have revealed sizable gaps in countries' regulatory capacity and preparedness. A systematic analysis of the regulatory preparedness of countries around the world has not yet been performed. The purpose of this study was to analyze and document the current regulatory preparedness status, highlight the related gaps and challenges in order to propose strategic, harmonized, and sustainable regulatory solutions to improve future responses to public health emergencies. From 2016 to 2020, we used the World Health Organization (WHO)'s Global Benchmarking Tool (GBT), a standardized instrument for identifying national regulatory authorities' strengths and gaps, to analyze the regulatory preparedness of 84 Member States, 95% of which were low- or middle-income countries. We analyzed whether participating Member States had not implemented, displayed ongoing implementation, had partially implemented, or had fully implemented 10 of the GBT's 268 sub-indicators most relevant to regulatory preparedness for public health emergencies. Only 10 Member States (12%) that underwent benchmarking had fully implemented all 10 sub-indicators related to regulatory preparedness for public health emergencies; 34 (40%) had fully implemented ≥50% of the emergency sub-indicators, and 20 (24%) had not fully implemented any of the sub-indicators. With regard to individual sub-indicators, regulatory preparedness ranged from 19 Member States (23%) fully implementing reliance on clinical trial decisions of others to 45 (59%) fully implementing legal provisions to fast-track (or expedite) marketing authorization applications. Many WHO Member States have limited regulatory preparedness for a public health emergency. Strengthening regulatory systems and promoting Good Regulatory Practices and reliance in these countries, to enable efficient response to emergencies, should be a global health priority.
公共卫生突发事件的监管准备至关重要。然而，对过去突发事件的应对，如2009年甲型H1N1流感大流行和医疗产品短缺，暴露出各国监管能力和准备方面存在相当大的差距。尚未对全球各国的监管准备情况进行系统分析。本研究的目的是分析并记录当前的监管准备状况，突出相关差距和挑战，以便提出战略、协调且可持续的监管解决方案，以改善未来对公共卫生突发事件的应对。2016年至2020年期间，我们使用了世界卫生组织（WHO）的全球基准工具（GBT），这是一种用于识别国家监管当局优势和差距的标准化工具，对84个成员国的监管准备情况进行了分析，其中95%为低收入或中等收入国家。我们分析了参与的成员国是否未实施、正在实施、部分实施或已全面实施GBT的268个分指标中与公共卫生突发事件监管准备最相关的10个指标。接受基准评估的成员国中，只有10个（12%）全面实施了与公共卫生突发事件监管准备相关的所有10个分指标；34个（40%）全面实施了≥50%的应急分指标，20个（24%）未全面实施任何分指标。就个别分指标而言，监管准备情况差异较大，从19个成员国（23%）全面实施依赖其他方的临床试验决定，到45个（59%）全面实施加快（或加速）上市许可申请的法律规定。许多世卫组织成员国对公共卫生突发事件的监管准备有限。加强这些国家的监管体系，促进良好监管实践和信任，以实现对突发事件的有效应对，应成为全球卫生的优先事项。
