Amaral Rafael, Torre Carla, Rocha João, Sepodes Bruno
Faculdade de Farmácia, Universidade de Lisboa, 1649-003 Lisbon, Portugal.
Faculdade de Farmácia, Universidade de Lisboa, 1649-003 Lisbon, Portugal; Laboratory of Systems Integration Pharmacology, Clinical & Regulatory Science - Research Institute for Medicines (iMED.ULisboa), 1649-003 Lisbon, Portugal.
Drug Discov Today. 2021 Nov;26(11):2608-2618. doi: 10.1016/j.drudis.2021.06.019. Epub 2021 Jul 28.
In a globalized world, infectious diseases of international concern are inevitable. When they (re-)emerge, the regulatory system works towards mitigating their impact. Ebola outbreaks marked a turning point in regulatory preparedness and efforts led to the accelerated development of therapeutic agents, in a catastrophic environment. However, only one clinical trial determined a vaccine's efficacy. Key lessons were considered and applied thereafter. The collaborative work resulted in the approval of the first therapeutic options against Ebola, a milestone in public health preparedness. The response demonstrated the successful implementation of regulatory mechanisms fostering development, early access and assessment of therapeutic agents, and the flexibility to embrace innovative regulatory solutions. The current system is robust to address health crises and protect global health.
在全球化的世界中，具有国际影响的传染病难以避免。当这些疾病再次出现时，监管系统会努力减轻其影响。埃博拉疫情是监管准备工作的一个转折点，在灾难性的环境下，各项努力促使治疗药物加速研发。然而，仅有一项临床试验确定了一种疫苗的疗效。此后，人们吸取并应用了关键经验教训。通过合作，首批抗埃博拉治疗方案获得批准，这是公共卫生准备工作中的一个里程碑。此次应对行动展示了监管机制在促进治疗药物的研发、早期获取和评估方面的成功实施，以及采用创新监管解决方案的灵活性。当前的系统足以应对健康危机并保护全球健康。
