Ebola outbreaks: A stress test of the preparedness of medicines regulatory systems for public health crises.
Ebola
Epidemic
Health crises
Health threats
Regulatory preparedness
Regulatory systems
Journal
Drug discovery today
ISSN: 1878-5832
Titre abrégé: Drug Discov Today
Pays: England
ID NLM: 9604391
Informations de publication
Date de publication:
11 2021
11 2021
Historique:
received:
18
04
2021
revised:
17
05
2021
accepted:
14
06
2021
pubmed:
1
8
2021
medline:
17
3
2022
entrez:
31
7
2021
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 34332099
pii: S1359-6446(21)00329-9
doi: 10.1016/j.drudis.2021.06.019
pii:
doi:
Substances chimiques
Antiviral Agents
0
Ebola Vaccines
0
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
2608-2618Informations de copyright
Copyright © 2021 Elsevier Ltd. All rights reserved.