Current regulatory approaches for accessing potential COVID-19 therapies

被引：0

作者：

Vesa Halimi

Armond Daci

Simona Stojanovska

Irina Panovska-Stavridis

Milena Stevanovic

Venko Filipce

Aleksandra Grozdanova

机构：

[1] Faculty of Pharmacy,Department of Pharmacy, Faculty of Medicine

[2] University Ss. Cyril and Methodius,undefined

[3] University of Prishtina,undefined

[4] University Clinic of Hematology,undefined

[5] Medical Faculty,undefined

[6] University Ss. Cyril and Methodius,undefined

[7] University Clinic of Infection diseases and febrile conditions,undefined

[8] Medical Faculty,undefined

[9] University Ss. Cyril and Methodius,undefined

[10] University Clinic for Neurosurgery,undefined

[11] Medical Faculty,undefined

[12] University Ss. Cyril and Methodius,undefined

来源：

Journal of Pharmaceutical Policy and Practice | / 13卷

关键词：

COVID-19; Regulatory; EMA; FDA; Clinical studies; Compassionate use; Clinical practice; Off-label use; Emergency use;

D O I：

暂无

中图分类号：

学科分类号：

摘要：

This commentary aims to elaborate challenges in the regulatory approaches for accessing and investigating COVID-19 potential therapies either with off-label use, compassionate use, emergency use or for clinical trials. Since no therapies have been formally approved and completely effective and safe to date, the best clinical choice is acquired only after consistent and fair communication and collaboration between licensed clinicians, researchers, regulatory authorities, manufacturers and patients.

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