Current regulatory approaches for accessing potential COVID-19 therapies

Vesa Halimi; Armond Daci; Simona Stojanovska; Irina Panovska-Stavridis; Milena Stevanovic; Venko Filipce; Aleksandra Grozdanova

doi:10.1186/s40545-020-00222-6

Current regulatory approaches for accessing potential COVID-19 therapies

J Pharm Policy Pract. 2020 May 16:13:16. doi: 10.1186/s40545-020-00222-6. eCollection 2020.

Authors

Vesa Halimi¹, Armond Daci², Simona Stojanovska³, Irina Panovska-Stavridis³, Milena Stevanovic⁴, Venko Filipce⁵, Aleksandra Grozdanova¹

Affiliations

¹ 1Faculty of Pharmacy, University Ss. Cyril and Methodius, Skopje, North Macedonia.
² 2Department of Pharmacy, Faculty of Medicine, University of Prishtina, Prishtina, Kosovo.
³ 3University Clinic of Hematology, Medical Faculty, University Ss. Cyril and Methodius, Skopje, North Macedonia.
⁴ 4University Clinic of Infection diseases and febrile conditions, Medical Faculty, University Ss. Cyril and Methodius, Skopje, North Macedonia.
⁵ 5University Clinic for Neurosurgery, Medical Faculty, University Ss. Cyril and Methodius, Skopje, North Macedonia.

Abstract

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.

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