Current regulatory approaches for accessing potential COVID-19 therapies

Current regulatory approaches for accessing potential COVID-19 therapies

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

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.

2020

FDA, clinical studies, regulatory, EMA, Compassionate use, COVID-19

DOI: 10.1186/s40545-020-00222-6

Journal of Pharmaceutical Policy and Practice

BMC

Therapeutics. Pharmacology, Pharmacy and materia medica