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Table 1 Legal basis, terminologies, and regulatory evidence for compassionate use, expanded access, and for early access scheme in COVID-19

From: The use of remdesivir outside of clinical trials during the COVID-19 pandemic

Regulatory agency Legal basis Terminology and other modalities Additional regulatory evidence for the use remdesivir in COVID-19, outside of clinical trials
Food and Drug Administration, FDA, USA 21 CFR 312 via 21CFR 312.300, 21CFR 312.305, 21CFR 312.310, 21CFR 312.315, 21CFR312.320 Expanded access for individual patients, in emergency use, for intermediate-size population, for widespread treatment use. NCT04323761 treatment IND/protocol [19];
NCT04302766 treatment IND/protocol [20];
Medicines and Healthcare Products Regulatory Agency (MHRA), UK Human Medicines Regulations 2012 (SI 2012/1916) Early access to medicines intended for more patients -Treatment protocol for healthcare professionals_ EAMS 11972/0002 remdesivir 100 mg concentrate for solution for infusion [21].
-Treatment protocol for healthcare professionals_EAMS 11972/0001 remdesivir 100 mg powder for concentrate for solution for infusion [22];
-Treatment protocol for patients_EAMS 11972/0001 remdesivir 100 mg powder for concentrate for solution for infusion [23];
-Treatment protocol for patients_EAMS 11972/0002 remdesivir 100 mg concentrate for solution for infusion [24];
-Treatment protocol on the pharmacovigilance system
-Information for medical directors [25];
-Early Access to Medicines Scientific Opinion-Public Assessment Report [26];
European Medicines Agency
EMA, European Union
Article 83 of Regulation (EC) No. 726/2004 Compassionate use is intended for a group of patients, although the approval, terminology and modalities are left within the remit of the National European Agencies. -Conditions of use, conditions for distribution and patients targeted, and conditions for safety monitoring addressed to member states for remdesivir available for compassionate use [16];
-Summary on compassionate use [27];