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

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];