Disease due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to be an important public health problem. This concept paper addresses the need to develop a guideline on the non-clinical and clinical evaluation of antiviral medicinal products and monoclonal antibodies intended for the treatment and/or prevention of coronavirus disease 2019 (COVID-19) for which there is currently no regulatory guideline in the European Union.
The scope of the guideline will be limited to antiviral medicinal products and monoclonal antibodies (mAbs) that are directed specifically against the viral target SARS-CoV-2. Medicinal products that target the host’s immune system (for example those blocking the angiotensin-converting enzyme 2(ACE2) receptor or cytokines) will be out of scope of the document, as these require different considerations for evaluating their safety and efficacy. The development of vaccines to prevent COVID-19 will not be covered in this guideline.