On February 17, the CDE official website showed that to guide the scientific R&D and evaluation of antiviral drugs against COVID-19 and to provide technical standards for reference, the Center for Drug Evaluation (CDE) formulated the Guideline on Clinical Trials of Antiviral New Drugs for Coronavirus Disease 2019 (Trial). In accordance with the requirements of the Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Procedures for Publishing Pharmaceutical Technical Guidelines (NMPA Comprehensive Department [2020] No. 9), and after review and approval by the National Medical Products Administration (NMPA), the guideline is hereby issued and shall take effect from the date of issuance.

This guideline applies to chemical drugs and therapeutic biological products (excluding non-specific immunoglobulins) used for antiviral treatment and prevention of COVID-19. It discusses the design of clinical trial protocols and key issues that require attention, aiming to provide general technical guidance and reference for the design, implementation, and evaluation of clinical trials of antiviral drugs against COVID-19.