Introduction to special review and approval regulations of China Corona Virus Disease 2019 (COVID-19) drugs
1. History of special review and approval a. Initial definition: In the revised “Drug Registration Administration Law” of 2005, added special approval of “drugs necessary for emergencies”. This revised version was implemented on May 11th, 2005. b. Issuance of review and approval procedure: “Drug special review and approval procedure of State Food and Drug Administration”…