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Center for Drug Evaluation issued 5 guidances including the Technical Guidance for Research & Development of Prophylactic Vaccines for Novel Coronavirus (Interim)

CCFDIE| Updated: 2020-08-04

In order to guide the clinical research & development of COVID-19 vaccines in China and provide technical standards that can be used as references, upon the approval by the National Medical Products Administration (NMPA), CDE issued the Technical Guidance for Research & Development of Prophylactic Vaccines for Novel Coronavirus (Interim), Technical Guidance for Pharmaceutical Studies of Prophylactic mRNA Vaccines for Novel Coronavirus (Interim), Technical Essentials for Non-Clinical Effectiveness Study and Evaluation of Prophylactic Vaccines for Novel Coronavirus (Interim), Technical Guidance for Clinical Studies of Prophylactic Vaccines for Novel Coronavirus (Interim), and Guidance for Clinical Evaluation of Prophylactic Vaccines for Novel Coronavirus (Interim). The above Guidances shall come into effect as of the date of August 14, 2020.