Table 2 Technical guidelines for the research and development of COVID-19 vaccines published worldwide
From: COVID-19 vaccines: progress and understanding on quality control and evaluation
Agency/Organization | Guidance |
|---|---|
World Health Organization (WHO) | Relevant WHO technical documents for COVID-19 vaccines and other biologicals34 |
Considerations for evaluation of COVID-19 vaccines42 | |
Food and Drug Administration (FDA) | Development and licensure of vaccines to prevent COVID-1936 |
Emergency use authorization for vaccines to prevent COVID-1943 | |
National Medical Products Administration (NMPA) | Guiding principles for research and development technical of COVID-19 preventive vaccines (trial)38 |
Guiding principles for pharmaceutical research technical of COVID-19 preventive mRNA vaccines (trial)37 | |
Guiding principles for clinical evaluation of COVID-19 preventive vaccines (trial)40 | |
Guiding principles for clinical study technical of COVID-19 preventive vaccines (trial)41 | |
Technical points for research and evaluation of nonclinical efficacy for COVID-19 preventive vaccines (trial)39 | |
European Medicines Agency (EMA) | EMA considerations on COVID-19 vaccine approval44 |
Quality-related scientific guidelines that EMA considers most relevant for COVID-19 vaccine developers35 | |
Pharmaceuticals and Medical Devices Agency (PMDA) | Principles for the evaluation of vaccines against the novel coronavirus SARS-CoV-245 |
