1. As of April 2022, aside from the five vaccines already approved (Comirnaty, Spikevax, Vaxzevria, COVID-19 vaccine Janssen and Nuvaxovid) four applications are under review via rolling review mechanism for MA and many more vaccines are in clinical development. The European Public Assessment reports for the authorised products can be accessed here. COVID-19 vaccines | European Medicines Agency (europa.eu) https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/covid-19-vaccines Accessed 01/04/2022.
2. COVID-19 guidance: research and development | European Medicines Agency (europa.eu). https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/guidance-developers-companies/covid-19-guidance-research-development#rapid-procedures-section. Accessed 25/01/2022.
3. Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorisation applications | European Medicines Agency (europa.eu). https://www.ema.europa.eu/en/toolbox-guidance-scientific-elements-regulatory-tools-support-quality-data-packages-prime-marketing. Accessed 25/01/2022.
4. Good manufacturing practice | European Medicines Agency (europa.eu). https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice. Accessed 25/01/2022.
5. EDQM Questions and answers on OCABR | EDQM - European Directorate for the Quality of Medicines. https://www.edqm.eu/en/omcls-questions-and-answers-ocabr Accessed 25/01/2022.