Regulatory journey for COVID-19 vaccines at the EMA
11:05 AM - 11:30 AM
As COVID-19 affected the world in early 2020, EMA put in place rapid scientific advice procedures to identify promising candidates. The next key tool to accelerate timeframes has been rolling reviews which have enabled EMA to speed up the assessments of a promising medicine or vaccine candidate during a public health emergency. Pandemic task force experts (COVID-19 ETF) play a key role in supporting EMA’s human medicines committee (CHMP) as it decides when data are sufficient to start a rolling review and when a company can submit a formal marketing application which is subsequently processed under a shortened timetable by CHMP. Conditional marketing authorisations have helped to fast-track the approvals of COVID-19 vaccines and therapeutics, once the positive benefit-risk has been established, using less comprehensive sets of data which are completed after authorisation, relying on robust post-authorisation safeguards and controls.