In a bid to support the ongoing assessment, monitoring and transparency of medicines and vaccines in the fight against the spread of COVID-19, the European Medicines Agency (EMA) is publishing a monthly report detailing scientific advice and informal consultation details relating to COVID-19 medicines and vaccines reviewed by the COVID-19 EMA pandemic Task Force.
The creation and circulation of the EMA's COVID-19 monthly report is the latest step in its global efforts to save lives by expediting the development and approval of safe and effective treatments and vaccines.
The information included on the EMA COVID-19 monthly report consists of scientific advice and consultation information on the best methods and study designs for ensuring robust data collection; manufacturing, testing and laboratory recommendations in respect of quality standards. The report is intended to assist medicine and vaccine developers prepare for COVID-19 related marketing authorisation applications.
The EMA has made clear that it has assessed and will only assess COVID-19 medicines and vaccines in accordance with its usual quality, safety and effectiveness standards. Whilst it is assessing applications under the minimum timeframe necessary, the EMA emphasises that it has no intention to cut corners or encourage medicine or vaccine developers to do so in order to further speed up the processes of granting a marketing authorisation.
The EMA is also providing early support for medicine and vaccine developers by supporting early conversations to discuss their strategy for evidence-generation and suitable fast-track and accelerated development and approval processes. The EMA has not ruled out applying further flexibility where the shortening of a procedural step could have important public-health benefits in dealing with COVID-19 including granting conditional marketing authorisations and the use of the compassionate use programmes.
The EMA has also confirmed that it will continue to keep the European Commission suitably informed about all COVID-19 applications to speed up subsequent authorisation decisions.