Monitoring of COVID-19 medicines
The European Medicines Agency (EMA) is making use of real-world data to monitor the safety and effectiveness of authorised COVID-19 treatments and vaccines and other medicines used in patients with COVID-19 in the European Union (EU).
EMA is taking steps to use real-world data from clinical practice to monitor the safety and effectiveness of COVID-19 treatments and vaccines and other medicines used in patients with COVID-19.
Information on ongoing COVID-19-related observational studies in the EU is available in the European Union electronic register of post-authorisation studies (EU PAS Register). Users can find these studies by entering 'COVID-19' in the 'Title of Study' search filter.
EMA and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) are encouraging all researchers to register their pharmacoepidemiological studies related to COVID-19 in the EU PAS Register.
They should also upload and make their study protocols public, with a description of the data collected, and include ‘COVID-19’ in the study title.
EMA has contracted institutions specialising in observational research to conduct several research projects detailed below. Click on the research areas to read more about each project.