Monitoring of COVID-19 medicines
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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).
The pharmacovigilance plan for COVID-19 vaccines sets out how EMA and the national competent authorities in the EU Member States identify and evaluate any new information that arises promptly, including any safety signals that are relevant for the benefit-risk balance of these vaccine:
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.
Real-world monitoring complements EMA's regular safety-monitoring activities, including spontaneous reporting of suspected side effects by patients and healthcare professionals.
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.