Regulatory authorities step up cooperation in connection with COVID-19
Further details on observational research
Regulatory authorities from around the world intend to cooperate more closely on observational research during COVID-19. To this end, they have identified three areas: Pregnancy research, medicines used in clinical practice, and monitoring the safety and efficacy of vaccines.
- Pregnancy research to examine the impact of both coronavirus disease and medication use on pregnant women infected with SARS-CoV-2 and on their unborn babies in order to support the development of COVID-19 treatments, risk management and the safety monitoring of medicines and vaccines;
- Building clinical cohorts of COVID-19 patients to share expertise and increase data quality in order to meet regulatory requirements and address existing knowledge gaps; and
- Prepare strong infrastructure for monitoring the safety and efficacy of vaccines against COVID-19 in order to rapidly detect and minimise risks to patients.