Regulators from around the world have agreed to cooperate on observational research during COVID-19.
A second workshop on observational studies of real-world data generated during clinical practice in the context of COVID-19 was co-organised by the European Medicines Agency (EMA) and Health Canada, under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), on 19 May 2020. Regulators agreed to step up cooperation in three priority areas;
- Pregnancy research: examining the impact of COVID-19 and potential medications on pregnant women, and on their unborn babies, to support COVID-19 medicine development, risk management, and planning for safety monitoring of vaccines and therapeutics.
- Building international cohorts of COVID-19 patients. Sharing expertise, increasing study power, and data quality to meet regulatory requirements, addressing existing knowledge gaps.
- Prepare strong infrastructure for monitoring the safety and efficacy of vaccines against COVID-19.
This strategy will not only contribute to COVID-19 response but also for all future international observational research. The meeting brought together participants from over 25 countries representing 28 medicines regulatory authorities and experts from the World Health Organization (WHO), which built upon experience and knowledge gained from the first workshop in April. More details on the discussions and outcomes will be shared in the coming days.