International Collaboration on Pharmaceutical Regulations

An International Coalition of Medicines Regulatory Authorities (ICMRA) workshop, held on May 20, 2022 and co-chaired by Health Canada and the European Medicines Agency (EMA), highlighted lessons learned during the COVID-19 pandemic about the international collaboration on observational research. According to EMA, real-world evidence gathered from observational research assists regulators to understand the safety and effectiveness of medicines used in clinical practice.

Results from three technical ICMRA working groups that focus on vaccines, pregnancy observational research, and building international cohorts of patients were discussed in the workshop. Workshop participants agreed these platforms allowed for timely sharing of data, expertise, and tools.

Experience learned during the performance of observational studies based on COVID-19 real-world data was shared by the participants. It was agreed upon that rapid generation of evidence gained from active interactions between regulators, researchers, and academia is crucial for regulatory decision making in times public health crises.

Participants in the workshop included representatives from the World Health Organization and more than 28 medicines regulatory authorities. The findings from the workshop can be found on the ICMRA website.

Source: EMA