Update on Global Regulators Meeting on COVID-19

On June 12, 2020, the International Coalition of Medicines Regulatory Authorities (ICMRA) met for the fifth time in a virtual meeting moderated by FDA’s Janet Woodcock, director of the Center for Drug Evaluation and Research, to discuss policy approaches to the COVID-19 pandemic. The group reviewed the principals for COVID-19 clinical trials and prioritization of compounds. Concerns about the discontinuation of clinical trials and the number of underpowered studies were expressed by the group. The use of COVID-19 clinical trial master protocols to accelerate treatment development was also discussed. The group is working to compare master protocols from different countries to identify possible overlaps.  

An update on clinical trials, potential therapies, and vaccines was given by the ICMRA Working Group on COVID-19. “Topics under discussion include ethical questions around human challenge trials and post-approval requirements for COVID-19 vaccines. ICMRA members agreed to analyze the regulatory flexibilities and extraordinary measures applied in different areas during the pandemic in order to identify practices that should be maintained or stopped after the public health emergency. The ICMRA COVID-19 Working Group will keep updating all ICMRA members on the progress of these initiatives,” the European Medicines Agency stated in a press release.