In May 2012 at a high-level seminar hosted by Brazil, just before the 65th World Health Assembly in Geneva, the importance of better coordinating international cooperation among Medical Regulatory Agencies (MRA) was highlighted. This action marked the begining of the coordinated effore to form the International Coalition of Medicines Regulatory Authorities (ICMRA). [1, 2]
In December 2013 the ICMRA was formed when 8 regulatory authorities came together to form the Coalition, with Health Canada as the chair. By 2023 it has attracted 38 global memebers with the World Health Organization as “an observer.”. [3, 4]
In August 2014, in the face of the Ebola outbreak, the 8 ICMRA members (pledged) “committed to enhanced cooperation with the World Health Organization (WHO) and between regulatory agencies” to encourage and fast track “potential new medicines, otherwise known as investigational treatment. This puts ICMRA in their “interim” phase. [5, 6] Then came Zirka in 2016.
On February 10, 2021 the coalition came together to decide what paramaters would be needed to authorise new versions of COVID-19 vaccines. They decided clincal trials would not be required. And so on June 24, 2021, only a few months after the COVID-19 vaccines rolled out around the world, the WHO released new ‘correlates of protection‘ to justify “vaccine efficacy” to authorise updated vaccines. [7, 8] So now every year a new “updated” vaccine can be justified!