The International Coalition of Medicines Regulatory Authorities (ICMRA) has released new recommendations to ensure efficient regulatory processes that will support the development of diagnostics and treatments for COVID-19.

Stemming from three virtual meetings with more than 100 participants, the ICMRA emphasizes the need for well-designed and large randomized controlled trials that will investigate the safety and efficacy of potential therapies for the virus.

In its statement, the ICMRA suggests that data from real-world evidence and observational studies may be necessary to complement the evidence gleaned from these randomized clinical trials. The ICMRA also wrote that it will work with pharmaceutical companies, distributors and manufacturers to help address drug supply issues and shortages during the pandemic.

The ICMRA also recognized in its recommendations the importance of addressing the COVID-19 crisis in low- and middle-income countries and populations, considering their higher risk for morbidity and mortality associated with COVID-19. The ICMRA recommends that access to medicines and medical devices, including vaccines once they become available, be ensured for these populations.