EMA – Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19

In a high-level meeting on COVID-19 policies, organised by EMA under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators from around the world discussed strategic issues and regulatory approaches to ensure a coordinated response to the pandemic. They stressed the need for alignment on pre- and post-authorisation regulatory requirements to facilitate the rapid development, evaluation and availability of medicines for the treatment and prevention of coronavirus disease.

 The participants focused on regulatory considerations and challenges related to the development of medicines and vaccines for the prevention and treatment of COVID-19. They raised concerns about multiple small, rather than large clinical trials and stressed the need for the development of priority criteria for planned trials. In addition, they called for the inclusion of vulnerable or neglected populations, such as pregnant women, children and elderly people in COVID-19 studies. The regulators reiterated that it is crucial to align on common study protocols to ensure that the results meet regulatory requirements and allow the evidence to be used to support the approval of medicines or vaccines. 

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