Europe – Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3

As part of its coordinated response to the pandemic, the International Coalition of Medicines Regulatory Authorities (ICMRA) convened its regular high-level meeting of regulators from around the world on 27 May 2020 to discuss COVID-19 policies, regulatory aspects of  COVID-19 medicine development and pragmatic approaches to address challenges posed by the ongoing pandemic.

ICMRA has established a COVID-19 Working Group to provide in-depth recommendations on priority topics in the context of COVID-19. The main purpose of this working group is to draw on the expertise of regulatory authorities worldwide and assist the coalition in addressing concerns and issues raised during its strategic discussions on policies and regulatory flexibility. The working group held its first meeting in May and will initially work on regulatory criteria for the prioritisation of COVID-19 vaccines, guidance on the prioritisation of clinical trials and the coordination of trial registries. The ICMRA COVID-19 Working Group is chaired by Health Canada and is composed of several delegates from the ICMRA membership.

Participants of the high-level meeting exchanged information about the growing number of medicines that are in development or in clinical trials to assess their safety and efficacy for the treatment or prevention of COVID-19. They noted that clinical trials must be adequately powered, well-designed and include a control arm with standard of care (i.e. standard treatment) to generate evidence upon which decisions can be based. It was highlighted that, as new information is produced continuously, there is the risk for trials to be discontinued early without producing the necessary evidence and knowledge. Participants recommended that, provided the safety of trial participants is ensured, clinical trials should not be discontinued prematurely. They acknowledged the importance of striking a balance between speed and safety by supporting the rapid development of COVID-19 treatments but also insisting on the generation of robust data to demonstrate their safety and efficacy and enable decision-making…