Global Regulators Explore Alignment Options During COVID-19
Supporting convergence, allowing greater regulatory flexibility and avoiding drug shortages were among key topics discussed by global regulators at the first of a series of bi-weekly exchanges organized by the International Coalition of Medicines Regulatory Authorities.
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A new system for monitoring the availability of medicines for treating COVID-19 patients will allow EU-level coordinated actions to address supply shortages in the best way.
At their second meeting on COVID-19, drug regulators from around the world have stressed the importance of large, multi-arm studies in generating the data needed for the approval of potential coronavirus therapies. The European Medicines Agency, which organized the meeting, has also announced a new coronavirus task force to identify promising drug candidates and help steer them through development to regulatory approval.
A draft EU guideline explains how disease registries can be used to supplement evidence in the pre-authorization phase and provide infrastructure for post-authorization evidence generation.