Report on the review of regulatory flexibilities/agilities as implemented by National Regulatory Authorities during COVID-19
The ICMRA and WHO joint report on the implemented regulatory flexibilities in COVID-19 framework has been published
The report brings together different regulatory flexibilities/agilities that National Regulatory Authorities (NRAs) had implemented to ensure that there was continuity with regulatory oversight on routine functions while allowing for timely development and approvals of medical products for Covid-19.
The main objective of this report is to foster transparency and information sharing of practices among NRAs, besides providing models or examples of practices that other limited resourced NRAs could consider and potentially adopt and adapt to their regulatory systems within the respective national legal frameworks.
The authors inform that the report contains specific limitations on the scope of considered products, sources of information, period of review of flexibilities, context of application and effectiveness of these flexibilities.