Regulatory Preparedness and Mitigation Strategy for Emergency Health Threats.

The Regulatory Preparedness and Mitigation Strategy for Emergency Health Threats (2020) focuses on dealing with emerging health threats such as coronavirus, ebola and others that could be caused by biological, chemical, environmental and other unknown triggers. The Strategy is meant to provide guidance on regulatory interventions during public health emergencies. This Strategy is not intended to health threats triggered by product related defects, which should be handled by product risk management plan that could deal with product specific incidents.
The strategy aims to ensure sustained access to innovative, safe, quality assured and effective medical products through mitigating medical products shortage during public health emergency situations. The Specific objectives are: 1) Initiate and coordinate scientific research and regulatory innovations involving relevant parties within and outside of Ethiopia during emergency situations; 2) Strengthen and coordinate authorization, surveillance and post-authorization follow-up of medicinal products relevant to emergency health response (e.g. vaccines and antivirals), medical devices (e.g. medical masks, shield, mechanical ventilators) and sanitizers (e.g. alcohol based, iodine based); 3) Provide special attention towards monitoring and authorization of clinical trials involving conventional and herbal products intended for the emergency situations; 4) Expedite the regulatory processes and introduce regulatory flexibilities during public health emergency for Emergency Use Authorization (EUA) so as to alleviate product shortages; 5) Detect, prevent and respond to substandard and falsified medical products circulating in the market taking advantage of shortages during public health emergencies; 6) Effectively communicate relevant information on timely basis to healthcare professionals, patients, general public and other relevant stakeholders; 7) As required, communicate, harmonize and coordinate with international and regional organizations to benefit from and contribute to global and regional efforts in response to public health emergencies; to expedite authorization of new and/or innovative products as part of efforts to improve access to available treatment options to the Ethiopian people during public health emergencies; 8) Ensure that EFDA have the appropriate tools and institutional framework for cocoordinated action for management of crises due to emergency public health threat